Thermo Scientific gibco CTS DynaCellect Magnetic Separation System User Manual
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Thermo Scientific gibco CTS DynaCellect Magnetic Separation System User Manual

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CTS
DynaCellect
™
System
USER GUIDE
Catalog Number  A55867
Publication Number   MAN0026480
Revision   A.0
For Research Use or Manufacturing of Cell, Gene, or Tissue- Based
Products. CAUTION: Not intended for direct administration into
humans or animals.
Magnetic Separation
™

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Summary of Contents for Thermo Scientific gibco CTS DynaCellect Magnetic Separation System

  • Page 1 DynaCellect Magnetic Separation ™ ™ System USER GUIDE Catalog Number  A55867 Publication Number   MAN0026480 Revision   A.0 For Research Use or Manufacturing of Cell, Gene, or Tissue- Based Products. CAUTION: Not intended for direct administration into humans or animals.
  • Page 2 Life Technologies Holdings Pte Ltd | Block 33 | Marsiling Industrial Estate Road 3 | #07-06, Singapore 739256 For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition. Revision history:  Pub. No.   MAN0026480 Revision Date Description 13 October 2022 New document for CTS DynaCellect Magnetic Separation System.

  • Page 3: Table Of Contents

    Contents ■ CHAPTER 1   Product information ..........8 Product description .
  • Page 4 Contents ■ CHAPTER 3   Embedded graphical user interface (eGUI) user instructions . . . 33 Home screen ..............33 User interface overview .
  • Page 5 Contents Enable OPC-UA ............. . 108 Import protocol for OPC-UA .
  • Page 6 Contents ■ CHAPTER 7   Safety instructions ..........155 Labels .
  • Page 7 Contents Informational symbols ........... . . 183 Symboles d’information .

  • Page 8: Chapter 1   Product Information

    Product information IMPORTANT! Before using this product, read and understand the information in the “Safety” appendix in this document. Product description The Gibco DynaCellect Magnetic Separation System is an instrument for automated, magnetic ™ ™ ™ cell separation and bead removal. The instrument is accommodated by single-use fit-for-purpose kits for cell isolation and bead removal.

  • Page 9: Single-Use Kits

    Chapter 1 Product information Instrument features Single-Use Kits The CTS DynaCellect Cell Isolation Kit and the CTS DynaCellect Bead Removal Kit are specifically ™ ™ ™ ™ designed Single-Use Kits for a range of cell processing applications such as isolation, depletion and bead removal.

  • Page 10: Contents

    Chapter 1 Product information Contents Contents Table 1   CTS DynaCellect Magnetic Separation System (Cat. No. A55867) ™ ™ Component Quantity DynaCellect Magnetic Separation System ™ ™ Power cord Ethernet cable Pole extension Bag hanger Pole adaptor Quick reference guide Installation guide Required materials not supplied Unless otherwise indicated, all materials are available through thermofisher.com. Catalog numbers that appear as links open the web pages for those products.

  • Page 11: Clinical Manufacturing Mode

    Chapter 1 Product information System overview – Rocker angle: -30° to 30° – Rocker speed: 1–30 CPM (cycles per minute) • Export summary reports (sample ID, run ID, Single-Use Kit lot, bead lot, operator, date) • DeltaV system communication via OPC UA (under development) ™...
  • Page 12 Chapter 1 Product information System overview Figure 1   Front view USB port Pole extension Emergency stop button Pole adaptor Embedded Graphical User Interface (eGUI) Bag hanger Tube guide for upstream or downstream connection Pinch valve Rocker guard Fluidic panel Rocker with integrated magnet Pressure occlusion sensor Leakage detection sensor and overfill detector Peristaltic pump Tube guide...
  • Page 13 Chapter 1 Product information System overview Figure 2   Rear view Exhaust filter USB 2.0 port USB wireless adaptor port Ethernet Power switch Power cable inlet DynaCellect Magnetic Separation System User Guide ™ ™...

  • Page 14: Instrument Dimensions

    Chapter 1 Product information System overview Instrument dimensions The dimensions for the CTS DynaCellect Magnetic Separation System are: ™ ™ • Height: 19" (495 mm with pole base), 17" (434 mm without pole base) • Width: 29.5" (749.5 mm) • Depth: 22.12" (562 mm) Working space The CTS DynaCellect Magnetic Separation System is designed for benchtop use and requires a...

  • Page 15: Product Specifications

    Chapter 1 Product information System overview Product specifications Category Property Value Electrical Supply voltage 100–240 VAC ±10%, 50/60 Hz, 600 W Phases Single Maximum rated input current 6 A Fuses 2 × 10 A Instrument Regulatory requirements HEPA filter meets ISO 14644-14 Installation category Instrument type Benchtop/cart unit Instrument dimensions 495 mm (19") with pole base/ 434 mm (17") without pole...
  • Page 16 Chapter 1 Product information System overview (continued) Category Property Value Pinch valves Open/Closed Pump speed 10–150 mL/min Rocker angle -30° to 30° Rocker speed 1-30 CPM (cycles per minute) Pressure occlusion sensor Max 2 Bar. Only detect liquid pressure (not pressure build up by air).

  • Page 17: Cts ™ Dynacellect ™ Single-Use Kit Schematic

    Chapter 1 Product information System overview DynaCellect Single-Use Kit schematic ™ ™ PVC tubing Tube holder Silicone tubing Sterile air filter Oetiker clamps Cassette Bioprene tubing Isolation 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] •...

  • Page 18: Tube Sets Volume Overview

    Chapter 1 Product information System overview PVC tubing Tube holder Silicone tubing Sterile air filter Oetiker clamps Cassette Bioprene tubing Bead removal bag Figure 4   CTS DynaCellect Bead Removal Kit (Cat. No. A52301) ™ ™ • 4 weldable PVC lines [150 mm (5.91") (length), 2.4 mm (0.094") ID, 4.0 mm (0.157") OD] •...
  • Page 19 Chapter 1 Product information System overview Figure 5   Tube types and thickness Cell isolation kit (left) and Bead removal kit (right) PVC: 0.094 in ID 0.157 in OD; 2.4 mm ID 4.0 mm OD Silicone: 0.125 in ID 0.25 in OD; 3.2 mm ID 6.4 mm OD Bioprene: 0.125 in ID 0.25 in OD; 3.2 mm ID 6.4 mm OD The dead volume is calculated based on tube diameter and length, using the following formula: V = A h Since the area of a circle = π...
  • Page 20 Chapter 1 Product information System overview G H I 0.7 0.7 0.7 0.7 0.7 0.7 0.7 10.4 3.6 4.0 3.1 3.2 2.9 2.9 3.1 0.8 4.1 1..3 2..3 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. PVC: mL per in: 0.11;...

