Roche FLOW PCR Setup User manual

Roche
Brand
Roche
Model
FLOW PCR Setup
Type
User manual
FLOW Primary Sample Handling and
PCR Setup Operator's Guide
Version 6.0, Software Version 3.0 August 2021
For general laboratory use.
Table of contents
3
Prologue 7
I Document information ................................................................................................................................ 7
1 Revision history ................................................................................................................................................... 7
2 Edition notice ....................................................................................................................................................... 9
3 Copyright ............................................................................................................................................................... 9
4 Trademarks ........................................................................................................................................................... 9
II Contact addresses ...................................................................................................................................... 10
III Approvals ......................................................................................................................................................... 10
IV Warranty ........................................................................................................................................................... 11
V Intended use .................................................................................................................................................. 11
VI Preamble .......................................................................................................................................................... 11
VII Contents of this Operator’s Guide ..................................................................................................... 11
VIII Conventions used in this guide ........................................................................................................... 12
IX Warnings and precautions ..................................................................................................................... 14
1 Handling precautions .................................................................................................................................... 14
2 General precautions ....................................................................................................................................... 15
3 About software and data security ............................................................................................................. 17
4 Electrical safety ................................................................................................................................................ 18
X Disposal of the instrument ..................................................................................................................... 18
A Overview 19
1 Introduction .................................................................................................................................................... 19
2 Specifications of the FLOW PCR Setup Instrument ................................................................. 21
2.1 General specifications ................................................................................................................................... 21
2.1.1 Shipping .............................................................................................................................................................. 21
2.1.2 Environmental requirements ....................................................................................................................... 21
2.2 Technical specifications ............................................................................................................................... 22
2.3 Specifications of the barcode readers .................................................................................................... 23
2.4 Barcode specifications .................................................................................................................................. 24
2.5 Specifications for LIS ..................................................................................................................................... 25
2.6 Uninterruptible power supply ..................................................................................................................... 25
B System description 27
1 The FLOW PCR Setup System .............................................................................................................. 27
1.1 The FLOW PCR Setup Instrument ............................................................................................................. 27
1.1.1 Front view ........................................................................................................................................................... 28
1.1.2 Back of the instrument ................................................................................................................................. 30
1.1.3 Sides of the instrument ................................................................................................................................. 31
1.2 Main components ........................................................................................................................................... 32
1.2.1 Modular robotic arm ...................................................................................................................................... 32
1.2.2 1000 µl pipetting channels .......................................................................................................................... 33
1.2.3 Autoload ............................................................................................................................................................. 34
1.2.4 CO-RE grip ......................................................................................................................................................... 36
1.2.5 Teaching needles ............................................................................................................................................ 37
1.2.6 Waste station .................................................................................................................................................... 38
1.2.7 Deck layout ........................................................................................................................................................ 38
1.3 Disposables ....................................................................................................................................................... 43
1.4 Accessories ....................................................................................................................................................... 46
FLOW Primary Sample Handling and PCR Setup, Operator’s Guide Version 6.0
Table of contents
4
1.5 Custom primary/secondary tubes ............................................................................................................. 49
1.5.1 Sample types ..................................................................................................................................................... 50
1.5.2 Sample volumes ............................................................................................................................................... 51
1.5.3 Reagent types ................................................................................................................................................... 52
1.5.4 Reagent volumes ............................................................................................................................................. 52
2 Installation ....................................................................................................................................................... 53
2.1 Installation requirements .............................................................................................................................. 53
2.2 Technology ......................................................................................................................................................... 53
C Software 57
1 General software conventions ............................................................................................................. 57
1.1 Buttons ................................................................................................................................................................ 57
1.2 Working with tables ........................................................................................................................................ 57
2 FLOW PCR Setup System in Primary Sample Handling mode ........................................... 59
2.1 Starting the software ...................................................................................................................................... 59
2.2 The main window ............................................................................................................................................ 60
2.2.1 Information bar ................................................................................................................................................. 60
2.2.2 Working window area .................................................................................................................................... 61
2.2.3 Global action bar ............................................................................................................................................. 62
2.2.4 Status bar ........................................................................................................................................................... 63
2.3 Closing the software ....................................................................................................................................... 63
3 Standalone configuration (PSH) ......................................................................................................... 64
3.1 Run with individual run parameters ......................................................................................................... 64
