cytiva Sefia S-2000 User manual

Sefia S-2000 cell processing
instrument
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 7
2 Safety instructions ............................................................................................. 8
2.1 Safety precautions ........................................................................................................................................ 9
2.2 Symbols and abbreviations ........................................................................................................................ 13
2.3 Emergency procedures ............................................................................................................................... 17
3 System description ............................................................................................ 20
3.1 Description of the Sefia S-2000 instrument ........................................................................................ 21
3.2 Touch screen user interface ...................................................................................................................... 27
3.3 Using the Sefia instrument in regulated environments .................................................................. 29
3.4 System log ........................................................................................................................................................ 31
3.5 Data privacy and security ........................................................................................................................... 33
3.6 Applications and processing kits ............................................................................................................. 35
3.7 Accessories ...................................................................................................................................................... 37
3.7.1 Accessories for processing kits .............................................................................................................. 38
3.7.2 Peripherals ...................................................................................................................................................... 40
4 Installation .......................................................................................................... 42
4.1 Safety precautions ........................................................................................................................................ 43
4.2 Site environmental requirements ........................................................................................................... 44
4.3 Moving the Sefia instrument ..................................................................................................................... 45
4.4 Electrical connections ................................................................................................................................. 47
4.5 Installing an application .............................................................................................................................. 50
5 Preparation ......................................................................................................... 54
5.1 Managing users, for Administrators ....................................................................................................... 55
5.1.1 User roles ......................................................................................................................................................... 56
5.1.2 User authentication .................................................................................................................................... 59
5.1.3 Create and edit users .................................................................................................................................. 62
5.2 Reset passwords after BPAS upgrade .................................................................................................... 68
5.3 Editing user details, for Operators .......................................................................................................... 72
5.4 Connecting the Sefia instrument to Chronicle automation software ....................................... 76
5.5 Connecting to Active Directory ................................................................................................................ 79
5.6 Installing a processing kit, important instructions ........................................................................... 85
6 Operation ............................................................................................................ 87
6.1 Start-up and shutdown ................................................................................................................................ 88
6.2 Reports and log files ...................................................................................................................................... 94
6.3 Working with the System log ..................................................................................................................... 96
6.4 Changing general settings ......................................................................................................................... 98
6.5 Setting up application parameters ......................................................................................................... 103
6.6 Setting up traceability .................................................................................................................................. 112
Table of Contents
2 Sefia S-2000 Operating Instructions 29315810 AE

6.7 Working with Chronicle automation software ................................................................................... 120
6.7.1 Importing and duplicating parameters from Chronicle ............................................................... 121
6.7.2 Synchronizing application parameters with Chronicle automation software ................... 127
6.7.3 Monitoring applications from Chronicle automation software ................................................ 129
6.7.4 Exporting historical data to Chronicle ................................................................................................. 131
6.8 Mix Mode stand-alone application ........................................................................................................ 132
7 Maintenance ....................................................................................................... 136
7.1 Introduction to maintenance .................................................................................................................... 137
7.2 Cleaning ............................................................................................................................................................ 138
7.3 Cleaning before planned service ............................................................................................................. 139
8 Troubleshooting ................................................................................................. 140
8.1 General troubleshooting ............................................................................................................................. 141
8.2 Warning messages ........................................................................................................................................ 146
8.3 Error messages ............................................................................................................................................... 148
8.3.1 Error messages from the Sefia instrument ....................................................................................... 149
8.4 Purge mode ...................................................................................................................................................... 158
8.5 Manual purge ................................................................................................................................................... 161
8.6 How to get help ............................................................................................................................................... 164
9 Reference information ....................................................................................... 165
9.1 Get Help ............................................................................................................................................................. 166
9.2 Technical specifications .............................................................................................................................. 168
9.3 Recycling information .................................................................................................................................. 170
9.4 Regulatory information ............................................................................................................................... 171
9.4.1 Contact information .................................................................................................................................... 172
9.4.2 European Union and European Economic Area .............................................................................. 173
9.4.3 Great Britain ................................................................................................................................................... 174
9.4.4 Eurasian Economic Union
Евразийский экономический союз ................................................................................................... 175
9.4.5 Regulations for North America ............................................................................................................... 177
9.4.6 Regulatory statements .............................................................................................................................. 178
9.4.7 Declaration of Hazardous Substances (DoHS) ................................................................................ 179
9.5 Health and Safety Declaration Form ...................................................................................................... 184
Table of Contents
Sefia S-2000 Operating Instructions 29315810 AE 3

1 Introduction
About this chapter
This chapter contains important user information that you must read before operating
the Sefia™ S-2000 cell processing instrument, and information about the user docu-
mentation.
In this chapter
Section See page
1.1 Important user information 5
1.2 About this manual 6
1.3 Associated documentation 7
1 Introduction
4 Sefia S-2000 Operating Instructions 29315810 AE