  • Page 21: Single-Use Kit Packaging

    Chapter 1 Product information System overview Single-Use Kit packaging PE foam (top) Corrugated, partition set PE foam (cut sheet) Die cut box PE foam (bottom) Shipper box 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) DynaCellect Magnetic Separation System User Guide ™...

  • Page 22: Wetted Components

    Chapter 1 Product information System overview Wetted components Component Description Material Pumping tubing Bioprene tubing 3.2 mm ID, Bioprene 6.4 mm OD (0.125 in ID, 0.25 in Kit tubing Tygon ND-100-65 Non DEHP tubing 2.4 mm ID, 4.0 mm OD (0.094 in ID, 0.157 in OD) Sanitech STHT-C Platinum Cured Silicone Tubing 3.2 mm ID, 6.4 mm OD...

  • Page 23: Chapter 2   Installation And Setup

    Installation and setup Packaging contents • CTS DynaCellect Magnetic Separation System instrument ™ ™ • Power cord • Ethernet cable • 2 Pole extensions • 2 Bag hangers • 2 Pole adapters • Quick reference quide • Installation guide Upon receiving the instrument •...

  • Page 24: Unpack The Instrument

    Chapter 2 Installation and setup Unpack the instrument Unpack the instrument To prevent condensation, the instrument should be left in its protective, antistatic plastic wrapping until the ambient temperature has been reached. • The instrument weighs 49.75 kg (109.7 lbs) (50.6 kg/111.6 lbs with poles and bag hangers) and requires at least two people to lift.
  • Page 25 Chapter 2 Installation and setup Unpack the instrument 2. Remove the two small cardboard boxes. 3. Remove the top foam. Top foam DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 26 Chapter 2 Installation and setup Unpack the instrument 4. Unwrap the packaging bag and remove the ethernet cable and power cord. 5. Lift the instrument 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. DynaCellect Magnetic Separation System User Guide ™...
  • Page 27 Chapter 2 Installation and setup Unpack the instrument 6. Remove the rocker homing position foam from the side. Once the rocker has been permitted to fall to its extreme (±30°) resting position, users should not attempt to force it out of position. There is risk to damage bearings and the motor if excessive force is applied after the rocker has moved to its resting position.

  • Page 28: Installing The Instrument

    Chapter 2 Installation and setup Installing the instrument Installing the instrument Prepare bench space to receive the DynaCellect instrument unit (see “Instrument dimensions” ™ page 14) ensuring that there is easy access to the “On/Off” switch and mains IEC connector at the rear of the instrument.
  • Page 29 Chapter 2 Installation and setup Installing the instrument 2. Loosen the screw on the pole adaptor. 3. Place the 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. DynaCellect Magnetic Separation System User Guide ™...
  • Page 30 Chapter 2 Installation and setup Installing the instrument 4. Install both pole extensions with the pole adaptor to the 2 pole bases on the instrument. Turn to tighten. Pole adaptor Pole extension Pole base 5. Place the bag hangers on the pole adaptors. DynaCellect Magnetic Separation System User Guide ™...
  • Page 31 Chapter 2 Installation and setup Installing the instrument 6. To extend the poles, loosen the nut (shown in red circle), pull the pole upwards and tighten the nut. 7. The instrument is installed. DynaCellect Magnetic Separation System User Guide ™ ™...

  • Page 32: Power Instrument "On

    Chapter 2 Installation and setup Power instrument "On" Power instrument "On" 1. Insert the power cord to instrument and a 100-240V outlet. 2. Switch on using the mains IEC switch at the rear side of the instrument Power button 3. The instrument will be initialized by itself, which will take ~90 seconds Power instrument "Off"...

  • Page 33: Chapter 3   Embedded Graphical User Interface (Egui) User Instructions

    Embedded graphical user interface (eGUI) user instructions The embedded graphical user interface (eGUI) is where you control the instrument and user access. Besides installing the Single-Use Kit by hand and adjusting pole height, all instrument actions are managed from the eGUI. Home screen On the home screen the main user interaction points are shown in the following figure.

  • Page 34: User Interface Overview

    Chapter 3 Embedded graphical user interface (eGUI) user instructions User interface overview User interface overview Symbol Function Run Protocol Open and run protocol Create Protocol • Create a new protocol • Create a new protocol from existing protocols Manage protocol • Edit existing protocols •...

  • Page 35: Touch Screen Controls

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Touch screen controls Touch screen controls Button Function Returns to the previous screen Close the current window Go to menu screen Status indicators Button Function Indicates whether a USB device is inserted into the instrument Indicates whether the instrument is connected to wired network...

  • Page 36: Enter Text

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Touch screen controls Enter text When you press a field that requires the input of text, the text editor, as seen in the following figure, opens. Enter a letter Change letter case Close and save Delete Close without saving DynaCellect...

  • Page 37: Enter Numbers

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Connect the instrument to the internet Enter numbers When you press a field that requires a numerical input, the numeric editor, as seen in the following figure, opens. Close without saving Delete Enter a number Close and save Connect the instrument to the internet The instrument can connect to the internet with the Ethernet cable.

  • Page 38: Set Up A Wired Connection

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Connect the instrument to the internet Set up a wired connection Connect one end of an Ethernet cable to the instrument Ethernet port, and the other end to an Ethernet port wall plug (for port location, see “System overview” page 11).
  • Page 39 Chapter 3 Embedded graphical user interface (eGUI) user instructions Connect the instrument to the internet 3. In the System Settings screen, select Instrument settings. 4. In the Instrument Settings screen, select Network configuration. DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 40 Chapter 3 Embedded graphical user interface (eGUI) user instructions Connect the instrument to the internet 5. In the Network Configuration screen, select Edit. 6. In the Network Configuration screen, select a field in the Wired panel. 7. Select a method to enter an IP address. •...

  • Page 41: Create A User Profile On The Instrument

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Create a user profile on the instrument Note: If your instrument is not on a network, you do not need to set the IP address. Ask your system administrator if the IP address is assigned statically or dynamically. For static addresses, you need to know the IP address for the instrument, the subnet mask, and the default gateway.

  • Page 42: Manage User Profiles

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage user profiles Manage user profiles All users can manage their profiles to edit personal folder names, and change PINs by selecting their (Profile) to enter their My Profile page. Users with Administrator profiles (as indicated by an asterisk after their username) also have the ability to manage all user accounts by selecting All profiles after entering their My Profile page.

  • Page 43: Delete A User Profile

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Manual mode Delete a user profile 1. Select All profiles. 2. Select the account to be deleted. 3. Select Delete account. Assign or remove administrator privileges An asterisk appears next to user profiles with administrator privileges. 1.

  • Page 44: Manage Protocols

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 2. Select Cell isolation protocol or Bead removal protocol. 3. Create a desired step (see “Create protocol steps” page 54) and select Run to initate the step. Manage protocols There are different options available for selecting a protocol: •...