3.1.1 Run parameters ................................................................................................................................................ 64
3.1.2 Open/Close vertical cover message box ................................................................................................ 67
3.1.3 Please load deck as specified below dialog box ................................................................................. 68
3.1.4 Sample loading results .................................................................................................................................. 69
3.1.5 Edit Tip Count dialog box ............................................................................................................................. 71
3.1.6 2ml FLOW tube with STOP barcode ......................................................................................................... 72
3.1.7 Insufficient Liquid message box ................................................................................................................ 73
3.1.8 Internal Controls message box ................................................................................................................... 74
3.1.9 Processing view ................................................................................................................................................ 74
3.1.10 End of run ........................................................................................................................................................... 76
3.1.11 Data transfer to the MagNA Pure 96 Instrument ................................................................................ 77
3.2 Run with worklist ............................................................................................................................................. 78
3.2.1 Worklist file selection ..................................................................................................................................... 78
3.2.2 Run parameters ................................................................................................................................................ 79
3.2.3 Please load deck as specified below dialog box ................................................................................. 80
3.2.4 Open/Close vertical cover message box ................................................................................................ 80
3.2.5 Sample loading results .................................................................................................................................. 81
3.2.6 Edit Tip Count dialog box ............................................................................................................................. 82
3.2.7 2ml FLOW tube with STOP barcode ......................................................................................................... 82
3.2.8 Insufficient Liquid message box ................................................................................................................ 82
3.2.9 Internal Controls message box ................................................................................................................... 82
3.2.10 Processing view ................................................................................................................................................ 82
3.2.11 End of run ........................................................................................................................................................... 83
3.2.12 Data transfer to the MagNA Pure 96 System ....................................................................................... 83
4 FLOW configuration (PSH) ..................................................................................................................... 84
4.1 FLOW Worklist overview ............................................................................................................................... 84
4.2 Please load deck as specified below dialog box ................................................................................. 86
4.3 Open/Close vertical cover message box ................................................................................................ 86
4.4 Sample loading results .................................................................................................................................. 87
4.5 2ml FLOW tube with STOP barcode ......................................................................................................... 89
4.6 Additional dialog boxes ................................................................................................................................. 89
4.6.1 Edit Tip Count dialog box ............................................................................................................................. 89
4.6.2 IC tube is empty; refill IC to continue ...................................................................................................... 89
4.6.3 Please refill the labware positions with IC liquid of barcode message box .............................. 90
4.7 Processing view ................................................................................................................................................ 90
Table of contents
5
4.8 Process Samples Review .............................................................................................................................. 91
4.9 End of run .......................................................................................................................................................... 92
4.10 Data transfer ..................................................................................................................................................... 92
5 Aborting a run ................................................................................................................................................ 93
5.1 Operator-controlled abort ............................................................................................................................ 93
5.2 Instrument-controlled abort ........................................................................................................................ 93
5.3 Emergency shutdown .................................................................................................................................... 93
6 Administrative tasks (PSH) ................................................................................................................... 94
6.1 User management .......................................................................................................................................... 94
6.2 Worklists ............................................................................................................................................................. 94
6.2.1 FLOW configuration ....................................................................................................................................... 94
6.2.2 Standalone configuration ............................................................................................................................. 94
6.3 Application Configuration Editor (PSH) .................................................................................................. 96
6.4 Order templates for MagNA Pure 96 Software ................................................................................... 99
6.5 Network interaction ........................................................................................................................................ 99
7 FLOW PCR Setup System in PCR Setup mode ......................................................................... 100
7.1 Starting the software ................................................................................................................................... 100
7.2 The main window .......................................................................................................................................... 100
7.2.1 Information bar .............................................................................................................................................. 101
7.2.2 Working window area ................................................................................................................................. 101
7.2.3 Global action bar ........................................................................................................................................... 101
7.2.4 Status bar ......................................................................................................................................................... 102
7.3 Closing the software .................................................................................................................................... 102
8 PCR Setup FLOW configuration ........................................................................................................ 103
8.1 Settings ............................................................................................................................................................. 103
8.2 PCR Test Setup Overview ........................................................................................................................... 104
8.2.1 Reaction Mix Preparation - Overview tab ............................................................................................ 104
8.2.2 Transfer Reaction Mixes - Overview tab .............................................................................................. 105
8.3 PCR Test Setup Execute ............................................................................................................................. 106
8.3.1 Processing view ............................................................................................................................................. 106
8.3.2 Open/Close vertical cover message box .............................................................................................. 107
8.3.3 Load tips message box ............................................................................................................................... 108
8.3.4 Edit Tip Count dialog box ........................................................................................................................... 108
