cytiva VIA Thaw L1000 User manual

VIA Thaw L1000
Operating Instructions
Original instructions
VIA Thaw L1000
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 4
1.1 About this manual ......................................................................................................................................... 5
1.2 Important user information ....................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 8
2 Safety instructions ............................................................................................. 9
2.1 Safety precautions ........................................................................................................................................ 10
2.2 Symbols and abbreviations ........................................................................................................................ 11
2.3 Emergency procedures ............................................................................................................................... 12
3 System description ............................................................................................ 14
3.1 System overview ............................................................................................................................................ 15
3.2 User interface .................................................................................................................................................. 17
3.2.1 Control panel .................................................................................................................................................. 18
3.2.2 Start-up menu structure ........................................................................................................................... 21
3.2.3 Admin menu ................................................................................................................................................... 23
3.3 Thawing profiles ............................................................................................................................................. 27
4 Installation .......................................................................................................... 28
4.1 Site requirements .......................................................................................................................................... 29
4.2 Unpack the product ...................................................................................................................................... 30
4.3 Install VIA Thaw L1000 ................................................................................................................................ 31
4.4 Set up the system .......................................................................................................................................... 36
4.4.1 Start the instrument .................................................................................................................................... 37
4.4.2 Set date and time ......................................................................................................................................... 38
4.4.3 Factory reset ................................................................................................................................................... 41
4.5 Chronicle ........................................................................................................................................................... 42
4.6 Connect to the system network ............................................................................................................... 44
5 Preparation ......................................................................................................... 49
5.1 Prepare the instrument for a thawing .................................................................................................... 50
5.2 Cryobags ........................................................................................................................................................... 51
5.3 Manage thawing profiles ............................................................................................................................ 53
5.3.1 Manage thawing profiles on Chronicle ............................................................................................... 54
5.3.2 Manage thawing profiles on VIA Thaw L1000 .................................................................................. 55
6 Operation ............................................................................................................ 60
6.1 Overview ............................................................................................................................................................ 61
6.2 Select a thawing profile ............................................................................................................................... 63
6.3 Load a cryobag ................................................................................................................................................ 64
6.4 Thawing process ............................................................................................................................................ 68
6.5 End of a thawing process ............................................................................................................................ 69
6.6 Viewing thaw logs .......................................................................................................................................... 71
7 Maintenance ....................................................................................................... 73
7.1 Maintenance program ................................................................................................................................. 74
7.2 Cleaning before planned service ............................................................................................................. 75
Table of Contents
2 VIA Thaw L1000 Operating Instructions 29492479 AE

7.3 Cleaning and disinfection ........................................................................................................................... 76
7.4 Replacement procedures ........................................................................................................................... 80
7.5 Software maintenance ................................................................................................................................ 82
8 Troubleshooting ................................................................................................. 83
8.1 Alarms ................................................................................................................................................................ 84
8.2 Error codes ....................................................................................................................................................... 87
8.3 Instrument performance ............................................................................................................................ 88
8.4 Thawing performance .................................................................................................................................. 89
9 Reference information ....................................................................................... 90
9.1 Specifications .................................................................................................................................................. 91
9.2 Recycling information .................................................................................................................................. 93
9.3 Regulatory information ............................................................................................................................... 94
9.3.1 Contact information .................................................................................................................................... 95
9.3.2 European Union and European Economic Area .............................................................................. 96
9.3.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 97
9.3.4 Great Britain ................................................................................................................................................... 99
9.3.5 Regulatory statements .............................................................................................................................. 100
9.3.6 Regulations for North America ............................................................................................................... 101
9.3.7 Declaration of Hazardous Substances (DoHS) ................................................................................ 102
9.3.8 Wireless LAN .................................................................................................................................................. 104
9.4 Health and Safety Declaration Form ...................................................................................................... 105
Table of Contents
VIA Thaw L1000 Operating Instructions 29492479 AE 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, regu-
latory information, intended use of the product, and lists of associated documentation.
In this chapter
Section See page
1.1 About this manual 5
1.2 Important user information 6
1.3 Associated documentation 8
1 Introduction
4 VIA Thaw L1000 Operating Instructions 29492479 AE

1.1 About this manual
Purpose of this manual
This Operating Instructions describes the installation and operation of VIA Thaw™
L1000, as well as cleaning and routine maintenance procedures. For details on how to
set up remote management of the thawing profiles and data logs using Chronicle™,
visit https://pre-gmp.chronicle.bio.
Scope of this manual
This manual is intended as a guide for the installation, operation, care and mainte-
nance of VIA Thaw L1000.
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.
1 Introduction
1.1 About this manual
VIA Thaw L1000 Operating Instructions 29492479 AE 5

