Terumo BCT Quantum Cell Expansion System User manual

Quantum®
Cell Expansion System
SOFTWARE VERSION 2.1
Operator’s Manual

Quantum®Cell Expansion System
Operator's Manual for Software Version 2.1
Part No. 104101-164
Reorder No. 720394-002
2016-01

©2011, 2016 Terumo BCT, Inc.
Terumo BCT is either a registered trademark or a trademark of
Terumo Corporation.
Quantum is a registered trademark of Terumo BCT, Inc.
The Quantum Cell Expansion System is covered by one or more
of the following patents:
United States: 7718430; 8163555; 8309347; 8321145;
8399245
China: ZL200780001348.0; ZL200880006794.5
Japan: 5149313
Terumo BCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215
USA
USA Phone: [phone]
Phone: [phone]
USA Fax: [phone]
Fax: [phone]
Terumo BCT Europe N.V.
Ikaroslaan 41
1930 Zaventem
Belgium
Phone: [phone]
Fax: [phone]
Terumo BCT (Asia Pacific) Ltd.
Room 3903-3903A, 39/F
ACE Tower, Windsor House
311 Gloucester Road
Causeway Bay, Hong Kong
Phone: [phone]
Fax: [phone]
Terumo BCT Latin America S.A.
La Pampa 1517–12th Floor
C1428DZE
Buenos Aires
Argentina
Phone: [phone]
Fax: [phone]
TERUMOBCT.COM

Contents
1: Preface
About this Manual ............................................................................................................................................. 1-2
Document Conventions ..................................................................................................................................... 1-2
Warning, Caution, and Note Definitions ........................................................................................................... 1-3
Intended Use ...................................................................................................................................................... 1-3
Warnings for Use ............................................................................................................................................... 1-4
System Warnings ....................................................................................................................................... 1-4
Service Warnings ....................................................................................................................................... 1-5
Electrical Warnings .................................................................................................................................... 1-5
Cell Expansion Process Warnings .............................................................................................................. 1-5
Cautions for Use ................................................................................................................................................ 1-6
System Cautions ........................................................................................................................................ 1-6
Service Cautions ........................................................................................................................................ 1-6
Cell Expansion Process Cautions ............................................................................................................... 1-6
Service Information ............................................................................................................................................ 1-8
Return of Used Product ...................................................................................................................................... 1-8
Use of Additional Devices and Supplies During Cell Expansion ......................................................................... 1-9
Disposal of Infectious and Non-Infectious Waste ............................................................................................... 1-9
2: Introduction
Quantum System Overview ................................................................................................................................ 2-2
Quantum System Components .......................................................................................................................... 2-3
Pumps ....................................................................................................................................................... 2-7
Valves ........................................................................................................................................................ 2-9
Sensors and Fluid Detectors ..................................................................................................................... 2-11
Hydraulic Layout ............................................................................................................................................. 2-12
Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1 i