8.3.5 Load Reagents message box .................................................................................................................... 110
8.3.6 Missing Tubes message box ..................................................................................................................... 111
8.3.7 Load labware message box ....................................................................................................................... 111
8.3.8 Successfully processed message box ................................................................................................... 112
8.4 PCR Test Setup Review ............................................................................................................................... 112
8.4.1 Reaction Mix Preparation - Review tab ................................................................................................ 112
8.4.2 Transfer Reaction Mixes - Review tab .................................................................................................. 113
8.4.3 Unload of Carriers message box ............................................................................................................. 114
8.4.4 After clicking Continue button ................................................................................................................. 114
8.5 PCR Sample Transfer Overview ............................................................................................................... 115
8.5.1 Transfer Samples - Overview tab ............................................................................................................ 115
8.5.2 Transfer Controls - Overview tab ............................................................................................................ 116
8.6 PCR Sample Transfer Execute .................................................................................................................. 116
8.6.1 Open/close vertical cover message box ............................................................................................... 116
8.6.2 Load Controls message box ...................................................................................................................... 117
8.6.3 Load labware message box ....................................................................................................................... 117
8.6.4 Load tips message box ............................................................................................................................... 117
8.6.5 Edit Tip Count dialog box ........................................................................................................................... 117
8.6.6 Successfully processed message box ................................................................................................... 117
8.7 PCR Sample Transfer Review ................................................................................................................... 117
8.7.1 Transfer Samples - Review tab ................................................................................................................ 118
8.7.2 Transfer Controls - Review tab ................................................................................................................ 118
8.8 End of run ........................................................................................................................................................ 120
FLOW Primary Sample Handling and PCR Setup, Operator’s Guide Version 6.0
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9 Aborting a run ............................................................................................................................................. 121
9.1 Operator-controlled abort ......................................................................................................................... 121
9.2 Instrument-controlled abort ..................................................................................................................... 121
9.3 Emergency shutdown ................................................................................................................................. 121
10 Administrative tasks ............................................................................................................................... 122
10.1 User management ........................................................................................................................................ 122
10.2 Worklists .......................................................................................................................................................... 122
10.3 Network interaction ..................................................................................................................................... 122
D Maintenance and care 123
1 Operator maintenance ........................................................................................................................... 123
1.1 Starting and aborting a maintenance routine ................................................................................... 124
1.2 Daily maintenance ....................................................................................................................................... 126
1.3 Weekly maintenance ................................................................................................................................... 129
1.4 Report file ........................................................................................................................................................ 133
1.5 On-demand maintenance ......................................................................................................................... 134
2 Service maintenance .............................................................................................................................. 142
E Troubleshooting 143
1 Startup problems ...................................................................................................................................... 143
2 Problem report ........................................................................................................................................... 143
3 Remote service .......................................................................................................................................... 144
4 Run-time error handling ....................................................................................................................... 145
4.1 Vertical Cover - Error .................................................................................................................................. 145
4.2 Identify carrier - Error ................................................................................................................................. 146
4.3 Barcode error ................................................................................................................................................. 147
4.3.1 User Input dialog box (PCR Setup Software specific) .................................................................... 147
4.3.2 Insert Barcode dialog box (Primary Sample Handling Software specific) .............................. 148
4.4 Tip loading errors ......................................................................................................................................... 148
4.5 1000 µl Channel Tip Pick Up - Error ...................................................................................................... 149
4.6 Maintenance interval error ....................................................................................................................... 150
4.7 Internal control error ................................................................................................................................... 150
5 Errors for primary sample transfer .................................................................................................. 152
6 Error data transfer .................................................................................................................................... 153
7 Errors during PCR test setup and PCR sample transfer ..................................................... 154
8 Error handling concerning the UV decontamination ............................................................ 156
F Appendix 157
1 Glossary .......................................................................................................................................................... 157
2 Index ................................................................................................................................................................. 165
Prologue
Document information
7
Prologue
I Document information
1 Revision history
Operator’s
Guide
Version
Software Version Revision
Date
Changes
V1.0 FLOW PCR Setup Instrument Software V1.0 October 2013 First edition
V2.0 FLOW PCR Setup Instrument Software V1.2 July 2014 Update:
New software version 1.2
New tube type
introduced
Ready to Use Mix
enabled
Editorial corrections
V3.0 FLOW PCR Setup Instrument Software V2.0 January 2015 Update:
New software version 2.0
Improved error handling
Additional controls,
standards, and
calibrators specified
Improved processing
Deck layout update
Editorial corrections
V4.0 FLOW PCR Setup Instrument Software V2.1 November
2015
Update:
New intended use
New software version 2.1
Deck layout update
Optimized user interface
Editorial corrections
V5.0 FLOW PCR Setup Instrument Software V2.1 February
2018
Update:
Integration of FLOW
Primary Sample Handling
System content
Editorial corrections
FLOW Primary Sample Handling and PCR Setup, Operator’s Guide Version 6.0
Document information
8
V6.0 FLOW Primary Sample Handling Software
V3.0 and FLOW PCR Setup Software V3.0
August 2021 Information about
PSH Software now included
in this Operator's Guide.
Updated for changes in new
software version 3.0 includ-
ing, but not limited to:
Windows 10 OS
STOP barcode option
now available for the PSH
Software
Now possible to place up
to 5 MagNA Pure output
plates on PSU
Now possible to add
manually barcode entry
on PSU
Editorial corrections
Prologue
Document information
9
2 Edition notice
This Operator’s Guide is for users of the following configurations:
The FLOW solution configuration, where the FLOW PCR Setup System is used as a
primary sample handling and PCR setup instrument.
