Roche FLOW PCR Setup User manual

Roche
Brand
Roche
Model
FLOW PCR Setup
Type
User manual
FLOW PCR Setup System Operator's Guide
For general laboratory use.
F
LOW Software
Addendum 1 to the FLOW PCR Setup System
Operator’s Guide Version 5.0
Software Version 2.1 May 2020
For general laboratory use
Addendum 1 to the FLOW PCR Setup System Operator’s Guide Version 5.0
Updated Information about the FLOW Solution
Dear Valued User of the FLOW Solution,
The following information updates the content provided in the FLOW Solution Operator`s Manual Version 4.0
and FLOW PCR Setup System Operator’s Guide Version 5.0.
New feature available:
It is now possible to use 1.5 ml tubes instead of 2 ml FLOW Tubes on the PCR Setup System (PSU) in combination
with the FLOW 32 Vial Carrier. The following applies to the new feature:
c
All 32 positions remain available.
c All Reagent/Control/Standard/Calibrator types defined in the FLOW Software Guide, chapter PCR database
configuration, can be processed with 1.5 ml tubes with maximum volume of 1.4 ml liquid.
For ready to use Master Mix, the maximum volume is 1.4 ml per tube.
For reaction mix created from single components on the PSU in the 1.5 ml configuration, the follow limitations
apply:
The reaction mix, including safety volume, must not exceed 1.4 ml when a reaction mix is created from
single components in the 1.5 ml configuration. If the final amount of reaction mix to be prepared by the PSU
exceeds this limit, there is a high risk of spillage in the instrument as the instrument will attempt to pipette
more than the maximum amount in the tube.
Therefore, in the case of 15 µl reaction mix per sample, it is only possible to prepare a reaction mix for up to
40 samples. If more than 40 samples are order for a single reaction mix prepared on board, the 1.5 ml will be
overfilled and liquid will spill into the instrument.
c
Validated tube type: Sarstedt Cat. No. 72.703.406
No other 1.5 ml tube types are validated on the PSU.
The Sarstedt 1.5 ml tube cannot be used on the Primary Sample Handling System (PSH) or the FLOW PCR
Setup System in Primary Sample Handling mode.
All PSU Software messages will refer to 2 ml FLOW tubes, regardless of the tube type that has been defined in
the configuration. If the system has been configured for 1.5 ml tubes, ensure that all users are informed about
the change and use only 1.5 ml tubes on the system.
The settings file on the PSU Control Unit must be updated to enable the use of 1.5 ml tubes. Only one tube type,
1.5 ml or 2 ml, can be chosen, and the setting can only be adjusted by a Roche Service representative.
Contact your Roche representative for more information about implementing this new feature
on the PSU.
Updated Information about the FLOW Solution
Published by
Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
© 2020 Roche Diagnostics.
3
0220
For general laboratory use.
The FLOW Solution is not available in all territories due to different national regulations.
This document is not intended for use in the USA.
FLOW PCR Setup System Operator's Guide
Version 5.0, Software Version 2.1 March 2018
For general laboratory use.
