Thermo Scientific gibco CTS DynaCellect Magnetic Separation... User manual

For Research Use or Manufacturing 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

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
A.0 13 October 2022 New document for CTS™DynaCellect™Magnetic Separation System.
The information in this guide is subject to change without notice.
DISCLAIMER: 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 and conditions of all applicable Limited Use Label Licenses.
TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
©2022 Thermo Fisher Scientific Inc. All rights reserved.

Contents
■CHAPTER1Productinformation .................................................. 8
Productdescription ............................................................. 8
Single-UseKits ............................................................. 9
Storage .................................................................... 9
Instrument features .............................................................. 9
Contents ...................................................................... 10
Required materials notsupplied ................................................. 10
Embedded Graphical User Interface (eGUI) features ................................ 10
Process developmentmode ................................................ 10
Clinical manufacturingmode ................................................ 11
System overview ............................................................... 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" ......................................................... 32
Power instrument"O" ......................................................... 32
CTS™DynaCellect™Magnetic Separation System User Guide 3

■CHAPTER3Embedded graphical user interface (eGUI) userinstructions ... 33
Home screen .................................................................. 33
User interface overview ......................................................... 34
Touch screen controls .......................................................... 35
Status indicators .......................................................... 35
Enter text ................................................................. 36
Enternumbers ............................................................ 37
Connect the instrument to the internet ............................................ 37
Set up a wiredconnection .................................................. 38
Create a user profile on theinstrument ............................................ 41
Manage userprofiles ........................................................... 42
Change a userPIN ......................................................... 42
Delete a userPIN .......................................................... 42
Add a userprofile .......................................................... 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
Introduction ................................................................... 97
Definitions .................................................................... 97
MES Interface ................................................................. 98
Background ............................................................... 98
Architecture ............................................................... 99
Initial OPC-UASetup .......................................................... 100
AccessMethods ......................................................... 101
Contents
4CTS™DynaCellect™Magnetic Separation System User Guide

Enable OPC-UA .............................................................. 108
Import protocol for OPC-UA .................................................... 110
OPC-UA interface ............................................................. 114
Informationmodel ........................................................ 114
Monitoring ............................................................... 115
Controlling ............................................................... 118
■CHAPTER5Maintenance ....................................................... 119
Cleaning and maintenance ..................................................... 119
Power andfuses .............................................................. 120
Powersupply ............................................................ 120
Fuses ................................................................... 120
Restore factory settings (Administrator profileonly) ................................ 123
Repackaging theinstrument .................................................... 123
Repackaging and storageinstructions ....................................... 124
■CHAPTER6Basic instrument operation ....................................... 125
Unpack Single-UseKits ....................................................... 125
Connecting vessels, bags 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instrument .................... 148
Initiate a protocol ......................................................... 150
Isolation protocol overview ..................................................... 151
Bead removal protocol overview ................................................ 151
Remove Single-UseKit ........................................................ 152
Aseptic disconnection of the kitcomponents ................................. 154
Contents
CTS™DynaCellect™Magnetic Separation System User Guide 5

■CHAPTER7Safetyinstructions ................................................ 155
Labels ....................................................................... 155
Emergency procedures ........................................................ 155
Instrument emergency stopevent .......................................... 155
Emergency shutdown .................................................... 156
Restart after shutdown ................................................... 156
Protocol recovery process ................................................. 157
Warnings and precautions ..................................................... 158
Warnings ................................................................ 158
Cautions ................................................................ 159
■APPENDIXATroubleshooting .................................................. 160
■APPENDIXBErrorlists .......................................................... 162
Definitions/Acronyms .......................................................... 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 ............................................................. 181
Location of safetylabels ................................................... 182
Safetycompliance ........................................................ 183
Contents
6CTS™DynaCellect™Magnetic Separation System User Guide

Informationalsymbols ..................................................... 183
Symbolesd’information ................................................... 184
Instrumentsafety ............................................................. 185
General ................................................................. 185
Physical injury ............................................................ 186
Electricalsafety .......................................................... 187
Cleaning anddecontamination ............................................. 187
Instrument component and accessorydisposal .............................. 188
Environmental requirements .................................................... 188
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™DynaCellect™Magnetic Separation System User Guide 7

Product information
IMPORTANT! Before using this product, read and understand the information in the “Safety” appendix
in this document.
Product description
The Gibco™CTS™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. The key feature of the instrument is an automated magnet. The
magnet is 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 manufacturing. The closed and automated configuration minimize failures in manufacturing,
oering operator independent results and reduced contamination, while providing increased precision
and scalability.
1
8CTS™DynaCellect™Magnetic Separation System User Guide

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. Each kit has input/output sterile weldable tubes for flexible setup configurations. See
“CTS™DynaCellect™Single-Use Kit schematic” on page17.
Storage
Store at ambient temperature. Storage at this temperature does not lead to decrease in magnetism.
Protect 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
•Leakage sensor
•Lid sensor
•HEPA filter
•2Bag hangers
•2 Pole extensions
•2 Pole adaptors
•3 USB ports
–USB port ready for barcode scanner
•Ethernet port
•Power inlet
•Power switch
Chapter1Product information
Instrument features 1
CTS™DynaCellect™Magnetic Separation System User Guide 9

Contents
Table1CTS™DynaCellect™Magnetic Separation System (Cat.No.A55867)
Component Quantity
CTS™DynaCellect™Magnetic Separation System 1
Power cord 1
Ethernet cable 1
Pole extension 2
Bag hanger 2
Pole adaptor 2
Quick reference guide 1
Installation guide 1
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.
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: engaged/disengaged
–Pinch valves: open/closed
–Pump speed: 10–150mL/min
–Pump: specified volume or duration
Chapter1Product information
Contents
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10 CTS™DynaCellect™Magnetic Separation System User Guide