1.1 Important user information
Read this before operating the
product
All users must read the entire Operating Instructions before installing, oper-
ating or maintaining the product.
Always keep the Operating Instructions at hand when operating the product.
Do not operate the product in any other way than described in the user documenta-
tion. If you do, you may be exposed to hazards that can lead to personal injury and you
may cause damage to the cells or the cell processing equipment.
In addition, all users must read the Operator Manual for the specific application, and
the Instructions for Use for the cell processing kit, before operating the system.
Intended use of the product
The Sefia cell processing system is an automated, functionally-closed platform devel-
oped for cell processing when manufacturing cellular therapy products. It combines
the Sefia instrument exclusively with dedicated software applications and Sefia cell
processing kits to process cellular products. The Sefia cell processing system allows for
versatile combinations of multiple processing steps, including and not limited to
concentration, enrichment, washing, incubation, isolation, harvesting, and final formu-
lation under optional regulated temperatures and mixing.
Use this system for investigational use only, which is limited to advance regulatory
clearance or approval, under the sole responsibility of the user.
Use the Sefia instrument only with the correct combination of Sefia software applica-
tion and cell processing kits.
The Sefia cell processing system is intended for research or cellular product manufac-
turing use in a GMP environment.
The Sefia cell processing system shall not be used in clinical procedures, or for diag-
nostic purposes.
Prerequisites
In order to operate the Sefia instrument in the way it is intended:
•The user must have a general understanding of cell processing, and knowledge
about local practices for biosafety.
•The user must read and understand the Safety instructions chapter in this manual.
•The Sefia instrument must be installed and verified by a Service Engineer or Field
Application Specialist from the manufacturer.
1 Introduction
1.1 Important user information
Sefia S-2000 Operating Instructions 29315810 AE 5

1.2 About this manual
Purpose of this manual
The Operating Instructions provides you with the information needed to install, operate
and maintain the Sefia S-2000 cell processing instrument in a safe way.
Scope of this manual
This manual covers the Sefia S-2000 cell processing instrument and embedded soft-
ware only. The manual covers BPAS version 2.0 and higher.
See the separate Operator Manual supplied with the application for instructions on
how to install a cell processing kit and perform cell separation with the Sefia S-2000
cell processing instrument.
The Sefia S-2000 cell processing instrument is also referred to as the Sefia instrument.
The Sefia S-2000 cell processing instrument, together with cell processing kits and
application software, are referred to as the Sefia cell processing system.
Typographical conventions
Software items are identified in the text by bold italic text.
Hardware items are identified in the text by bold text.
In electronic format, references in italics are clickable hyperlinks.
Notes and tips
Note: A note is used to indicate information that is important for trouble-free and
optimal use of the product.
Tip: A tip contains useful information that can improve or optimize your proce-
dures.
1 Introduction
1.2 About this manual
6 Sefia S-2000 Operating Instructions 29315810 AE

1.3 Associated documentation
User documentation for Sefia S-2000
The user documentation is listed in the table below.
English and translated versions of the Operating Instructions are provided on the USB
flash drive located in the instrument box. The Privacy and Security Manual is also
provided on the USB flash drive.
Documentation Main Contents
Sefia S-2000 cell processing instrument
Operating Instructions
Instructions needed to prepare and
operate the Sefia instrument in a
correct and safe way.
System overview, site requirements,
and instructions for moving the system
within the same building.
Instructions for basic maintenance and
troubleshooting.
Sefia S-2000 cell processing instrument
Privacy and Security Manual
Privacy and Security considerations of
the use of the Sefia instrument with
BPAS 2.0 .
Application Operator Manual for each
application available for use with the
Sefia S-2000 cell processing instrument
Information needed to run the applica-
tion on the Sefia instrument.
1 Introduction
1.3 Associated documentation
Sefia S-2000 Operating Instructions 29315810 AE 7

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to the
equipment.
In this chapter
Section See page
2.1 Safety precautions 9
2.2 Symbols and abbreviations 13
2.3 Emergency procedures 17
2 Safety instructions
8 Sefia S-2000 Operating Instructions 29315810 AE

2.1 Safety precautions
Introduction
Follow the instructions to avoid injury to the operator, or damage to the equipment or
the cell product processed by the equipment.
Before installing, operating or maintaining the system, you must be aware of the
hazards described in this manual.
Definitions
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
WARNING
WARNING indicates a hazardous situation which, if not avoided,
could result in death or serious injury. It is important not to proceed
until all stated conditions are met and clearly understood.
CAUTION
CAUTION indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury. It is important not to
proceed until all stated conditions are met and clearly understood.
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
General precautions
WARNING
Follow the general precautions below.
•Read all instructions before use.
•Contact a Cytiva representative if you are unsure about any aspect of using the
Sefia S-2000 instrument.
•Only trained users should operate the system to ensure safe and effective use.
2 Safety instructions
2.1 Safety precautions
Sefia S-2000 Operating Instructions 29315810 AE 9