  • Page 45: Protocol Parameters

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Select Manage to edit an existing protocol, import a protocol, or export a protocol or review protocol details: 1. Select Manage. 2. Choose either Cell isolation protocol or Bead removal protocol. 3.
  • Page 46 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Study the template protocols from Thermo Fisher Scientific to get a better understanding of how to best design protocols. When creating a protocol from scratch, there are zero pre-made steps, and every single step in the protocol must be programmed.
  • Page 47 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 2. In the Create New Protocol screen, enter Protocol name (white spaces are not allowed), select Select kit (Cell Isolation or Bead Removal). The kit selected will determine whether you get access to the isolation- or bead removal-specific workflow).
  • Page 48 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 4. 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).
  • Page 49 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 1. In the Create New Protocol screen, select Create from existing. 2. Select Cell isolation protocol or Bead removal protocol. DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 50 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 3. In the Isolation Protocol screen, select a protocol under User created or Template. Select Open to proceed. 4. In Protocol name field enter a name for the new protocol. Select Edit sites. DynaCellect Magnetic Separation System User Guide ™...
  • Page 51 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 5. 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.
  • Page 52 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 7. In the Kit and Consumables Volumes screen insert volumes in the different sites (this 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.
  • Page 53 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Since the same protocol may be used repeatedly with different bead batches, the bead calculator is also used in Run Protocol, so that the bead volumes can be updated for each single run. If this level of precision (controlling for ±...

  • Page 54: Create Protocol Steps

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Create protocol steps This is the Create step view, which is where the actual protocol is programmed in a stepwise manner. More details about the different functionalities are shown, see Table 2. Note: At a high-level, there are three parameters that can be set in a step, which are: magnet, rocker, and pump.
  • Page 55 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Table 2 Features of the Create step view  (continued) Feature Details A–K A–K reflect the various liquid and air lines. To make a valid path, one start destination and one end destination must be chosen. Valid fluid paths go via the pump. Pump Flow rates: 1–150 mL/min.
  • Page 56 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Below is the Review screen which shows all steps created in a protocol. The Review screen enables the user to delete, edit, and rename individual steps, duplicate steps and move them in relation to each other (drag and drop), go back to the Create screen, Cancel or Save protocol.
  • Page 57 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Fluid and air movement 1. Go to the Create screen. DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 58 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 2. First select the line you want to transfer fluid (A–I) or air (J–K) from. After selecting the line the fluid is transferred from, the fluid path will be highlighted with the different options fluid can be transferred to.
  • Page 59 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 4. Select under the pump to edit the pump settings. This is done either based on volume or duration. Select Volume and insert a desired volume (mL) and flow rate (mL/min). The duration is a result of the volume and flow rate.
  • Page 60 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 1. Select to activate the bubble sensor. 2. In the state where the bubble sensor is inactive, it will not interfere with pumping. DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 61 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 3. When the bubble sensor is active, the bubble sensor can stop the pump either when it detects absence of liquid, Stop when dry, or when it detects liquid, Stop when wet. 4.
  • Page 62 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Rocker Pump active When the rocker has been activated (On), it can be programmed as shown in the following image. Note: When the pump is active the pump duration dictates the duration of the step and the magnet/rocker activity will continue for the entire step duration.
  • Page 63 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols If the rocker is Off, the angle of the rocker can still be changed. 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. The duration windows are grey, reflecting that the duration cannot currently be altered.
  • Page 64 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Pump inactive When the rocker has been activated (On), it can be programmed as shown in the following image. Now, as the pump is inactive, a duration for the rocker can be set. If the rocker is Off, the angle of the rocker can still be changed.
  • Page 65 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Magnet Without step duration When the magnet is set to On without step duration, the instrument will move to next step after the magnet has been engaged and the rocker has reached the target angle. When the magnet is On, it is engaged, reflected by the magnet upward position.

  • Page 66: Prompts

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols Prompts A prompt can be added as a gatekeeper for the step in question, such as “harvest sample from A for cell count analysis” or “Is bag G empty?”. The prompt needs to be acknowledged before allowing the subsequent step to be initiated.
  • Page 67 Chapter 3 Embedded graphical user interface (eGUI) user instructions Manage protocols 3. The prompt is active 4. When running the protocol the prompt will appear in the end of 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.

  • Page 68: Run Protocol

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol Run protocol 1. From the Home screen, select Run protocol. 2. In the Open Protocols screen, select Cell isolation protocol or Bead removal protocol. DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 69 Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol 3. Select a protocol from User created or Template. 4. Select the protocol you want to run, either a user-created protocol or a template protocol. Select View details to see the details provided for the respective protocols during Create or Manage, if that is necessary to ensure the correct protocol has been selected.
  • Page 70 Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol 5. To start the run setup, select a protocol and then Begin setup. 6. In the Setup screen it is informed that an Cell Isolation Kit is required. DynaCellect Magnetic Separation System User Guide ™...
  • Page 71 Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol 7. In the following screens you can enter information that is unique for every run. This information will be captured in the Summary Report, which can be exported and included as part of an eBatch-record.
  • Page 72 Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol 9. The resulting bead volume is then updated to the pre-defined bead site, and will be captured in the Summary report. 10. The Prepare screen shows how the consumables should be prepared (which bags contain what and how much of the various solutions), and is intended to help get the system ready for the actual run.
  • Page 73 Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol 12. Select Start run to initiate the run. It is also possible to start the protocol from a chosen step. Press Select step, then choose the step you want to start from and select Jump start. DynaCellect Magnetic Separation System User Guide ™...
  • Page 74 Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol 13. Run view 1 of 3, displaying run information. This view is the one with the least amount of details. Swipe to the right to get the alternative view screens, all acting as run “monitors” with differing levels of detail.
  • Page 75 Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol Table 3 Symbols second view screen  (continued) Symbol Description Active bubble sensor Rocker activated Single rocker movement Magnet engaged Magnet disengaged 15. The third view 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.
  • Page 76 Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 77 Chapter 3 Embedded graphical user interface (eGUI) user instructions Run protocol 16. Then, choose the Role of exporter (Administrator, Scientist or Guest), select Export and select to export to USB drive or network drive. 17. In the Report screen, Select Close to get instructions on how to remove the kit from the instrument.

  • Page 78: Pause Protocol

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Pause protocol Pause protocol 1. The protocol can be paused by selecting Pause run on all the three run view screens. The following screen will pop up. Confirm pausing run by selecting Yes. The protocol is now paused, and the timer shows how long the protocol has been paused.

  • Page 79: Skip Step

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Skip step Skip step It is possible to skip steps when a protocol is running. 1. Select Skip step on screen number two or three. DynaCellect Magnetic Separation System User Guide ™ ™...

  • Page 80: Stop Protocol

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Stop protocol 2. The following screen will appear. Select Yes to skip the current step. Stop protocol The protocol can be stopped by selecting Stop run on all the three run view screens. 1.