The standalone configuration, where the FLOW PCR Setup System is used as a
primary sample handling instrument in combination with the MagNA Pure 96 System.
The FLOW Primary Sample Handling Instrument, Cat. No. 07101937001, has been replaced by the
FLOW PCR Setup Instrument, Cat No. 07101996001, since 2018. The only difference between these
2 instruments is that the FLOW Primary Sample Handling Instrument has only 4 pipetting channels
while the FLOW PCR Setup Instrument has 8 pipetting channels. All other hardware feature are the
same.
Only 4 pipetting channels are used for the sample transfer regardless of which instrument is used for
the primary sample handling.
The FLOW Primary Sample Handling Software Version 3.0 has to be installed on the
FLOW Primary Sample Handling Instrument or on the FLOW PCR Setup Instrument depending on
which FLOW configuration is used.
This Operator’s Guide is to be used in combination with the following guides:
The FLOW Software Guide
The FLOW Solution User Training Guide
The MagNA Pure 96 System Operator's Guide
The MagNA Pure 96 System User Training Guide
The LightCycler® 480 Instrument Operator's Manual,
and/or cobas® 4800 User Defined Workflow (UDF) - User Guide
The Instructions for Use / Method Sheets for specified MagNA Pure 96 Kits
The Instructions for Use / Method Sheets for specified LightCycler® 480 Reagents
Every effort has been made to ensure that all the information contained in the Operator’s Guide is correct
at the time of publishing. However, Roche Diagnostics GmbH reserves the right to make any changes
necessary without notice as part of ongoing product development.
The screenshots and hardware images in this publication have been added exclusively for illustration
purposes. Configurable and variable data in screenshots, such as tests, results, or path names visible
therein must not be used for laboratory purposes.
3 Copyright
© Copyright 2021, Roche Diagnostics GmbH.
Information in this document is subject to change without notice. No part of this document may be
reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose,
without the express written permission of Roche Diagnostics GmbH.
Questions or comments regarding the contents of this Operator’s Guide can be directed to your local
Roche representative.
4 Trademarks
LIGHTCYCLER, COBAS, COBAS Z and MAGNA PURE are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
FLOW Primary Sample Handling and PCR Setup, Operator’s Guide Version 6.0
Contact addresses
10
II Contact addresses
III Approvals
Manufacturer Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
Distribution Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
Instrument approvals The FLOW PCR Setup System meets the requirements laid down in:
Directive 2014/30/EU of the European Parliament and Council of 26 February
2014 relating to electromagnetic compatibility (EMC).
Directive 2014/35/EU of the European Parliament and Council of 26 February
2014 relating to electrical equipment designed for use within certain voltage
limits.
Compliance with the applicable directive(s) is provided by means of the
Declaration of Conformity.
Regulatory compliance is demonstrated by the following mark:
Complies with European Union (EU) Directive 2004/108/EC and 2006/95/EC.
Complies with safety standards in Canada and USA tested by NRTL Tüv Süd (NRTL
= National Recognized Test Laboratory)
Equipment de
Laboratoire /
Laboratory Equipment
Equipment de Laboratoire / Laboratory Equipment
Prologue
Warranty
11
IV Warranty
The warranty conditions are specified in the sales contract. Contact your local Roche representative for
further information.
Any unauthorized modification of the FLOW PCR Setup Instrument and/or the FLOW PCR Setup/
FLOW Primary Sample Handling Instrument Software will result in the invalidation of the guarantee
and service contract.
V Intended use
The FLOW PCR Setup System is a liquid handler for aspirating and dispensing liquids.
The FLOW PCR Setup System is intended for general laboratory use and must be used exclusively by
professional users trained in laboratory techniques and having studied the user documentation of this
instrument.
VI Preamble
Before setting up operation of the FLOW PCR Setup Instrument, it is important to read the user
documentation thoroughly and completely. Non-observance of the instructions provided or performing
any operations not stated in the user documentation could produce safety hazards.
VII Contents of this Operator’s Guide
This Operator’s Guide describes the operation of the FLOW PCR Setup System. It contains the following
chapters:
Chapter A Overview presents the specifications of the FLOW PCR Setup System.
Chapter B System description contains the installation requirements of the
FLOW PCR Setup Instrument and a description of the system's components and disposables.
Chapter C Software describes the FLOW PCR Setup/FLOW Primary Sample Handling Software
functions in detail.
Chapter D Maintenance and care describes the maintenance and care procedures required for the
FLOW PCR Setup Instrument.
Chapter E Troubleshooting provides troubleshooting and error code information for the
FLOW PCR Setup Instrument, accessories, and disposables.