Quantum System Cell Expansion Sets .............................................................................................................. 2-13
Accessory Sets .......................................................................................................................................... 2-14
About User Authentication ............................................................................................................................... 2-15
User Role ................................................................................................................................................. 2-15
Signing In to the System .......................................................................................................................... 2-16
Signing Out of the System ....................................................................................................................... 2-16
Changing Your Password ......................................................................................................................... 2-16
Turning On the Quantum System ................................................................................................................... 2-18
Turning Off the Quantum System ................................................................................................................... 2-18
3: Touch Screen
About the Touch Screen ..................................................................................................................................... 3-2
Home Screen ...................................................................................................................................................... 3-2
Status Bar .................................................................................................................................................. 3-5
General Navigation Buttons ............................................................................................................................... 3-7
Touch Screen Views ........................................................................................................................................... 3-9
Utilities Screen ................................................................................................................................................. 3-12
Task Selection Screen ....................................................................................................................................... 3-13
Setup Confirmation Screen .............................................................................................................................. 3-15
Setup Screen ..................................................................................................................................................... 3-17
Help Window .................................................................................................................................................. 3-20
Using the Data Entry Pad ................................................................................................................................. 3-21
4: Troubleshooting
Troubleshooting Alarms ..................................................................................................................................... 4-2
Clearing An Alarm ..................................................................................................................................... 4-5
About Remote Alarm Notification ..................................................................................................................... 4-5
Power Fail Recovery ........................................................................................................................................... 4-6
5: Operator Procedures
Preparing the System .......................................................................................................................................... 5-2
Filling the Media Bags ............................................................................................................................... 5-2
Filling the Cell Inlet Bags .......................................................................................................................... 5-3
Replacing a Bag .................................................................................................................................................. 5-3
Using the In‑line Filter 200 Micron Accessory Set .............................................................................................. 5-4
Taking a Sample from the Sample Coil .............................................................................................................. 5-5
Taking a Sample from the Sample Port .............................................................................................................. 5-7
6: Performing Tasks
About Tasks ....................................................................................................................................................... 6-2
About Settings .................................................................................................................................................... 6-4
Selecting the IC Inlet or EC Inlet ....................................................................................................................... 6-6
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Entering Pump Rates .......................................................................................................................................... 6-7
Automatically Calculated Pump Rates ....................................................................................................... 6-7
Outlet ................................................................................................................................................................. 6-9
Selecting an Outlet .................................................................................................................................... 6-9
Rocker .............................................................................................................................................................. 6-11
In Motion ................................................................................................................................................ 6-11
Stationary ................................................................................................................................................ 6-13
Selecting Stationary as the Rocker Setting ................................................................................................ 6-13
Stop Condition ................................................................................................................................................ 6-14
Manual .................................................................................................................................................... 6-14
Time ........................................................................................................................................................ 6-15
Exchange ................................................................................................................................................. 6-16
IC Volume ............................................................................................................................................... 6-17
EC Volume .............................................................................................................................................. 6-18
Empty Bag ............................................................................................................................................... 6-18
Inlet Volume ........................................................................................................................................... 6-18
System ..................................................................................................................................................... 6-19
Table of Tasks .................................................................................................................................................. 6-20
7: Set Management Tasks
Load Cell Expansion Set ..................................................................................................................................... 7-2
Prime Cell Expansion Set ................................................................................................................................. 7-10
Separating the Tubing Lines .................................................................................................................... 7-11
Unload Cell Expansion Set ............................................................................................................................... 7-12
Connect Sampling Coil .................................................................................................................................... 7-13
8: System Management Tasks
Remove IC Air ................................................................................................................................................... 8-2
Remove EC Air .................................................................................................................................................. 8-4
Condition Media ................................................................................................................................................ 8-6
Coat Bioreactor .................................................................................................................................................. 8-8
9: Washout Tasks
High Density Washout ....................................................................................................................................... 9-2
Rapid IC Washout ............................................................................................................................................. 9-3
IC EC Washout ................................................................................................................................................. 9-5
IC EC Washout Through Membrane ................................................................................................................. 9-7
Inlet Line Washout ............................................................................................................................................. 9-9
10: Load and Attach Tasks
Load Cells With Circulation ............................................................................................................................ 10-2
Load Cells Without Circulation ....................................................................................................................... 10-5
Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1 iii