  • Page 81: Import A Protocol

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Import a protocol 2. The protocol has stopped and 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.
  • Page 82 Chapter 3 Embedded graphical user interface (eGUI) user instructions Import a protocol 1. From the Home screen, select Manage. 2. Select Cell isolation protocol or Bead removal protocol, depending on which protocol that is going to be imported. DynaCellect Magnetic Separation System User Guide ™...

  • Page 83: Export A Protocol

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Export a protocol 3. In the Manage Isolation Protocols screen, select Import. 4. In the Import screen, select the platform to import the protocol from. Export a protocol Protocols can be exported to the following locations: •...
  • Page 84 Chapter 3 Embedded graphical user interface (eGUI) user instructions Export a protocol 1. From the Home screen, select Manage. 2. Select Cell isolation protocol or Bead removal protocol, depending on which protocol that is going to be exported. DynaCellect Magnetic Separation System User Guide ™...
  • Page 85 Chapter 3 Embedded graphical user interface (eGUI) user instructions Export a protocol 3. In the Manage Isolation Protocols screen, select Export. 4. In the Export screen, select the protocols to export. DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 86 Chapter 3 Embedded graphical user interface (eGUI) user instructions Export a protocol 5. In the Export screen, select the location you want to export to (USB drive or network drive). 6. When the export is complete, the following screen will show. DynaCellect Magnetic Separation System User Guide ™...

  • Page 87: Edit Protocols

    Chapter 3 Embedded graphical user interface (eGUI) user instructions Edit protocols Edit protocols 1. To edit an existing protocol, from the Home screen, select Manage. 2. Choose to edit an Cell isolation protocol or Bead removal protocol. DynaCellect Magnetic Separation System User Guide ™...
  • Page 88 Chapter 3 Embedded graphical user interface (eGUI) user instructions Edit protocols 3. In the Manage Isolation Protocols screen, select Edit. 4. Select a protocol and select Edit to proceed. DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 89 Chapter 3 Embedded graphical user interface (eGUI) user instructions Edit protocols 5. The details of the protocol are shown. The name and type of kit cannot be altered when editing a protocol. (If it is desired to change the protocol name, you must create a new protocol from an existing protocol.
  • Page 90 Chapter 3 Embedded graphical user interface (eGUI) user instructions Edit protocols 7. In the Bead location 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).
  • Page 91 Chapter 3 Embedded graphical user interface (eGUI) user instructions Edit protocols 9. Steps can now be edited/duplicated/deleted/added in the review mode. Or 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. DynaCellect Magnetic Separation System User Guide ™...
  • Page 92 Chapter 3 Embedded graphical user interface (eGUI) user instructions Edit protocols 11. Select Save Protocol. 12. As you have edited a protocol the following message will show. Select Yes to save the new changes to the protocol. DynaCellect Magnetic Separation System User Guide ™...

  • Page 93: System Settings

    Chapter 3 Embedded graphical user interface (eGUI) user instructions System settings System settings Software updates Perform software updates via the USB port, located to the right of the eGUI and below the emergency stop button. 1. On the Home screen, select (Menu) 2.
  • Page 94 Chapter 3 Embedded graphical user interface (eGUI) user instructions System settings 3. In the System Settings screen, select Maintenance & service. 4. In the Maintenance & Service screen, select Software update. 5. Insert the USB drive and select the software update file. IMPORTANT! Remember to backup the data before updating the software.
  • Page 95 Chapter 3 Embedded graphical user interface (eGUI) user instructions System settings 6. Wait for the software update process to complete (3 to 5 minutes). DynaCellect Magnetic Separation System User Guide ™ ™...

  • Page 96: Opc-Ua

    Chapter 3 Embedded graphical user interface (eGUI) user instructions OPC-UA OPC-UA An Open Platform Communications - United Architecture (OPC-UA) interface is provided that enables admin users to connect the 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”.

  • Page 97: Chapter 4   Opc-Ua Interface

    OPC-UA interface Introduction There are requirements where the CTS DynaCellect Magnetic Separation System instrument will ™ ™ need to be monitored and controlled by a Distributed Control System (DCS). The Emerson DeltaV ™ system is one of the DCS systems which will be used here to perform these operations targeted for clinical and commercial manufacturing.

  • Page 98: Mes Interface

    Chapter 4 OPC-UA interface MES Interface (continued) Abbreviations Definition Protocol A series of equipment instructions The execution (running) of a protocol, from beginning to end Distributed Control System OPC-UA Open Platform Communications - United Architecture, a machine to machine communication protocol for industrial automation MES Interface A Manufacturing Execution System (MES) interface is provided to enable processing by the DynaCellect...

  • Page 99: Architecture

    Chapter 4 OPC-UA interface MES Interface Architecture The following component diagram describes the communication within subcomponents of DynaCellect instrument and to the external OPC-UA Client (DeltaV system). ™ ™ The Instrument Server will be the main interface performing back end logic to support both eGUI and OPC-UA Server interactions.

  • Page 100: Initial Opc-Ua Setup

    Chapter 4 OPC-UA interface Initial OPC-UA Setup The communication between DynaCellect system and the DeltaV system will be as follows: ™ ™ 1. The DeltaV system will send the commands (Controls) to OPC-UA Server and OPC-UA Server will ™ in turn relay these commands to the Instrument Server. 2.

  • Page 101: Access Methods

    Chapter 4 OPC-UA interface Initial OPC-UA Setup 1. From the Home screen, navigate to Settings and press OPC Mode. 2. Enable OPC Mode, allow control via OPC server, then select Next. Disallow control via OPC server option prevents the OPC server from accepting control functions while still allows sending status information.
  • Page 102 Chapter 4 OPC-UA interface Initial OPC-UA Setup 1. Select Edit port. 2. Key in the port number (default: 4880) and press Enter. Certificate The user will have to perform the following to setup the login credential via SSL certificate. • Import the certificate from the OPC-UA client’s (DeltaV system) trust store ™...
  • Page 103 Chapter 4 OPC-UA interface Initial OPC-UA Setup The sequence diagram below describes the flow for user to retrieve the SSL certificate from the instrument. 1. The instrument server will generate client SSL certificate and add it into OPC server's trust store. 2. The user then exports the OPC-UA client application certification and import it into the OPC server's trust store.
  • Page 104 Chapter 4 OPC-UA interface Initial OPC-UA Setup 1. From the OPC Access Method dialog, select Certificate. 2. Plug in the USB disk with the OPC-UA client certificate into the DynaCellect instrument. ™ 3. Select Import certificate. DynaCellect Magnetic Separation System User Guide ™...
  • Page 105 Chapter 4 OPC-UA interface Initial OPC-UA Setup 4. Select the OPC-UA certificate from the USB drive dialog screen shown in the following image, press Select and wait for the import process to complete. DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 106 Chapter 4 OPC-UA interface Initial OPC-UA Setup 5. Select Export certificate. This will generate a client certificate into the USB drive. The user will then be able to import this into the OPC client’s trust store. 6. Copy the password shown after generating the certificate. This password will be used to authenticate the certificate at the OPC-UA client side.
  • Page 107 Chapter 4 OPC-UA interface Initial OPC-UA Setup The user will have to perform the following steps to setup a username and password credential 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.