Chapter F Appendix contains the index and glossary.
FLOW Primary Sample Handling and PCR Setup, Operator’s Guide Version 6.0
Conventions used in this guide
12
VIII Conventions used in this guide
Text Conventions
To present information consistently and make it easy to read, the following text conventions are used in
this guide:
Abbreviations
For more information, see section Glossary, on page 157.
Product names
The FLOW Solution is compatible with the LightCycler® 480 Instrument, the cobas z 480
analyzer (UDF), and a combination of both for qPCR analysis. In all configurations, the same software
version operates the respective qPCR instrument.
In the following sections, this document references the LightCycler® 480 Instrument only to facilitate
readability.
Due to different hardware specifications (filter set, lamp unit, block format) for the
cobas z 480 analyzer compared to the LightCycler® 480 Instrument, generated results are not
identical. For details on the specifications, refer to the respective Operator's Manuals.
Symbols
In this Operator’s Guide the following symbols are used as visual signals:
Numbered list Steps in a procedure that must be performed in the order listed.
Italic type Used for operating instructions for the FLOW Primary Sample Handling and
PCR Setup Software. In addition, important notes and information notes are shown
in italics.
Blue italic type Refers to a different section in this guide that should be consulted.
[ ] Square brackets indicate keys on the keyboard.
< > Angle brackets indicate variables to be replaced with appropriate values.
Symbol Meaning Description
WARNING This symbol indicates that non-compliance with instructions or
procedures could lead to physical injury or even death or could
cause damage to the instrument.
HOT SURFACE This symbol is used to label potentially hot instrument surfaces.
BIO HAZARD This symbol indicates that certain precautions must be taken
when working with potentially infectious material.
DANGEROUS ELECTRICAL
VOLTAGE
This symbol indicates the danger of personal injury due to
dangerous electrical voltage. Refers to an imminent danger that
may result in death or serious personal injury.
ULTRAVIOLET LIGHT This symbol indicates that the FLOW PCR Setup Instrument
contains high-energy ultraviolet lamps that can cause serious
temporary or persistent eye and skin irritation. Never expose
unprotected eyes or skin to the UV light.
LASER BEAM This symbol indicates the presence of a class 2 laser.
Prologue
Conventions used in this guide
13
Symbols used on the instrument or components of the control unit
IMPORTANT NOTE This symbol indicates information critical to the success of the
procedure or use of the product.
INFORMATION NOTE This symbol indicates additional information about the current
topic or procedure.
This symbol indicates a procedure to be continued on the next
page.
This symbol indicates the end of a procedure.
Symbol Meaning Description
MANUFACTURER OF
DEVICE
On the instrument type plate.
CE MARK The CE mark on the instrument type plate indicates conformity
with requirements of the directives relevant for this instrument.
c TUV us On the instrument type plate.
China RoHS Mark On the instrument type plate.
ULTRAVIOLET LIGHT On the vertical cover, in the middle, and on the UV lamp.
LASER BEAM Indicates the presence of a class 2 laser.
On the autoload.
DANGEROUS ELECTRICAL
VOLTAGE
On the left side of the instrument near the power connection.
BIO HAZARD On the left side of the vertical cover and on the waste station.
HOT SURFACE On the UV lamp.
WARNING On the right side of the vertical cover.
Robotic arm: Moving arm inside cover; aborts the run if the
cover is opened. Do not move the robotic arm by hand.
Connection to PC: Use only the appropriate shielded cables.
USB connection: Having a total cable distance of more than
5 m, signals can be interfered.
WEEE Electrical and electronic equipment marked with this symbol is
covered by the European directive WEEE.
The symbol denotes that the equipment must not be disposed
of in the municipal waste system.
Symbol Meaning Description
FLOW Primary Sample Handling and PCR Setup, Operator’s Guide Version 6.0
Warnings and precautions
14
IX Warnings and precautions
In an emergency, immediately press the main switch on the front of the instrument to switch the
instrument off.
This instrument is an electromechanical device that could cause electric shock or injury if not operated
according to the procedures described in this Operator's Guide.
Failure to comply with the instructions in this Operator's Guide will void the manufacturer’s warranty
and may expose the operator to danger.
It is essential that the following safety information required for installation and operation of the
instruments is carefully read and observed. Please ensure that this safety information is accessible to all
personnel working with the FLOW PCR Setup System. A copy of this guide is available on the control
unit of the instrument and is accessible for all operators.
The trained Roche Service representative, the trained application specialist, and the laboratory adminis-
tration share the responsibility for the installation qualification and the operation qualification, that is,
verification and training. The process qualification is the sole responsibility of the laboratory.
1 Handling precautions
Do not let water or chemicals come into contact with any electrical components. Water or
chemicals may cause damage and will void your warranty.
Unplug the equipment if it will not be used for extended periods of time.