•Only approved technicians should modify, revise, maintain, or repair the Sefia
S-2000 instrument. The machine and the disposables are not designed for any
modification by end users or third parties.
•Always use appropriate Personal Protective Equipment (PPE) during operation and
maintenance of this product.
•Check that all equipment functions safely and is in proper working condition before
use.
•Only use the equipment for its intended function, otherwise performance and safety
may be impaired.
•Any connection to the single use kit must be performed under aseptic conditions
(see the application Operator Manual).
•Sefia cell processing kits are sterilized with Ethylene Oxide (EO) and anaphylactic
reactions can occur. Make sure that patients are not hypersensitive to EO before
receiving (any) product processed with Sefia cell processing kits.
Installation and transport
WARNING
Follow the precautions below during installation and transport.
•Keep upright during transport.
•If moving the instrument to another location, it is the laboratory manager's respon-
sibility to make sure it is installed correctly.
•Due to the weight, two people are required to lift and move the instrument in a safe
way.
•Connect the unit to a grounded power supply.
•Connect all equipment to an uninterruptible power supply (UPS).
•Only use the original and certified power supply cable. Do not use adapters or exten-
sion cords.
•Ensure the power switch at the back and any plugs on the instrument are easily
accessible.
•In case of an interruption caused by a power supply failure, or a mechanical inter-
ruption, the instrument will not automatically restart to complete the interrupted
procedure.
Do not expose the instrument to:
•Direct sunlight or strong light sources.
•Liquids or corrosive substances.
•Physical shocks or vibrations.
•Heavy weights.
•Equipment that contains magnets or generates magnetic or electromagnetic fields.
This includes devices such as mobile phones.
2 Safety instructions
2.1 Safety precautions
10 Sefia S-2000 Operating Instructions 29315810 AE

Operation
WARNING
Follow the precautions below when operating the equipment.
•Operate equipment on a flat, stable, horizontal, and clean surface.
•Ensure an open environment with sufficient ventilation.
Single-use cell processing kits
WARNING
Follow the precautions below when handling single-use kits.
•Only use Sefia cell processing kits supplied by the manufacturer, in combination
with the Sefia S-2000 instrument. The processing kits are supplied sterile and for
single-use only.
•Treat the used Processing Kit as biohazardous waste and follow local regulations for
disposal of the kit.
•The customer is responsible for any consequences of using any kit other than those
specified in this document
Cellular product manipulation
WARNING
Follow the precautions below when manipulating cellular products.
•If any spillage or leakage occurs, discard the product. Follow your internally vali-
dated Standard Operating Procedures (SOP) to discard any waste.
•Wear gloves and protective clothing at all times.
Peripherals
WARNING
Follow the precautions below when using peripherals with the
product.
•Do not direct the barcode reader at eyes.
2 Safety instructions
2.1 Safety precautions
Sefia S-2000 Operating Instructions 29315810 AE 11

•Only use printers, barcode readers, USB flash drives, and USB WiFi adapters
supplied by the manufacturer.
•Ensure that generated barcodes are compatible with the system.
•Read all user manuals for any additional connected equipment before use, for
example, printers, power supply, etc.
•Clean printers, barcode readers, USB flash drives, USB WiFi adapters, and associ-
ated power cables with an anti-static cloth and antibacterial solution (such as Meli-
septol™) to disinfect surfaces.
USB flash drive
WARNING
Follow the precautions below when using a USB flash drive.
•Do not use the supplied USB flash drives for any use other than with the Sefia S-2000
instrument.
•When transferring files from a computer to the USB flash drive, scan it with anti-
virus software prior to inserting it into the instrument.
•Only use one USB flash drive at a time with the Sefia S-2000 instrument.
•Contact Cytiva if you need to re-install an application, see Contact information for
support, on page 172.
2 Safety instructions
2.1 Safety precautions
12 Sefia S-2000 Operating Instructions 29315810 AE