  • Page 108: Enable Opc-Ua

    Chapter 4 OPC-UA interface Enable OPC-UA 3. Import OPC-UA client application certificate from USB drive. 4. Import OPC-UA client application certificate from USB drive. 5. Enter 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 ™...
  • Page 109 Chapter 4 OPC-UA interface Enable OPC-UA 1. From Setting menu, press OPC Mode and select Done. 2. OPC mode is enabled and the following dialog is displayed. DynaCellect Magnetic Separation System User Guide ™ ™...

  • Page 110: Import Protocol For Opc-Ua

    Chapter 4 OPC-UA interface Import protocol for OPC-UA Import protocol for OPC-UA The sequence diagram below describes the process of importing a protocol to DynaCellect ™ instrument’s OPC-UA server application. 1. Using the instrument’s eGUI, the user creates and exports the protocol to USB. This will create \DynaCellectProtocols folder in the root directory of the USB disk.
  • Page 111 Chapter 4 OPC-UA interface Import protocol for OPC-UA After the table file is generated and copied in the same folder as the protocol files, the user can proceed to import the protocols using the DynaCellect instrument’s eGUI application. ™ 1. Press Import/Export from the OPC Mode screen. 2.
  • Page 112 Chapter 4 OPC-UA interface Import protocol for OPC-UA 3. Press Import and then press Next in the following screens. DynaCellect Magnetic Separation System User Guide ™ ™...
  • Page 113 Chapter 4 OPC-UA interface Import protocol for OPC-UA 4. Wait for the import process to complete, press Close. DynaCellect Magnetic Separation System User Guide ™ ™...

  • Page 114: Opc-Ua Interface

    Chapter 4 OPC-UA interface OPC-UA interface OPC-UA interface Information model DynaCellect Magnetic Separation System User Guide ™ ™...

  • Page 115: Monitoring

    Chapter 4 OPC-UA interface OPC-UA interface Monitoring Instrument properties Variable Type Access Value/Description InstrumentName String Read The name of the instrument SerialNumber String Read The serial number of the instrument FirmwareVersion String Read The firmware version of the instrument HardwareVersion String Read The hardware version of the instrument ManufacturerName...
  • Page 116 Chapter 4 OPC-UA interface OPC-UA interface Protocol properties Variable Type Access Value/Description ProtocolName String Read The name of the loaded protocol ProtocolLastModUser String Read The last user who modified the protocol ProtocolLastModDate String Read The last modification date of the protocol ProtocolType String Read The protocol type...
  • Page 117 Chapter 4 OPC-UA interface OPC-UA interface (continued) Variable Type Access Value/Description Volume-E UInt32 Read The protocol bag E volume number The protocol bag F volume Volume-F UInt32 Read number Volume-G UInt32 Read The protocol bag G volume number Volume-H UInt32 Read The protocol bag H volume number Volume-I UInt32...

  • Page 118: Controlling

    Chapter 4 OPC-UA interface OPC-UA interface (continued) Variable Type Access Values / Description RunStatus String Read The current run status • Running • Pausing • Paused • Resuming • Aborting • Stopped • End Controlling Method Type Range Access Value/Description SelectedProtocolInde UInt32 1–99 Read/write The selected protocol...

  • Page 119: Chapter 5   Maintenance

    Maintenance The user is responsible for defining and implementing a suitable maintenance schedule based on their specific usage of the DynaCellect instrument. ™ WARNING! Regular maintenance should be scheduled with Thermo Fisher Scientific to ensure correct operation of the instrument. Any modifications, revisions, maintenance or repair to the CTS ™...

  • Page 120: Power And Fuses

    Chapter 5 Maintenance Power and fuses Power and fuses Power supply The instrument power supply is rated to operate with international standard single-phase power. Specification: 85–264 VAC, Frequency 50/60 Hz, 600 Watts. Fuses The power inlet module houses 2 × 10 A cartridge fuses, 5 mm diameter × 20 mm long, time-lag. •...
  • Page 121 Chapter 5 Maintenance Power and fuses 3. Use tweezers or a small flathead screwdriver, to open the cover to expose the fuse housing. 4. Pull out the fuse housing. 5. Remove the fuses located inside the housing to replace with new ones on both sides of the housing.
  • Page 122 Chapter 5 Maintenance Power and fuses 6. Return the fuse housing back 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. DynaCellect Magnetic Separation System User Guide ™...

  • Page 123: Restore Factory Settings (Administrator Profile Only)

    Chapter 5 Maintenance Restore factory settings (Administrator profile only) Restore factory settings (Administrator profile only) 1. Select (Menu) then (Settings). 2. Select Maintenance and & Services and select Restore factory settings and Restore to remove all the data and customized settings and revert to factory settings. All data and settings will be erased once factory settings are restored.

  • Page 124: Repackaging And Storage Instructions

    Chapter 5 Maintenance Repackaging the instrument Repackaging and storage instructions 1. Turn off the main power switch at the rear of the instrument and detach the power cord from the rear of instrument. 2. Place the instrument in the original box including the original packing foam. 3.

  • Page 125: Chapter 6   Basic Instrument Operation

    Basic instrument operation Unpack Single-Use Kits There are two types of single-use kits: • CTS DynaCellect Cell Isolation Kit (Cat. No. A52300) ™ ™ • CTS DynaCellect Bead Removal Kit (Cat. No. A52301) ™ ™ They are packaged in two bags that have both gone through gamma sterilization. DynaCellect Cell Isolation Kit ™...
  • Page 126 Chapter 6 Basic instrument operation Unpack Single-Use Kits 2. Follow the same procedure illustrated in step 1 to remove the 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. DynaCellect Magnetic Separation System User Guide ™...

  • Page 127: Connecting Vessels, Bags And Reagents

    Chapter 6 Basic instrument operation Connecting vessels, bags and reagents 4. Take all tubes out of the catch on the top of the cassette. 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.

  • Page 128: Prepare Consumables For A Run

    Chapter 6 Basic instrument operation Prepare consumables for a run Prepare consumables for a run Example consumable configuration Example consumable configuration for isolation of 400 million target cells and bead removal of 1 L culture Figure 8   Examples of consumable configurations DynaCellect Cell Isolation Kit ™...
  • Page 129 Chapter 6 Basic instrument operation Prepare consumables for a run Table 4   Bags used for the cell isolation configuration Content Bag type Connectors Tube line Volume DPBS/1% HSA 1 L Terumo Spike to female luer B, E 550 mL ™ with 10 cm tube and spike to male luer with 50  cm tube Output 1 L Terumo...