When using the equipment, follow generally accepted procedures for quality control and
method development.
Do not attempt to disassemble the equipment. Repairs must be performed by a trained
Roche Service representative. The equipments contain no operator-serviceable
parts.
Do not modify any part of the equipment. Modification may cause fire or malfunction, or
may void the manufacturer’s warranty.
Use only original FLOW PCR Setup Instrument specific parts and tools, for example,
carriers, trays, tips, and waste bags. Commercially available liquid vessels, such as primary
tubes, may of course be used.
Do not change or modify the pipetting routines provided in the FLOW PCR Setup/
FLOW Primary Sample Handling Software. This will lead to malfunction of the
FLOW PCR Setup Instrument.
Do not place your hands into the instrument when it is switched on.
Follow all safety instructions printed on or attached to the instrument.
Observe all general safety precautions that apply to electrical instruments.
Do not access any electrical parts while the instrument is connected to the mains.
Never touch switches or power cord with wet hands.
Always wear safety goggles and gloves when dealing with toxic, caustic or infectious
materials.
Make sure the main switch is freely accessible.
Warning of electric shock. Keep all covers closed while the instruments are connected to
the main power supply.
Spraying liquid on electrical parts can cause a short circuit and result in fire. Keep the
covers closed while the instruments are connected to the main power and do not use
spray in the vicinity of the instruments.
Warning of explosion from sparks. Keep all potentially inflammable or explosive material
(for example, anesthetic gas) away from the instruments.
The instruments contain high-energy ultraviolet lamps that can cause serious temporary or
persistent eye and skin irritation. Never expose unprotected eyes or skin to the UV light.
Prologue
Warnings and precautions
15
2 General precautions
The FLOW PCR Setup Instrument is designed to ensure safe operation. However, since biological sample
material may be processed in the instruments, there is a possible risk of infection. Therefore, when
handling potentially infectious material, always follow standard safety procedures and bear in mind the
following steps to minimize the chance of contamination or infection.
The instruments should not be used to analyze infectious materials unless additional safety measures
to ensure safe sample handling (for example, placing the instrument in a laboratory with the
appropriate safety level, or using a sample handling protocol that allows external sample lysis) are
taken beforehand.
Do not allow reagents containing guanidine thiocyanate to contact sodium hypochlorite (bleach)
solution or acids. These mixtures produce a highly toxic gas.
Wear disposable gloves, laboratory coats, and eye protection when handling specimens and reagents.
Immediately disinfect spills with an appropriate disinfectant solution to avoid spreading contamina-
tion to laboratory personnel or equipment.
If you are handling infectious, potentially infectious or any other dangerous material on the
instruments, you must follow your country-specific guidelines and national, federal, state and local
regulations.
Discard unused reagents and waste (solid and liquid) in accordance with national, federal, state and
local regulations.
Safety Data Sheets (SDS) are available online at www.e-labdoc.roche.com, or upon request from the
local Roche office.
After sample preparation is complete, remove and autoclave all disposables if you were working with
infectious sample material.
If this guide deviates from your national guidelines in any way, always follow your national guide-
lines. This may mean, for example, that you must use additional or alternative disinfectants or
cleaning methods.
All biological material is to be regarded as potentially infectious. Handling and disposal of
such material should be performed according to local safety guidelines. Spills should be
immediately disinfected with an appropriate disinfectant solution to avoid spreading
contamination to laboratory personnel or equipment.
For instructions for cleaning the FLOW PCR Setup Instrument, see chapter Maintenance
and care, on page 123.
The UV lamp is hot while the instrument is operating. Do not touch the housing of the
UV lamp.
Do not stare into the laser beam or view it directly with optical instruments.
FLOW Primary Sample Handling and PCR Setup, Operator’s Guide Version 6.0
Warnings and precautions
16
Loading
Do not overfill reagent containers, tubes, or other liquid containers. Ensure that there is no foam on
the surface of the liquid. Foam may cause pipetting problems.
Do not fill up partially consumed tip trays with tips from other trays. Tip trays should be loaded into
the Rack-TIP-CAR-480-A00 for 480 tips as they are provided in the original package. The tip trays are
individually labeled with a barcode for identification.
Work routine
All disposables are intended for single use only. Never use a disposable more than once (even after
cleaning it) as this would lead to unexpected and unreliable results.
Do not leave tips on the pipetting channels for a long period of time (for example, overnight). A daily
maintenance procedure will remove the tips. For more information, see section Operator mainte-
nance, on page 123.
Disinfection and decontamination
Do not use disinfecting materials that contain hypochlorite (Javel water, Chlorox) or bleaching
fluids.
For sole disinfection purposes, you may use commercially available disinfection reagents (please con-
tact the respective distributors in your country for more information). To remove DNases and/or
RNases, use a suitable decontamination reagent such as LTK-008, and afterwards wipe with water.