Attach Cells ...................................................................................................................................................... 10-7
Load Cells With Uniform Suspension .............................................................................................................. 10-9
11: Feed and Add Tasks
Feed Cells With Ultrafiltration ......................................................................................................................... 11-2
Feed Cells ......................................................................................................................................................... 11-4
Add Bolus ......................................................................................................................................................... 11-6
Add Bag Contents ............................................................................................................................................ 11-8
Add Fluid Continuously ................................................................................................................................. 11-10
Add Fluid Continuously With Ultrafiltration ................................................................................................. 11-12
12: Release and Harvest Tasks
Release Adherent Cells ...................................................................................................................................... 12-2
Release Adherent Cells And Harvest ................................................................................................................. 12-5
Harvest Cells .................................................................................................................................................... 12-9
13: Custom Tasks
Custom Tasks ................................................................................................................................................... 13-2
14: Quantum System Configuration
Quantum System Configuration ...................................................................................................................... 14-2
15: Reports
About Reports .................................................................................................................................................. 15-2
Run Reports ............................................................................................................................................ 15-2
User Reports ............................................................................................................................................ 15-3
Configuration Reports ............................................................................................................................. 15-4
Viewing Reports ............................................................................................................................................... 15-5
Viewing a Current Report ........................................................................................................................ 15-5
Viewing a Stored Run Report .................................................................................................................. 15-5
Sorting Stored Run Reports ..................................................................................................................... 15-6
Deleting Stored Run Reports ............................................................................................................................ 15-7
Sending Reports ............................................................................................................................................... 15-8
Sending a Current Report ........................................................................................................................ 15-8
Sending Stored Run Reports .................................................................................................................... 15-8
Editing the Name of the Current Run Report .................................................................................................. 15-9
Editing the Name of the Current Run Report at the Start of Load Cell Expansion Set ............................ 15-9
Editing the Name of the Current Run Report from the Reports Screen ................................................... 15-9
Recording Temperature and Pressure on a Run Report .................................................................................. 15-10
16: Maintaining the Quantum System
Installing the Quantum System ........................................................................................................................ 16-2
Electrical Requirements .................................................................................................................................... 16-2
iv Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1

Maintaining the Quantum System ................................................................................................................... 16-2
Cleaning the System ......................................................................................................................................... 16-2
Disinfecting the System .................................................................................................................................... 16-3
Performing Preventive Maintenance ................................................................................................................. 16-3
17: System Specifications
System Specifications ........................................................................................................................................ 17-2
Environmental Specifications ................................................................................................................... 17-2
Electrical Power and Safety Specifications ................................................................................................ 17-2
Physical Specifications ............................................................................................................................. 17-3
Touch Screen Specifications ..................................................................................................................... 17-4
Electromagnetic Compatibility (EMC) Information ................................................................................ 17-5
Symbols .......................................................................................................................................................... 17-10
Glossary
Index
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vi Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1

1
Preface
Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1 1-1

About this Manual
This manual is written for personnel who are responsible for operating the Quantum®Cell Expansion
System. It includes information and instructions on how to operate, troubleshoot, and maintain the
system. You should read and understand the information in this manual before operating the system.
Document Conventions
This document uses certain conventions to help you identify information. This section describes these
conventions.
Numbered Steps
All sequential, multiple-step instructions are numbered, as shown in the following example:
1. Attach the media bag to the cell line.
2. Hang the bag on the bag pole.
Bold Text
Certain steps instruct you to touch a button on the screen. Buttons appear in bold, as shown in the
following example:
1. Touch Task.
Bullets
Bullets (•) indicate list items that are not sequential.
Preface
1-2 Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1

Warning, Caution, and Note Definitions
The following examples show how warnings, cautions, and notes appear in this document:
Warning: Warnings alert the operator of serious hazards, consequences, or conditions that are likely
to result in a harmful reaction, trauma, or death to the operator.
Caution: Cautions alert the operator to the possibility of a problem with the system associated with its use or
misuse. This includes system malfunction, failure, and damage to the system or other property.
Note: Notes emphasize important details.
Intended Use
Warning: It is the responsibility of the user to validate the safety and efficacy of the expanded cells for
their intended application. Expanded cell products for use in human subjects or patients must comply
with all applicable country-specific regulatory requirements.
The Quantum Cell Expansion System, afunctionally closed cell expansion system, may be used to grow
adherent and suspension cells in laboratory, clinical, and manufacturing environments.
Warning, Caution, and Note Definitions
Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1 1-3