  • Page 130: Bags And Connectors

    Chapter 6 Basic instrument operation Prepare consumables for a run Bags and connectors Note: All preparations of reagent bags with cells/beads/media etc must be prepared in a laminar flow hood to ensure sterility. OpTmizer T-Cell Expansion SFM bag with spike to female luer with 50 cm (19.7") tube. ™...

  • Page 131: Prepare Bags (For Dpbs/1% Hsa, Waste, Output, Cells)

    Chapter 6 Basic instrument operation Prepare consumables for a run Terumo bag for miscellaneous content with spike to female luer with 10 cm (3.94") tube and spike to ™ male luer with 50 cm (19.7") tube. Prepare bags (for DPBS/1% HSA, waste, output, cells) Note: All preparations of reagent bags with cells/beads/media etc must be prepared in a laminar flow hood to ensure sterility.
  • Page 132 Chapter 6 Basic instrument operation Prepare consumables for a run 2. If a bag shall be welded to multiple sites, the bag can be spiked with spike to male luer with 50 cm (19.7") tube to add a weldable tubing. Clamp off integrated tubing to avoid spill. 3.
  • Page 133 Chapter 6 Basic instrument operation Prepare consumables for a run 4. Purge with air to transfer all liquid to the bag. Also, air is added to the bag to avoid creating vacuum and ease draining when running a protocol on the DynaCellect system.

  • Page 134: Prepare Conical Bag (For Bead Input)

    Chapter 6 Basic instrument operation Prepare consumables for a run Prepare conical bag (for bead input) 1. Seal off top left tube to simplify handling. 2. Weld spike to female luer with 50 cm (19.7") tube to the bag input port. The luer-lock replaces the blunt tube end, so that beads can be added via the luer-lock syringe.

  • Page 135: Transfer The Beads To Bag With A Vial Adapter

    Chapter 6 Basic instrument operation Prepare consumables for a run Transfer the beads to bag with a vial adapter Note: All preparations of reagent bags with 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.
  • Page 136 Chapter 6 Basic instrument operation Prepare consumables for a run 3. Connect the vial adapter to the bead vial (after rolling beads for 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. DynaCellect Magnetic Separation System User Guide ™...

  • Page 137: Welding Transfer Bags To Kit

    Chapter 6 Basic instrument operation Prepare consumables for a run 6. Transfer beads to the bag via luer-lock. Purge two times with air to minimize loss. Welding transfer bags to kit 1. Place the Single-Use Kit on one side of the welder and the transfer bags on the other side of the welder.
  • Page 138 Chapter 6 Basic instrument operation Prepare consumables for a run 2. Open the weld by pressing on the tube. Ensure that the weld was successful by pulling on the tubes. 3. Keep clamps on bag side of the weld to keep filled bags clamped after welding. 4.

  • Page 139: Install Cts ™ Dynacellect ™ Cell Isolation Kit On The Instrument

    Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument ™ ™ Install CTS DynaCellect Cell Isolation Kit on the ™ ™ instrument 1. Transport the Single-Use Kit to the instrument using the bag hangers and the cassette handle. 2.
  • Page 140 Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument ™ ™ 3. Fit the cassette onto the fluidic panel. 4. Ensure that both sides of the cassette are secured on the instrument. 5. Route the isolation bag and tube behind the left pole. Unlock the rocker lid from eGUI. DynaCellect Magnetic Separation System User Guide ™...
  • Page 141 Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument ™ ™ 6. Place the bag in the nest with the Gibco logo facing upwards. ™ 7. Close lid (locks automatically). Check that the lid is locked. Secure tube in the tube guide on the rocker.
  • Page 142 Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument ™ ™ 9. Open the pinch valves using the eGUI and manually open the pump lid. Install the tubes into the two pressure sensors, the two bubble sensors, the pump and the pinch valves. 10.
  • Page 143 Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument ™ ™ 11. Install tubes in bubble sensors. 12. Ensure that tube is seated all the way into the recess of the pressure sensors and the bubble sensors. 13.
  • Page 144 Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument ™ ™ 14. Insert the tube into the second pressure sensor (stretch while inserting). 15. Insert the tubes into all pinch valves. 16. The tube holder, the cassette and the pinch valves have letters to ensure correct placing of the tubing.
  • Page 145 Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument ™ ™ 17. When all tubes are installed, straighten tubes and close pinch valves using eGUI. 18. Correct installation of the fluidic panel. DynaCellect Magnetic Separation System User Guide ™...
  • Page 146 Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument ™ ™ 19. Raise poles to straighten out tubes to ensure no kinks are present on the tubes. 20. Remove/open all clamps on the bags. DynaCellect Magnetic Separation System User Guide ™...
  • Page 147 Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument ™ ™ 21. Press on the tubing where the clamp was to ensure no kinks on tubes are present. 22. The system is now ready to run. DynaCellect Magnetic Separation System User Guide ™...

  • Page 148: Install Cts ™ Dynacellect ™ Bead Removal Kit On The Instrument

    Chapter 6 Basic instrument operation Install CTS DynaCellect Bead Removal Kit on the instrument ™ ™ CAUTION! The Single-Use Kit has been designed exclusively for use with the DynaCellect ™ instrument and includes several features to enable fast, error-free loading by the user. It is the responsibility of the user to ensure correct assembly and loading of the Single-Use Kit prior to initiating an instrument protocol.
  • Page 149 Chapter 6 Basic instrument operation Install CTS DynaCellect Bead Removal Kit on the instrument ™ ™ 3. Close the lid and secure the tubes in the tube guide. 4. Additionally, the CTS DynaCellect Bead Removal Kit has 4 input/output lines (while the isolation ™...

  • Page 150: Initiate A Protocol

    Chapter 6 Basic instrument operation Install CTS DynaCellect Bead Removal Kit on the instrument ™ ™ 5. The system is ready to run. Initiate a protocol CAUTION! Manual clamps are used on input and output lines on the Single-Use Kits to prevent fluid movement until the instrument Pinch Valves are engaged.

  • Page 151: Isolation Protocol Overview

    Chapter 6 Basic instrument operation Isolation protocol overview Isolation protocol overview High-level overview of isolation protocol with CTS Dynabeads CD3/CD28. ™ ™ 1. Inflate and prime the isolation bag. a. Add air to the isolation bag to inflate it and enable mixing. b.

  • Page 152: Remove Single-Use Kit

    Chapter 6 Basic instrument operation Remove Single-Use Kit 3. Wash the bead removal bag with wash buffer to transfer the remaining cells in the bead removal bag to the output bag. 4. Add air to the bead removal bag to push the remaining liquid and cells in the bead removal bag to the output bag.
  • Page 153 Chapter 6 Basic instrument operation Remove Single-Use Kit 3. Manually open the pump lid and remove the tubing from the pump, the pinch valves, the pressure sensors and the bubble sensors. 4. From the Home screen, select Unlock rocker lid while pressing down the lid. Remove reaction bag from the nest.