1.2 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 equipment.
Intended use of the product
VIA Thaw L1000 is intended for the thawing of a single frozen cryobag containing
10 to 275 mL of cryopreserved material.
VIA Thaw L1000 is intended for research or manufacturing use only. It is not intended
for clinical procedures or for diagnostic purposes.
VIA Thaw L1000 should only be used by a specifically trained scientist or technician in a
Process Development Laboratory or manufacturing environment.
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.
1 Introduction
1.2 Important user information
6 VIA Thaw L1000 Operating Instructions 29492479 AE

NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
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 Important user information
VIA Thaw L1000 Operating Instructions 29492479 AE 7

1.3 Associated documentation
Introduction
This section describes the user documentation that is delivered with the product, and
how to find related literature that can be downloaded or ordered from Cytiva.
User documentation for VIA Thaw
L1000
The user documentation listed in the table below is available in printed or PDF format.
Translations of the Operating Instructions are provided in electronic form on a CD.
Contact your Cytiva representative to obtain a copy of the documents.
Documentation Main contents
VIA Thaw L1000 Operating Instructions
(29492479)
(this document)
Instructions needed to prepare and
operate the VIA Thaw L1000 system 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.
VIA Thaw L1000 Cue Card (29492483) A short set of instructions on how to
perform a thawing process.
VIA Thaw L1000 Privacy and Security
Manual (29492819)
Description of the privacy and security
capabilities of VIA Thaw L1000.
1 Introduction
1.3 Associated documentation
8 VIA Thaw L1000 Operating Instructions 29492479 AE

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to the
instrument. In addition, the chapter describes emergency procedures.
In this chapter
Section See page
2.1 Safety precautions 10
2.2 Symbols and abbreviations 11
2.3 Emergency procedures 12
2 Safety instructions
VIA Thaw L1000 Operating Instructions 29492479 AE 9

2.1 Safety precautions
Introduction
Before installing, operating or maintaining the system, you must be aware of the
hazards described in this manual.
Follow the instructions in this section to avoid injury to the operator or other personnel,
damage to cryobag contents, to the product, or to other equipment in the area.
General precautions
The following general precautions must be considered at all times. There are also
context related precautions, which are written in their respective chapters.
WARNING
Hazardous substances and biological agents. When using
hazardous chemicals and biological agents, take all suitable
protective measures, such as wearing protective clothing, glasses
and gloves resistant to the substances used. Follow local and/or
national regulations for safe operation and maintenance of this
product.
CAUTION
Do not place objects on top of the instrument:
•Objects can fall when opening/closing the lid of the instrument
•Objects can become warm due to warming up of the heater
plates during normal operation of the instrument
NOTICE
VIA Thaw L1000 must remain upright during transport/
handling, operation, and storage. Transporting/handing, oper-
ating, or storing the unit in another orientation can cause damage
to the instrument.
2 Safety instructions
2.1 Safety precautions
10 VIA Thaw L1000 Operating Instructions 29492479 AE

2.2 Symbols and abbreviations
Introduction
This section describes the information on the system label and other safety or regula-
tory labels that are attached to the product.
Description of symbols on the system
label
The following symbols can be present on the instrument.
Label Meaning
This symbol indicates the serial number of the instrument.
This symbol indicates Warning!, read the user documentation
before using the system. Do not open any covers or replace parts
unless specifically stated in the user documentation.
This symbol indicates the location of a wired networking
terminal.
This symbol indicates the location of a fuse and the fuse rating.
Year (YYYY) and month (MM) of manufacture in YYYY-MM format.
Name and address of the manufacturer.
2 Safety instructions
2.2 Symbols and abbreviations
VIA Thaw L1000 Operating Instructions 29492479 AE 11

2.3 Emergency procedures
Introduction
This section describes how to shut down the VIA Thaw L1000 instrument in an emer-
gency situation, and the procedure for restarting the VIA Thaw L1000 instrument.
The section also describes the result in the event of power failure.
Emergency shutdown
WARNING
In an emergency situation, follow the emergency shutdown
procedure. Do not continue to use the system.
In an emergency situation, follow the steps below to stop the thawing process:
Step Action
1Press the power switch to the O position to completely turn off power to the
instrument.
2Unplug the instrument from the mains socket outlet.
Power failure
Power is required for the instrument to function.
The instrument does not contain an internal battery and in the absence of power it is
not operable.
NOTICE
In case of a power failure:
•The thawing process is interrupted immediately
•The thawing process data is not recorded in the thaw logs nor on
Chronicle
•The thawing process cannot be resumed
In case the mains power is restored following a power failure during a thawing process,
the instrument will generate a mains power failure alarm. See Section 8.1 Alarms, on
page 84.
2 Safety instructions
2.3 Emergency procedures
12 VIA Thaw L1000 Operating Instructions 29492479 AE