Be aware that decontamination agents do not disinfect. Please follow the instructions of the respec-
tive manufacturer. For more information on decontamination, see section Operator maintenance,
on page 123.
After cleaning and disinfecting, decontaminate the instrument using the built-in UV lamps. For more
information on UV decontamination, see section To decontaminate the instrument with the UV lamp, on
page 134.
The FLOW PCR Setup Instrument is not a fully airtight device. Therefore the instrument does not
have the same functionality as a laminar flow biological safety cabinet and should not be used for
analysis of infectious sample material that can be transmitted by air, unless additional safety mea-
sures ensure safe sample handling.
Make sure the main switch of the FLOW PCR Setup Instrument is freely accessible.
Incorrect location of the FLOW PCR Setup Instrument can cause incorrect results and damage to
the equipment parts. Moving the instrument must be performed only by qualified
Roche service personnel.
Danger of explosion through sparks. Keep all potentially inflammable or explosive material
(for example, anesthetic gas) away from the FLOW PCR Setup Instrument.
Spraying liquid on electrical parts can cause a short circuit and result in a fire.
Do not use sprays in the vicinity of the instrument. During firefighting operations, disconnect
the instrument from the mains.
Do not manipulate the FLOW PCR Setup Instrument.
Prologue
Warnings and precautions
17
3 About software and data security
The FLOW PCR Setup System contains software that allows the operator of the product to connect
it to a network when operated within the FLOW Solution. Roche hereby informs the operator that
such a connection may have an adverse effect on the product’s integrity, for example, if the product
were infected with malicious code (viruses, Trojan horses, etc.) or accessed by unauthorized third
parties, such as intrusion by hackers.
Data loss or unavailability of the system due to malicious software or unauthorized system
access
To avoid infection by malicious software or the unauthorized access and misuse of the FLOW PCR Setup
System operated within the FLOW Solution, follow these recommendations:
Do not install and/or run any other software on the FLOW PCR Setup System.
Make sure other computers and services on the network, for example, the LIS, archiving or backup
share, are properly secured and protected against malicious software and unauthorized access.
Customers are responsible for the security of their local area network, especially in protecting it
against malicious software and attacks. This protection might include measures, such as a firewall,
to separate the device from uncontrolled networks as well as measures that ensure that the
connected network is free of malicious code.
A firewall is mandatory; the Roche-provided firewall is recommended.
Make sure that system backup and archive files are protected from any unauthorized access and
disaster, this includes: remote storage location, disaster recovery sites, and secure transfer of
backup files.
Roche offers the operator the Roche firewall to be installed before the initial connection of the product to
any network. For further information on this firewall and/or the Roche network security concept, contact
your local Roche representative. In the event the user connects the product with any network without
using a Roche firewall, Roche cannot offer any product support regarding any problem resulting from
such network connection.
Attached systems
Loss of data integrity or unavailability of the system can occur due to malicious software or unauthorized
system access. To avoid infection of malicious software or the unauthorized misuse of the system, follow
these recommendations:
Check all external storage devices such as CDs, DVDs, or USB flash drives with an anti-virus scan-
ner (on another computer) to ensure that they are free of malicious software, before using them on
the system.
Make sure other computers and services on the network (e.g., the host, archiving/backup share or
service) are properly secured and protected against malicious software and unauthorized access.
Compromised system
Malicious software or unauthorized system access can result in loss of data integrity or unavailability of
the system. Typical signs of malicious software or unauthorized access to the system include:
Unexpected warning messages from the instrument.
Unexpected new files in working folders.
Unexpected audit trail and system log entries like multiple failed logon attempts.
Significantly degraded user interface performance.
Seemingly random crashes of the system.
Automated typing of text, automatic cursor movement etc.
FLOW Primary Sample Handling and PCR Setup, Operator’s Guide Version 6.0
Disposal of the instrument
18
Monitor the system for suspicious activity and report suspected compromise. If you suspect malicious
activity on the system:
Physically disconnect the system from the network.
Contact the laboratory IT responsible to report and verify the finding.
Mistrust results produced while the system has been compromised (if necessary, re-verify already
released results).
Contact a Roche representative to initiate next steps in system recovery.
Unauthorized access due to careless password handling
Disclosing passwords may lead to unauthorized system access.
Always use strong passwords.
Do not disclose passwords to unauthorized users.
4 Electrical safety
Observe the warnings regarding interactions and non-recommended functions. Also bear in mind
the potential scope for misuse; it is advisable to draw attention to the possible consequences.
X Disposal of the instrument
Disposal recommendations
The FLOW PCR Setup Instrument is designed in accordance with Protection Class I (IEC). The
chassis/housing of each instrument is connected to protection earth (PE) by a cable. For
protection against electric shock hazards, the instruments must be directly connected to an
approved power source such as a three-wire grounded receptacle for the 115/230 V line.