  • Page 154: Aseptic Disconnection Of The Kit Components

    Chapter 6 Basic instrument operation Remove Single-Use Kit 5. Loosen the tube holder and the cassette by pressing the clips on both sides of the cassette. The kit can now be removed from the instrument. 6. Close all pinch valves after the kit is removed. Aseptic disconnection of the kit components If not done prior to Single-Use Kit removal from the instrument: •...

  • Page 155: Chapter 7   Safety Instructions

    Safety instructions Labels Emergency procedures This section describes the process for initiating an emergency shutdown and the consequence of a power failure. Instrument emergency stop event The instrument will automatically stop a running protocol if: • The emergency stop button is activated. Safety relay contacts welded or intermittent •...

  • Page 156: Emergency Shut Down

    Chapter 7 Safety instructions Emergency procedures Instrument stop events are included for the safety of the operator and instrument. Where possible, warnings of problematic settings will be reported by the instrument if they can be identified before a stop is triggered. Emergency shut down The instrument can be shut down by the user in the following ways: •...

  • Page 157: Protocol Recovery Process

    Chapter 7 Safety instructions Emergency procedures Protocol recovery process Once the conditions causing the fault have been addressed it may be possible to restart a protocol from a specific protocol step. Note: Unless there has been a breach of the closed fluidic system, the reagents will have been retained in the system and are potentially recoverable.

  • Page 158: Warnings And Precautions

    Chapter 7 Safety instructions Warnings and precautions Warnings and precautions Warnings WARNING! · The DynaCellect instrument is capable of producing liquid pressures up to 200 kPa if the flow is ™ restricted. It is the user’s responsibility to ensure the volume of liquid pumped to any connected vessel does not exceed the rated volume of that vessel.

  • Page 159: Cautions

    Chapter 7 Safety instructions Warnings and precautions Cautions CAUTION! · The DynaCellect system shall be used exclusively with the Single-Use Kits. The kits are for ™ single use only and should be used within their stated expiration date. The user is responsible for appropriate storage, handling and disposal of the Single-Use Kits.

  • Page 160: Appendix A   Troubleshooting

    Troubleshooting WARNING! Before performing any of the procedures described in this section, you must first read and understand all contents in prior sections of the user guide. Please ensure that you contact an approved Thermo Fisher Scientific representative if there is any doubt as to the use or maintenance of the CTS DynaCellect Magnetic Separation System.
  • Page 161 Appendix A Troubleshooting Warnings and precautions Observation Possible cause Recommended action Pressure sensor Occluded tubes Ensure tubes are not occluded by clamps, welds or otherwise pinched tubings Rocker lid not opening Too high pressure in reaction Open pinch valves and pump lid to release bag in the nest pressure.

  • Page 162: Appendix B   Error Lists

    Error lists Definitions/Acronyms Acronyms Definitions eGUI Embedded Graphical User Interface System Instrument Server System Motion Control Board BLDC Brushless DC Motor Control Valve Control Board Code Error code or id Message Error message shown in graphical user interface Context State when the error condition may or will occur •...

  • Page 163: System Error List

    Appendix B Error lists System error list System error list Code Message Context Description Recovery action Unknown Startup Error was detected Export service logs 0x8855 initialization error during instrument and send to tech startup support for further assistance 0x8857 Unable to decrypt Upgrade Unable to decrypt Export service logs...
  • Page 164 Appendix B Error lists System error list (continued) Code Message Context Description Recovery action 0x8871 Emergency stop is Idle Emergency stop Reset emergency activated was activated stop switch and Recipe perform recovery Manual using the reset button in the user interface prompt dialog after releasing the switch 0x8810 Rocker lid is not...
  • Page 165 Appendix B Error lists System error list (continued) Code Message Context Description Recovery action 0x8816 Rocker guard is not Recipe Rocker motor guard Export service logs closed is not installed and send to tech when starting a run support for further assistance •...

  • Page 166: Bldc Error List

    Appendix B Error lists BLDC error list BLDC error list Code Message Context Description Recovery Action • Move rocker Rocker motion Recipe Rocker motion 0x8061 back to home timeout failed to reach its Manual using manual target within the mode time limit •...

  • Page 167: Vcb Error List

    Appendix B Error lists VCB error list VCB error list Code Message Context Description Recovery action • Pressure • Check Single- Pressure sensor Recipe 0x801C exceeded Use Kit tube threshold exceeded threshold paths for during recipe blockage • If it happens • Run is aborted before a run, re-insert tube by stretching...
  • Page 168 Appendix B Error lists VCB error list (continued) Code Message Context Description Recovery action 0x8102 Pinch valve B failed Manual Pinch valve B Export service logs to open position sensor and send to tech Recipe failed to detect support for further open state assistance 0x8103 Pinch valve C failed...
  • Page 169 Appendix B Error lists VCB error list (continued) Code Message Context Description Recovery action 0x8201 Pinch valve A failed Manual Pinch valve A Export service logs to close position sensor and send to tech Recipe failed to detect support for further close state assistance 0x8202 Pinch valve B failed...
  • Page 170 Appendix B Error lists VCB error list (continued) Code Message Context Description Recovery action 0x820B Pinch valve K failed Manual Pinch valve K Export service logs to close position sensor and send to tech Recipe failed to detect support for further close state assistance 0x8850 Subsystem module...

  • Page 171: Mcb Error List

    Appendix B Error lists MCB error list MCB error list Code Message Context Description Recovery Action • Power cycle The motor driver Recipe Motor driver fault 0x8106 instrument encountered a fault error Manual condition • If error persists, export service logs and send to tech support for further assistance...
  • Page 172 Appendix B Error lists MCB error list (continued) Code Message Context Description Recovery Action 0x8806 Bag lid height Recipe Bag lid height motor Export service logs motors failed to retract position and send to tech Manual retract sensor failed to support for further activate after retract assistance command...

  • Page 173: Appendix C   Recommended Instrument Settings

    Recommended instrument settings About instrument Select (Menu), (Settings), 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. DynaCellect Magnetic Separation System User Guide ™...

  • Page 174: Instrument Settings (Administrator Only)

    Appendix C Recommended instrument settings Instrument settings (administrator only) Instrument settings (administrator only) Select Instrument Settings to set the following instrument parameters. • Instrument name: – Select the Instrument name field to activate the text editor. Enter up to 32 alphanumeric characters to identify the instrument. Note: The instrument name cannot have spaces.
  • Page 175 Appendix C Recommended instrument settings Instrument settings (administrator only) • Sleep mode: – Use the Off and On toggle to disable or enable sleep mode. In the 'On' mode, select the Edit Time field to activate the numeric editor to set the time after which the instrument will go from idle mode to standby mode.