2.2 Symbols and abbreviations
Introduction
This section describes the information on the system label and other safety labels that
are attached to the product.
System label
The system label is located on the back of the instrument. The system label identifies
the product and shows electrical data, regulatory compliance, and warning symbols.
The following symbols may be present on the on the system label, or on the box:
Symbol / text Description
Serial number (XXXX.YYYY).
Product code.
Month (MM) and Year (YYYY) of manufacture.
Warning! Read the user documentation before using the
system. Do not open any covers or replace parts unless
specifically stated in the user documentation.
Supply voltage Supply voltage (V).
Alternating current (AC).
Supply frequency Supply frequency (Hz).
Power input Maximum power consumption (VA).
Fuse rating Fuse rating: number of fuses, speed (T, slow acting), trip
current (A), breaking capacity (H high), maximum voltage
(V)
2 Safety instructions
2.2 Symbols and abbreviations
Sefia S-2000 Operating Instructions 29315810 AE 13

Symbol / text Description
Name and address of the manufacturer.
Other symbols on the instrument
Symbol Meaning
Warning! General warning symbol. Located on the peristaltic
pump.
Pinch hazard. Located on the peristaltic pump.
Power on.
Power off.
Symbols on the kit
The following symbols may be present on the kit:
Label Meaning
8
Number of units included in each box of single-use consumables.
Product number.
2 Safety instructions
2.2 Symbols and abbreviations
14 Sefia S-2000 Operating Instructions 29315810 AE

Label Meaning
Batch number in alphanumeric format.
Serial number.
Kit ID in barcode format that forms a unique traceability number.
STERILE EO
Sterilized using Ethylene oxide.
Non-pyrogenic.
Do not re-use.
Minimum and maximum ambient temperature during operation.
Use-by-date (YYYY-MM-DD).
Do not use in case the package is damaged.
Follow the Instructions for Use.
2 Safety instructions
2.2 Symbols and abbreviations
Sefia S-2000 Operating Instructions 29315810 AE 15

Label Meaning
Name and address of the manufacturer.
2 Safety instructions
2.2 Symbols and abbreviations
16 Sefia S-2000 Operating Instructions 29315810 AE

2.3 Emergency procedures
Introduction
This section describes how to shut down the Sefia instrument in an emergency situa-
tion, and the procedure for restarting the Sefia instrument. The section also describes
the result in the event of power failure.
Emergency shutdown
In an emergency situation, when the user interface of the Sefia instrument is not
responding, follow the steps below to stop the procedure:
Step Action
1On the control panel: Press the STOP button, until the process is aborted.
2Close all clamps on the processing kit to prevent any leakage if the stop-
cocks are not automatically closed.
Note:
Stopcocks are closed when the blue arms of the stopcock are not aligned
with any tubing line, as shown in the following illustration:
2 Safety instructions
2.3 Emergency procedures
Sefia S-2000 Operating Instructions 29315810 AE 17

Step Action
3Press the ON/OFF switch at the back of the instrument to the OFF position
(O).
4Disconnect the power cable from the instrument.
Controlled shutdown
If the Sefia instrument and software is functioning, follow the steps below to stop the
procedure:
Step Action
1On the control panel: Press the STOP button (or tap STOP on the touch
screen) to abort the procedure.
Result:
All stopcocks are closed, and a confirmation dialog is shown.
2Close all clamps on the processing kit.
3Tap OK to confirm aborting the procedure.
2 Safety instructions
2.3 Emergency procedures
18 Sefia S-2000 Operating Instructions 29315810 AE

Step Action
Result:
The process is aborted immediately.
4Tap (shutdown) at the top right of the screen.
Result:
A confirmation dialog is shown.
5Select Continue to confirm. Shutdown takes about one minute.
6Once shutdown is completed, press the ON/OFF switch at the back of the
instrument to the OFF position (O).
Power failure
In the event of a power failure to the Sefia instrument, the procedure is interrupted
immediately.
To prevent any leakage, close all clamps on the processing kit.
The procedural data collected up to the time of the power failure is available in the log
file.
Note: Connecting the Sefia instrument to an uninterruptible power supply (UPS)
can help to prevent loss of data and material during a power failure.
Restart after emergency shutdown or
power failure
When power is restored after a power failure or emergency shutdown, perform the
actions below as required:
Step Action
1Verify that all clamps on the processing kit are closed.
2Restart the Sefia instrument and the application software.
3Recover cells from the process, using SmartResume if applicable, the
Purge application, or manual purge with the pneumatic kit.
Refer to the Operator Manual for the application for specific guidance about recovering
cells.
2 Safety instructions
2.3 Emergency procedures
Sefia S-2000 Operating Instructions 29315810 AE 19

3 System description
About this chapter
This chapter gives an overview of the Sefia cell processing system, the control soft-
ware, and accessories .
In this chapter
Section See page
3.1 Description of the Sefia S-2000 instrument 21
3.2 Touch screen user interface 27
3.3 Using the Sefia instrument in regulated environments 29
3.4 System log 31
3.5 Data privacy and security 33
3.6 Applications and processing kits 35
3.7 Accessories 37
3 System description
20 Sefia S-2000 Operating Instructions 29315810 AE