FLOW PCR Setup Instrument, Operator’s Guide Version 5.0
Table of contents
2
Prologue 6
I Document information ................................................................................................................................6
1 Revision history .................................................................................................................................................. 6
2 Edition notice ...................................................................................................................................................... 7
3 Copyright .............................................................................................................................................................. 7
4 Trademarks .......................................................................................................................................................... 7
II Contact addresses ........................................................................................................................................ 8
III Approvals ............................................................................................................................................................ 8
IV Warranty .............................................................................................................................................................. 9
V Intended use ..................................................................................................................................................... 9
VI Preamble ............................................................................................................................................................. 9
VII Contents of this Operator’s Guide ........................................................................................................ 9
VIII Conventions used in this guide ............................................................................................................ 10
IX Warnings and precautions ...................................................................................................................... 12
1 Handling precautions ..................................................................................................................................... 12
2 General precautions ....................................................................................................................................... 13
3 About software and data security ............................................................................................................. 15
4 Electrical safety ................................................................................................................................................. 16
X Disposal of the instrument ..................................................................................................................... 16
A Overview 17
1 Introduction ..................................................................................................................................................... 17
2 Specifications of the FLOW PCR Setup Instrument ................................................................. 18
2.1 General specifications ................................................................................................................................... 18
2.1.1 Shipping .............................................................................................................................................................. 18
2.1.2 Environmental requirements ....................................................................................................................... 18
2.2 Technical specifications ................................................................................................................................ 19
2.3 Specifications of the barcode readers ..................................................................................................... 20
2.4 Barcode specifications .................................................................................................................................. 21
2.5 Specifications for LIMS ................................................................................................................................. 22
2.6 Uninterruptible power supply ..................................................................................................................... 22
B System description 23
1 The FLOW PCR Setup System ............................................................................................................... 23
1.1 The FLOW PCR Setup Instrument ............................................................................................................. 23
1.1.1 Front view ........................................................................................................................................................... 24
1.1.2 Back of the instrument .................................................................................................................................. 26
1.1.3 Sides of the instrument ................................................................................................................................. 27
1.2 Main components ........................................................................................................................................... 28
1.2.1 Modular robotic arm ...................................................................................................................................... 28
1.2.2 1000 µl pipetting channels ........................................................................................................................... 29
1.2.3 Autoload .............................................................................................................................................................. 30
1.2.4 CO-RE grip ......................................................................................................................................................... 32
1.2.5 Teaching needles ............................................................................................................................................ 33
1.2.6 Waste station ..................................................................................................................................................... 34
1.2.7 Deck layout ........................................................................................................................................................ 34
1.3 Disposables ........................................................................................................................................................ 39
1.4 Accessories ........................................................................................................................................................ 42
Table of contents
3
1.5 Custom primary/secondary tubes ............................................................................................................. 45
1.5.1 Sample types ..................................................................................................................................................... 46
1.5.2 Sample volumes ............................................................................................................................................... 47
1.5.3 Reagent types ................................................................................................................................................... 48
1.5.4 Reagent volumes ............................................................................................................................................. 48
2 Installation ....................................................................................................................................................... 49
2.1 Installation requirements .............................................................................................................................. 49
2.2 Technology ........................................................................................................................................................ 49
C Software 52
1 General software conventions ............................................................................................................. 52
1.1 Buttons ................................................................................................................................................................ 52
1.2 Working with tables ....................................................................................................................................... 52
2 FLOW PCR Setup System in Primary Sample Handling mode ........................................... 54
2.1 Starting the software ..................................................................................................................................... 54
2.2 The main window ............................................................................................................................................ 55
2.2.1 Information bar ................................................................................................................................................ 55
2.2.2 Working window area ................................................................................................................................... 56
2.2.3 Global action bar ............................................................................................................................................. 57
2.2.4 Status bar ........................................................................................................................................................... 58
2.3 Closing the software ...................................................................................................................................... 58
3 Standalone configuration ....................................................................................................................... 59
3.1 Run with individual run parameters ......................................................................................................... 59
3.1.1 Run parameters ............................................................................................................................................... 59
3.1.2 Open/Close vertical cover message box ................................................................................................ 62