Where only an ungrounded receptacle is available, a qualified electrician must replace it with
a properly (PE) grounded receptacle in accordance with the local electrical code. No
extension must be used.
Any break in the electrical ground path, whether inside or outside the instrument, could
create a hazardous condition. Under no circumstances should the operator attempt to modify
or deliberately override the safety features of the instrument. If the power cable becomes
cracked, frayed, broken, or otherwise damaged, it must be replaced immediately with the
equivalent part from Roche Diagnostics.
The FLOW PCR Setup Instrument must be treated as biologically contaminated hazardous
waste. Decontamination (that is, a combination of processes, including cleaning, disinfection,
and/or sterilization) is required before reuse, recycling, or disposal.
Dispose of the instrument according to local and/or laboratory regulations.
For more information, contact your local Roche representative.
Disposal of control unit components
This symbol appears on any component of your control unit (such as the computer, monitor,
or keyboard) that is covered by the European Directive on Waste Electrical and Electronic
Equipment (WEEE).
You must dispose of these items through designated collection facilities appointed by
government or local authorities.
Contact your city office, waste disposal service, or your trained Roche Service representative
for more information about disposal of your old product.
Constraint:
It is left to the responsible laboratory organization to determine whether control unit
components are contaminated or not. If contaminated, treat them in the same way as the
instrument.
Overview
Introduction
19
A
A
Overview 0
1 Introduction
The FLOW PCR Setup System can be used in two different modes:
As a primary sample handling component when using the
FLOW Primary Sample Handling Software.
As a PCR setup component, when using the FLOW PCR Setup Software.
FLOW Primary Sample Handling mode:
The FLOW PCR Setup System in Primary Sample Handling mode performs primary sample handling in
two different configurations:
In the FLOW configuration, the FLOW PCR Setup System in Primary Sample Handling mode is used
in combination with the FLOW Solution. The FLOW Solution provides an automated solution for a
laboratory workflow comprising primary sample handling, purification, PCR setup, and qPCR.
In the standalone configuration, the FLOW PCR Setup System in Primary Sample Handling mode is
used with the MagNA Pure 96 System. This combination provides an automated solution for a
laboratory workflow comprising primary sample handling and nucleic acid purification.
In Primary Sample Handling mode the FLOW PCR Setup System can pipette up to 256 samples from pri-
mary or secondary sample tubes into MagNA Pure 96 Processing Cartridges, depending on the configu-
ration. The system can handle multiple sample types simultaneously (after respective pretreatment).
FLOW PCR Setup mode:
The FLOW PCR Setup System in PCR Setup mode performs pipetting operations on liquids from
secondary tubes and MagNA Pure 96 Output Plates to LightCycler® 480 Multiwell Plates (either 96 or
384 well format).
Pipetting means transferring small quantities of liquid from one vessel to another. A pipetting operation
is achieved by aspirating liquid from a source vessel, then transferring and dispensing it into the target
vessel.
The FLOW PCR Setup System in PCR Setup mode is used in combination with the FLOW Solution.
The FLOW Solution provides an automated solution for a laboratory workflow comprising primary
sample handling, purification, PCR setup, and qPCR.
The FLOW PCR Setup Instrument can pipette multiple components to prepare different qPCR reaction
mixes. After dispensing the reaction mix into the LightCycler® 480 Multiwell Plate(s), the
FLOW PCR Setup Instrument transfers eluates and optional controls, standards and calibrators from
MagNA Pure 96 Output Plates and FLOW Tubes (2ml) to the reaction mix in the LightCycler® 480
Multiwell Plate(s). The FLOW PCR Setup Instrument can process Ready to Use Mixes as well as reaction
mixes created from single components.
FLOW Primary Sample Handling and PCR Setup, Operator’s Guide Version 6.0
20
Introduction
A
AFor further details on alternative FLOW Solution configurations, refer to the FLOW Software Guide.
The FLOW Primary Sample Handling Instrument, Cat. No. 07101937001, has been replaced by the
FLOW PCR Setup Instrument, Cat No. 07101996001, since 2018. The only difference between these
2 instruments is that the FLOW Primary Sample Handling Instrument has only 4 pipetting channels
while the FLOW PCR Setup Instrument has 8 pipetting channels. All other hardware feature are the
same.
Only 4 pipetting channels are used for the sample transfer regardless of which instrument is used for
the primary sample handling.
The FLOW Primary Sample Handling Software Version 3.0 has to be installed on the
FLOW Primary Sample Handling Instrument or on the FLOW PCR Setup Instrument depending on
which FLOW configuration is used.
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Roche FLOW PCR Setup User manual

Roche
Brand
Roche
Model
FLOW PCR Setup
Type
User manual
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