  • Page 176: Maintenance And Service

    Appendix C Recommended instrument settings Maintenance and service Maintenance and service Select Maintenance & Service to set the following instrument parameters. • (Administrator only) Select Software update to update the System software. See page 93 instructions on updating the software. • Select Export service logs to export the instrument service logs to a USB memory device. Insert the USB memory device into the USB port before using this feature.

  • Page 177: Run History

    Appendix C Recommended instrument settings Run history Run history Select Run History to display the entire list of runs performed by the instrument. • Select a particular file to view the details of that run. DynaCellect Magnetic Separation System User Guide ™ ™...

  • Page 178: Appendix D   Related Products

    Related products Additional products The following products are for use with the CTS DynaCellect Magnetic Separation System and are ™ ™ available separately. Unless otherwise indicated, all materials are available through thermofisher.com. Amount Cat. No. Reagents Dynabeads CD3/CD28 10 mL 40203D ™...
  • Page 179 Appendix D Related products Additional products (continued) Amount Cat. No. Consumables DynaCellect Cell Isolation 1 kit A52300 ™ ™ DynaCellect Bead 1 kit A52301 ™ ™ Removal Kit Teruflex transfer bags 1 L BB*T100BM (Terumo BCT) ™ Teruflex transfer bags 150 mL BB*T015CM (Terumo BCT) ™ V-shaped bags for bead and/or cell input: Cryostore 400 Conical EVA...

  • Page 180: Appendix E   Safety

    Safety WARNING! GENERAL SAFETY. Using this product in a manner not specified in the user documentation may result in personal injury or damage to the instrument or device. Ensure that anyone using this product has received instructions in general safety practices for laboratories and the safety information provided in this document.

  • Page 181: Safety Labels

    Appendix E Safety Symbols on this instrument Safety labels Symbol Description CAUTION! BIOHAZARD. Biological samples such as tissues, body fluids, infectious agents, and blood of humans and other animals have the potential to transmit infectious diseases. Conduct all work in properly equipped facilities with the appropriate safety equipment (for example, physical containment devices).

  • Page 182: Location Of Safety Labels

    Appendix E Safety Symbols on this instrument Location of safety labels Label and location Figure 11   Front view, lid open Figure 12   Front view, lid closed Figure 13   Rear view DynaCellect Magnetic Separation System User Guide ™ ™...

  • Page 183: Safety Compliance

    Appendix E Safety Symbols on this instrument Safety compliance The instrument design and manufacture complies with the following standards and requirements for safety, electromagnetic compatibility, and Environmental WEEE. Reference Description EU Directive 2014/35/EU European Union “Low Voltage Directive” IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use –...

  • Page 184: Symboles D'information

    Appendix E Safety Symbols on this instrument (continued) Symbol and description This product conforms to UL 61010-1, CAN/CSA C22.2 No.61010-1 “Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part l: General Requirements.” Instruments bearing the UL symbol are certified by Underwriters Laboratories to be in conformance with the applicable safety standard for the US and Canada.

  • Page 185: Instrument Safety

    Appendix E Safety Instrument safety (continued) Symbol and description Ce produit est conforme à UL 61010-1, CAN/CSA C22.2 No.61010-1 «Exigences de sécurité pour l’équipement électrique pour la mesure, le contrôle et l’utilisation en laboratoire, Partie l : Généralité Les exigences.» Les instruments portant le symbole UL sont certifiés par Underwriters Laboratories conforme à...

  • Page 186: Physical Injury

    Appendix E Safety Instrument safety Physical injury CAUTION! Moving and Lifting Injury. The instrument is to be moved and positioned only by the personnel or vendor specified in the applicable site preparation guide. Improper lifting can cause painful and permanent back injury. Things to consider before lifting or moving the instrument or accessories: ·...

  • Page 187: Electrical Safety

    Appendix E Safety Instrument safety 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 fire.

  • Page 188: Instrument Component And Accessory Disposal

    Appendix E Safety Environmental requirements Instrument component and accessory disposal 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. Environmental requirements WARNING! The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 22 class A).

  • Page 189: Emc Compliance

    Appendix E Safety Electromagnetic compatibility (EMC) standards 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...

  • Page 190: Environmental Design Standards

    Appendix E Safety Environmental design standards Environmental design standards Reference Description Directive 2012/19/EU European Union “WEEE Directive”—Waste electrical and electronic equipment Directive 2011/65/EU European Union “RoHS Directive”—Restriction of hazardous substances in electrical and electronic equipment SJ/T 11364-2014 “China RoHS” Standard—Marking for the Restricted Use of Hazardous Substances in Electronic and Electrical Products For instrument specific certificates, visit our customer resource page at www.thermofisher.com/us/en/home/technical-resources/rohs-certificates.html.

  • Page 191: Magnet Safety

    Appendix E Safety Magnet Safety • Use suitable overvoltage protection to ensure that no overvoltage (such as that caused by a bolt of lightning) can reach the product. Otherwise, the person operating the product will be exposed to the danger of an electric shock. •...

  • Page 192: Chemical Safety

    Appendix E Safety Chemical safety Chemical safety WARNING! GENERAL CHEMICAL HANDLING. To minimize hazards, ensure laboratory personnel read and practice the general safety guidelines for chemical usage, storage, and waste provided below. Consult the relevant SDS for specific precautions and instructions: · Read and understand the Safety Data Sheets (SDSs) provided by the chemical manufacturer before you store, handle, or work with any chemicals or hazardous materials.

  • Page 193: Biological Hazard Safety

    Appendix E Safety Biological hazard safety Biological hazard safety WARNING! Potential Biohazard. Depending on the samples used on this instrument, the surface may be considered a biohazard. Use appropriate decontamination methods when working with biohazards. WARNING! BIOHAZARD. Biological samples such as tissues, body fluids, infectious agents, and blood of humans and other animals have the potential to transmit infectious diseases.

  • Page 194: Safety Precautions

    Appendix E Safety Service personnel Safety precautions Risk of contamination Symbol Description • Wear Personal Protective Equipment (PPE) and do not contact spilled fluids directly. If necessary, do the decontamination procedure before you do servicing. • Biological samples run on the instrument may contain potentially infectious diseases.

  • Page 195: Return To Use

    Appendix E Safety Service personnel Electrostatic discharge protection Symbol Description • Use ESD wrist-straps, shoes, or ESD heel grounder and keep ESD-sensitive parts in their 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.

  • Page 196: Appendix F   Documentation And Support

    Documentation and support Customer and technical support Visit thermofisher.com/support for the latest service and support information. • Worldwide contact telephone numbers • Product support information – Product FAQs – Software, patches, and updates – Training for many applications and instruments •...
  • Page 198 CTS DynaCellect 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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