Warnings for Use
The following section includes a complete list of the warnings that apply to the use of the Quantum
system. Although the information may also appear in the other sections of this manual, operators should
read and understand the information in this list before using the system. For specific warnings about a
tubing set, refer to the instructions for use that ship with the tubing set.
System Warnings
1. Do not use the Quantum system under any of the following conditions:
• Any power cords, plugs, or receptacles are damaged or worn.
• Any switches on the device are loose.
• The device has received a physical shock, or liquid has spilled on the electronics.
• Anyone has received an electrical shock while using the system.
• The device appears to be overheating.
2. Only trained and qualified personnel should move the Quantum device.
3. To avoid the risk of an explosion, the oxygen concentration in the gas supplied to the system must
not exceed 20%.
4. The Quantum system includes an external pressure relief valve rated to 75 psi that is located on the
back of the device. Do not block the valve discharge area. When gas pressures exceed 75 psi, the
relief valve opens and releases high pressure gas. Protect the area from possible contact with
personnel.
5. Do not block the external gas connection located on the back of the device on the bottom‑left
corner. This connection also functions as a safety disconnect for the device.
6. Individuals who operate the Quantum system must be appropriately qualified and trained.
7. Avoid pinching your fingers when opening and closing the incubator door.
8. Always place the device on asturdy, even surface so that the device is completely supported, which
reduces the risk of the device falling or slipping off the supporting surface.
9. Use caution when interacting with the Quantum device, because it has moving parts that could
injure fingers and entangle hair, clothing, or other personal articles.
10. Do not lean on or place heavy objects on the incubator door when it is open. Doing so could cause
the device to tip and fall.
11. It is the responsibility of the user to validate the safety and efficacy of the expanded cells for their
intended application. Expanded cell products for use in human subjects or patients must comply
with all applicable country-specific regulatory requirements.
12. If the Quantum system is used in a manner not specified by the manufacturer, the operator
protection systems may not be effective in preventing injury to the operator.
13. It is the responsibility of the user to determine any effect residual EtO may have on cells that are
cultured in the Quantum system.
14. Use only power cords specified by Terumo BCT. The use of inadequately rated cords could
possibly cause property damage or bodily harm.
Preface
1-4 Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1

Service Warnings
1. Only aqualified service representative should service or modify the device. Any modifications must
be approved in writing by Terumo BCT.
2. Turn off the primary power switch and unplug the device before cleaning.
3. Use acleaning technique that does not place your finger in avulnerable position. For example, you
can clean the area around the valve with a cotton swab or by using a flossing technique.
4. Take adequate precautions when cleaning any surfaces of the device that might have been exposed
to blood to prevent possible exposure to and transmission of infectious diseases.
Electrical Warnings
1. All electrical installations must comply with all applicable local electrical codes and the Quantum
system electrical specifications.
2. To avoid a serious shock, do not install the system on a workstation where fluid may accumulate.
3. Do not place open containers of fluid on the device. Fluid spills can contribute to electrical and
mechanical hazards.
4. If aspill occurs on the primary power switch or on the auxiliary power switch, unplug the device and
call your service representative. Do not touch the switch to turn off the power.
5. To reduce the risk of electrical shock, do not use an adapter that breaks the protective ground.
Cell Expansion Process Warnings
1. Follow your institution’s standard operating procedures for wearing personal protective equipment
when using the Quantum system.
2. Always use protective eyewear when operating the Quantum system.
3. Do not clamp the lines to control the flow of fluid through the cell expansion set. Clamping the
lines can cause excessive pressure, resulting in possible injury to the operator and damage to the cell
expansion set. Allow the system to control the flow of fluid.
4. All used cell expansion set materials should be considered biohazardous and should be handled and
disposed of in accordance with applicable regulations.
5. Do not use excessive force when loading or unloading the cell expansion set, because this could lead
to operator injury.
Warnings for Use
Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1 1-5