3.1.3 Please load deck as specified below dialog box ................................................................................. 63
3.1.4 Sample loading results .................................................................................................................................. 64
3.1.5 Edit Tip Count dialog box ............................................................................................................................. 66
3.1.6 Insufficient Liquid message box ................................................................................................................ 67
3.1.7 Internal Controls message box .................................................................................................................. 68
3.1.8 Processing view ............................................................................................................................................... 68
3.1.9 End of run .......................................................................................................................................................... 70
3.1.10 Data transfer to the MagNA Pure 96 Instrument ............................................................................... 72
3.2 Run with worklist ............................................................................................................................................. 72
3.2.1 Worklist file selection ..................................................................................................................................... 72
3.2.2 Run parameters ............................................................................................................................................... 73
3.2.3 Please load deck as specified below dialog box ................................................................................. 74
3.2.4 Open/Close vertical cover message box ................................................................................................ 74
3.2.5 Sample loading results .................................................................................................................................. 75
3.2.6 Edit Tip Count dialog box ............................................................................................................................. 76
3.2.7 Insufficient Liquid message box ................................................................................................................ 76
3.2.8 Internal Controls message box .................................................................................................................. 76
3.2.9 Processing view ............................................................................................................................................... 76
3.2.10 End of run .......................................................................................................................................................... 76
3.2.11 Data transfer to the MagNA Pure 96 System ....................................................................................... 76
4 FLOW configuration ................................................................................................................................... 77
4.1 FLOW Worklist overview ............................................................................................................................... 77
4.2 Please load deck as specified below dialog box ................................................................................. 79
4.3 Open/Close vertical cover message box ................................................................................................ 79
4.4 Sample loading results .................................................................................................................................. 80
4.5 Edit Tip Count dialog box ............................................................................................................................. 82
4.5.1 IC has run out please continue to refill IC message box ................................................................. 82
4.5.2 Please refill the labware positions with IC liquid of barcode message box .............................. 83
4.6 Processing view ............................................................................................................................................... 83
4.7 Process Samples Review .............................................................................................................................. 84
4.8 End of run .......................................................................................................................................................... 85
4.9 Data transfer ..................................................................................................................................................... 85
FLOW PCR Setup Instrument, Operator’s Guide Version 5.0
Table of contents
4
5 Aborting a run ................................................................................................................................................ 86
5.1 Operator-controlled abort ............................................................................................................................ 86
5.2 Instrument-controlled abort ........................................................................................................................ 86
5.3 Emergency shutdown .................................................................................................................................... 86
6 Administrative tasks .................................................................................................................................. 87
6.1 User management ........................................................................................................................................... 87
6.2 Worklists ............................................................................................................................................................. 87
6.2.1 FLOW configuration ........................................................................................................................................ 87
6.2.2 Standalone configuration ............................................................................................................................. 87
6.3 Application Configuration Editor ............................................................................................................... 89
6.4 Order templates for MagNA Pure 96 Software .................................................................................... 92
6.5 Network interaction ........................................................................................................................................ 92
7 FLOW PCR Setup System in PCR Setup mode ............................................................................ 93
7.1 Starting the software ...................................................................................................................................... 93
7.2 The main window ............................................................................................................................................ 93
7.2.1 Information bar ................................................................................................................................................. 94
7.2.2 Working window area .................................................................................................................................... 94
7.2.3 Global action bar ............................................................................................................................................. 94
7.2.4 Status bar ........................................................................................................................................................... 95
7.3 Closing the software ....................................................................................................................................... 95
8 PCR Setup FLOW configuration ........................................................................................................... 96
8.1 Settings ................................................................................................................................................................ 96
8.2 PCR Test Setup Overview ............................................................................................................................. 97
8.2.1 Reaction Mix Preparation - Overview tab .............................................................................................. 97
8.2.2 Transfer Reaction Mixes - Overview tab ................................................................................................. 98
8.2.3 Transfer RT Mixes - Overview tab ............................................................................................................. 99
8.3 PCR Test Setup Execute ................................................................................................................................ 99
8.3.1 Processing view ............................................................................................................................................. 100
8.3.2 Open/Close vertical cover message box .............................................................................................. 101
8.3.3 Load tips message box ............................................................................................................................... 102
8.3.4 Edit Tip Count dialog box .......................................................................................................................... 102
8.3.5 Load Reagents message box ................................................................................................................... 104
8.3.6 Missing Tubes message box .................................................................................................................... 105
8.3.7 Load labware message box ...................................................................................................................... 105
8.3.8 Successfully processed message box ................................................................................................... 106
8.4 PCR Test Setup Review .............................................................................................................................. 106
8.4.1 Reaction Mix Preparation - Review tab ............................................................................................... 106