Restart after emergency shutdown or
power failure
Follow the steps below to restart the instrument after emergency shutdown or power
failure:
Step Action
1Make sure that the condition that caused the emergency shutdown is
corrected.
2Connect the power supply cord to the power outlet.
3Switch on the instrument.
2 Safety instructions
2.3 Emergency procedures
VIA Thaw L1000 Operating Instructions 29492479 AE 13

3 System description
About this chapter
This chapter gives an overview to VIA Thaw L1000, and a brief description of its func-
tion.
In this chapter
Section See page
3.1 System overview 15
3.2 User interface 17
3.3 Thawing profiles 27
3 System description
14 VIA Thaw L1000 Operating Instructions 29492479 AE

3.1 System overview
Introduction to VIA Thaw L1000
VIA Thaw L1000 tightly controls the heating of cryopreserved samples stored in cryo-
bags until it detects that the samples are thawed. Multiple sensors constantly monitor
the condition of the sample to determine when thawing is complete.
The system operates using dry heat to minimize the risk of sample contamination.
During the thawing process, VIA Thaw L1000 records data relating to the cryobag,
monitors the thawing process, and alerts the user to the following events:
•Loading temperature limit is exceeded
•Total thaw time limit is exceeded
•End-of-thaw temperature is exceeded
•Safe heater plate temperature is exceeded
•Loss of mains power
The cryobag data records are not indicated for the support of decisions related to the
suitability of a thawed cryobag for research or manufacturing.
A complete record of the thawing process can also be uploaded and viewed on
Chronicle web platform.
See Chapter 9 Reference information, on page 90 for more information about the
product.
Illustration of the instrument
The illustration below shows an overview of VIA Thaw L1000.
12 3 4 65
7
8
9
10
3 System description
3.1 System overview
VIA Thaw L1000 Operating Instructions 29492479 AE 15

Part Description
1 Thawing tray
2 Top heating plate
3 Barcode reader
4 Infrared (IR) sensors (x5)
5 Cryobag agitator (x4)
6 Grip
7 Lid
8 Bottom heating plate
9 Control panel
10 Drain plunger
Power and network connections
The illustration below shows the power and the network connections present on VIA
Thaw L1000.
2
3
1
4
Part Description
1 Appliance inlet
2 Fuse holder
3 Power switch
4 Network port
3 System description
3.1 System overview
16 VIA Thaw L1000 Operating Instructions 29492479 AE

3.2 User interface
In this section
Section See page
3.2.1 Control panel 18
3.2.2 Start-up menu structure 21
3.2.3 Admin menu 23
3 System description
3.2 User interface
VIA Thaw L1000 Operating Instructions 29492479 AE 17

3.2.1 Control panel
The illustration below shows the control panel of VIA Thaw L1000.
1
2 3
4
6 5
Part Description
1 Scroll up button
2 Display
3 Status indicator light
4 Scroll down button
5 Enter button
6 Acknowledge alarm button
User action symbols
The following table shows symbols that are used to highlight user actions in this
manual.
Note: To access a previous menu level, press and hold .
3 System description
3.2 User interface
3.2.1 Control panel
18 VIA Thaw L1000 Operating Instructions 29492479 AE

User action Function
Tap
Wait
Up
Down
Enter
Acknowledge alarm
Thawing profile screen
The instrument is ready to start a thawing process when the Thawing profile screen is
displayed.
The illustration below shows the thawing profile information that appears on the
Thawing profile screen.
2
4
6 5
1
3
Part Description
1 Profile name
2 Current date and time
3 System description
3.2 User interface
3.2.1 Control panel
VIA Thaw L1000 Operating Instructions 29492479 AE 19

Part Description
3 Connectivity status:
Wired network link active
Wireless network link active
Connected to Chronicle
Wired network link not active
Wireless network link not active
4Time alarm value for the selected profile
5 Load temperature value for the selected profile
6 Fill volume for the selected profile
3 System description
3.2 User interface
3.2.1 Control panel
20 VIA Thaw L1000 Operating Instructions 29492479 AE