Cautions for Use
The following section includes a complete list of the cautions that apply to the use of the Quantum
system. Although the information may also appear in the other sections of this manual, operators should
read and understand the information in this list before using the system. For specific cautions about a
tubing set, refer to the instructions for use that ship with the tubing set.
System Cautions
1. Each operator should be thoroughly familiar with the operating instructions for the Quantum
system before using the device.
2. Do not adjust the gas flow control knob, or you may disrupt the pressure in the system. Only a
qualified service representative should adjust the gas flow.
3. The system does not produce an alarm when the gas supply is depleted; therefore, you must monitor
the gas supply throughout operation of the system.
4. Keep the network ports located on the front of the device covered to prevent fluid from entering.
5. The Quantum system is meant for indoor use only.
6. Do not use a stylus with the Quantum system touch screen.
7. The temperature of the operating environment for the Quantum system should be maintained
between 16 °C and 27 °C (60.8 °F and 80.6 °F).
8. The rotor cover on each pump must be closed and the rotor latch must be locked before you turn on
and operate the system.
9. At least two people are needed to lift the Quantum system. Use proper lifting techniques when
lifting the Quantum system.
10. Use only the cell expansion sets and the accessory sets that Terumo BCT manufactures for the
Quantum system.
11. Use only the accessory bags that Terumo BCT manufactures for the Quantum system. Using bags
of inappropriate size may cause excess pressure to accumulate in the system.
Service Cautions
1. To disinfect the device, use only a0.25% sodium hypochlorite (bleach) solution. Using astronger
bleach solution may damage or discolor the device.
2. Do not lubricate the pumps or the pump rotors for any reason.
3. Do not block access to the primary power switch, which is located on the back of the device, during
installation.
Cell Expansion Process Cautions
1. Use aseptic technique during cell expansion processes to ensure product quality.
2. When priming the cell expansion set, do not connect the fluids to the cell expansion set before you
are instructed to do so.
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1-6 Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1

3. It is very important that the operator address any leaks that arise when acell expansion set is in use
because a set may occasionally fail. If a cell expansion set fails, it could result in the loss of cell
products or the introduction of air into the set.
4. Periodically inspect the EC (extracapillary) inlet port and the EC outlet port for air, and if either
port contains visible air, remove the air by performing the Remove EC Air task.
5. Periodically inspect the IC (intracapillary) inlet header and the IC outlet header for air, and if either
header contains visible air, remove the air by performing the Remove IC Air task.
6. Do not use chilled fluid to prime the cell expansion set.
7. Use only your fingers to load the cell expansion set. Do not use asharp object, or you may puncture
the tubing.
8. When loading the cell expansion set, do not turn the internal mounting clips more than a quarter
turn, or you could pinch the tubing.
9. If you have loaded acell expansion set but you do not plan to prime the set until the following day,
turn off the external gas supply to avoid excess gas buildup in the waste bag.
10. When you seal each line loop, seal it in alocation that ensures that each resulting line has aname tag.
For example, the EC media tag should be located on one line and the reagent tag on the other line;
the IC media tag should be located on one line and the wash tag on the other line.
11. When you attach abag to the cell expansion set, ensure that the bag is attached to the proper line and
that the sterile weld is completely open before starting any tasks.
12. When using the In‑line Filter 200 Micron Accessory Set, sterile weld to the blue luer end first or you
may lose the cell product.
Cautions for Use
Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1 1-7

Service Information
Warning: Only a qualified service representative should service or modify the device. Any
modifications must be approved in writing by Terumo BCT.
Return of Used Product
If for any reason this product must be returned to Terumo BCT, Inc., a returned goods authorization
(an RGA number) is required from Terumo BCT prior to shipping.
Instructions for cleaning and materials, including appropriate shipping containers, proper labeling, and
an RGA number, may be obtained from the Terumo BCT Quality Assurance Department.
IT IS THE RESPONSIBILITY OF THE INSTITUTION TO ADEQUATELY PREPARE AND
IDENTIFY THE PRODUCT FOR RETURN SHIPMENT.
Please contact your local representative for information regarding returned goods and product
complaints.
Preface
1-8 Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1

Use of Additional Devices and Supplies During Cell Expansion
You need some or all of the following devices and supplies when using the Quantum system:
•A tubing pump
• A tubing sealer
• A sterile tubing welder with the appropriate replacement wafers
• A glucose and lactate analyzer (optional)
• Mixed gas tanks with pressure regulators
• A hose with the connector specified in Table 17-3 of this manual to connect to the external gas
supply
• Cell culture fluids
For instructions on how to safely use these items with the Quantum system, refer to the guidelines
provided by each of the device or supply manufacturers.
Disposal of Infectious and Non-Infectious Waste
Follow your local regulations for disposing of material that may be contaminated with biohazardous
products.
Use of Additional Devices and Supplies During Cell Expansion
Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1 1-9

Preface
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2
Introduction
Quantum®Cell Expansion System • Operator's Manual for Software Version 2.1 2-1