8.4.2 Transfer Reaction Mixes - Review tab .................................................................................................. 107
8.4.3 Transfer RT Mixes - Review tab .............................................................................................................. 109
8.4.4 Continue button ............................................................................................................................................ 109
8.5 PCR Sample Transfer Overview ............................................................................................................... 110
8.5.1 Transfer Samples - Overview tab ........................................................................................................... 110
8.5.2 Transfer Controls - Overview tab ............................................................................................................ 111
8.6 PCR Sample Transfer Execute ................................................................................................................. 111
8.6.1 Unload of Carriers message box ............................................................................................................ 112
8.6.2 Open/close vertical cover message box .............................................................................................. 112
8.6.3 Load Controls message box ..................................................................................................................... 112
8.6.4 Load labware message box ...................................................................................................................... 112
8.6.5 Load tips message box ............................................................................................................................... 112
8.6.6 Edit Tip Count dialog box .......................................................................................................................... 113
8.6.7 Successfully processed message box ................................................................................................... 113
8.7 PCR Sample Transfer Review ................................................................................................................... 113
8.7.1 Transfer Samples - Review tab ............................................................................................................... 113
8.7.2 Transfer Controls - Review tab ................................................................................................................ 114
8.8 End of run ........................................................................................................................................................ 115
9 Aborting a run ............................................................................................................................................. 116
9.1 Operator-controlled abort ......................................................................................................................... 116
9.2 Instrument-controlled abort ..................................................................................................................... 116
9.3 Emergency shutdown ................................................................................................................................. 116
Table of contents
5
10 Administrative tasks ................................................................................................................................ 117
10.1 User management ........................................................................................................................................ 117
10.2 Worklists ........................................................................................................................................................... 117
10.3 Network interaction ...................................................................................................................................... 117
D Maintenance and care 118
1 Operator maintenance ............................................................................................................................ 118
1.1 Starting and aborting a maintenance routine .................................................................................... 119
1.2 Daily maintenance ........................................................................................................................................ 121
1.3 Weekly maintenance .................................................................................................................................... 124
1.4 Report file ......................................................................................................................................................... 128
1.5 On-demand maintenance .......................................................................................................................... 129
2 Service maintenance ............................................................................................................................... 137
E Troubleshooting 138
1 Startup problems ....................................................................................................................................... 138
2 Problem report ............................................................................................................................................ 138
3 Remote service ........................................................................................................................................... 139
4 Run-time error handling ........................................................................................................................ 140
4.1 Vertical Cover - Error ................................................................................................................................... 140
4.2 Identify carrier - Error .................................................................................................................................. 141
4.3 Barcode error .................................................................................................................................................. 142
4.3.1 User Input dialog box (PCR Setup Software specific) ..................................................................... 142
4.3.2 Insert Barcode dialog box (Primary Sample Handling Software specific) ............................... 143
4.4 Tip loading errors .......................................................................................................................................... 143
4.5 1000 µl Channel Tip Pick Up - Error ...................................................................................................... 144
4.6 Maintenance interval error ........................................................................................................................ 145
4.7 Internal control error .................................................................................................................................... 145
5 Errors for primary sample transfer .................................................................................................. 147
6 Error data transfer ..................................................................................................................................... 148
7 Errors during PCR test setup and PCR sample transfer ...................................................... 149
8 Error handling concerning the UV decontamination ............................................................. 151
F Appendix 152
1 Glossary .......................................................................................................................................................... 152
F Index 160
FLOW PCR Setup Instrument, Operator’s Guide Version 5.0
Document information
6
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 intro-
duced
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, stan-
dards, 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 Pri-
mary Sample Handling
System content
Editorial corrections
Prologue
Document information
7
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.
This Operator’s Guide is to be used in combination with the following guides:
The FLOW Software Guide Version 4.0, November 2015
The FLOW Solution User Training Guide Version 4.0, November 2015
The MagNA Pure 96 System Operator's Guide Version 4.0, Dec 2017
The MagNA Pure 96 System User Training Guide Version 4.0, Dec 2017
The LightCycler® 480 Instrument Operator's Manual Version 4.0, Feb 2018,
and/or cobas® 4800 System Operator's Manual User Defined Workflow (UDF) Software Version 2.0
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 2018, 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 PCR Setup Instrument, Operator’s Guide Version 5.0
Contact addresses
8
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
9
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 PCR Setup Instrument, Operator’s Guide Version 5.0
Conventions used in this guide
10
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 152.
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 PCR Setup Instrument 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 SUR FACE This symbol is used to label potentially hot instrument surfaces.
BIO HAZ ARD 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
11
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
MANU FACTUR E R 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 ELECTRI-
CAL VOLTAGE
On the left side of the instrument near the power connection.
BIO HAZ ARD On the left side of the vertical cover and on the waste station.
HOT SUR FACE 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 PCR Setup Instrument, Operator’s Guide Version 5.0
Warnings and precautions
12
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
13
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 118.
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 PCR Setup Instrument, Operator’s Guide Version 5.0
Warnings and precautions
14
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 118.
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 118.
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 129.
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
15
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 LIMS, 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 fire-wall, 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.
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Roche FLOW PCR Setup User manual

Roche
Brand
Roche
Model
FLOW PCR Setup
Type
User manual
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