Roche FLOW SW User manual

FLOW Solution

For general laboratory use.

How to use the FLOW Solution Guides

Before reading, please review all Addenda for important information.

User Training Guide

Provides detailed step-by-step instructions for an exemplary routine operation using deﬁned and conﬁgured

experimental settings, including instrument startup and shutdown.

Software Guide

Provides a detailed description of all relevant software information not covered by the User Training Guide.

The following Operator’s Guides can be used in addition to the FLOW Solution Guides:

c FLOW Primary Sample Handling System Operator’s Guide

c MagNA Pure 96 System Operator’s Guide

c FLOW PCR Setup System Operator’s Guide

c LightCycler®

®

480 Instrument Operator’s Manual

c cobas

®

4800 System Operator’s Manual User Deﬁned Workﬂow (UDF) Software Version 2.0

Addenda

Provide updates to the FLOW Solution Guides, including new supplementary information and/or

corrections to previous editions.

For general laboratory use

FLOW Software

Addendum 3 to the FLOW Solution

Operator’s Manual Version 4.0

Software Version 2.1 May 2020

For general laboratory use

Addendum 3 to the FLOW Solution Operator’s Manual Version 4.0

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

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.

FL

OW Solution

Addendum 2 to the FLOW Solution

Operator’s Manual Version 4.0

Software Version 2.1

February 2018

For general laboratory use

2

FLOW Software

Updated Information about the FLOW Solution

Dear Valued User of the FLOW Solution,

The following information updates content provided in the FLOW Solution User Training Guide, Version 4.0,

and the FLOW Software Guide Version 4.0.

Updated Information about the FLOW Solution

3

Addendum 2 to the FLOW Solution Operator’s Manual Version 4.0

FLOW Solution User Training Guide

Chapter B – 1.2 Data Flow

The information for the entry “MP96” in the table Input and output data FLOW is corrected as shown below.

Output Plate is replaced by Processing Cartridge.

System Process Step File Sample Status

MP96 Creates a result ﬁle

and saves it to the

O:\MP96\Results directory.

barcode.xml

(Barcode of the MagNA Pure 96

Processing Cartridge)

Updated Information about the FLOW Solution

FLOW Solution User Training Guide

4

FLOW Software

FLOW Software Guide

Prologue

X - Warnings and precautions

Change 1

The Important Note at the beginning of this chapter is replaced by the following Important Note.

The FLOW Solution contains software that allows the operator of the product to connect it to a network. 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.

Change 2

The information described in the Prologue, Chapter X includes the following new information:

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 Solution, follow

these recommendations:

c

Do not install and/or run any other software on the FLOW Solution.

c 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.

c

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.

c

A ﬁrewall is mandatory; the Roche-provided ﬁrewall is recommended.

c 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:

c

Check all external storage devices such as CDs, DVDs, or USB ﬂash drives with an anti-virus scanner (on

another computer) to ensure that they are free of malicious software, before using them on the system.

c

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.

Updated Information about the FLOW Solution

FLOW Software Guide

5

Addendum 2 to the FLOW Solution Operator’s Manual Version 4.0

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:

c Unexpected warning messages from the instrument.

c Unexpected new ﬁles in working folders.

c Unexpected audit trail and system log entries like multiple failed logon attempts.

c Signiﬁcantly degraded user interface performance.

c Seemingly random crashes of the system.

c Automated typing of text, automatic cursor movement etc.

Monitor the system for suspicious activity and report suspected compromise. If you suspect malicious activity

on the system:

c Physically disconnect the system from the network.

c Contact the laboratory IT responsible to report and verify the ﬁnding.

c Mistrust results produced while the system has been compromised (if necessary, re-verify already released

results).

c 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.

c Always use strong passwords.

c Do not disclose passwords to unauthorized users.

c Do not write down passwords.

Updated Information about the FLOW Solution

FLOW Software Guide

6

FLOW Software

Chapter F - PCR database conﬁguration

F - 1. Basic PCR database concepts

F - 1.2 Control concept

The result description table is updated with the following entry:

Depending on the controls, the FLOW Software reports the following results:

Result Description

UNCERTAIN All template and process controls passed. The sample status could not

be called an obvious positive or negative. For further details, refer to the

LightCycler

®

480 Operator’s Manual.

F - 2. PCR Database Conﬁguration main window

The information described in the Chapter PCR Database Conﬁguration Main Window includes the following

new information:

With the exception of the “Eluate volume per PCR Test (µl)”, volume settings cannot have more than 1 digit

after the decimal point.

The “Eluate volume per PCR Test (µl)” setting is automatically rounded to a whole number if digits after the

decimal point are entered.

F – 13. Quantiﬁcation

The information described in the Chapter Quantiﬁcation includes the following new information:

For internal standard curves, the FLOW Software uses a non-linear (polynomial) regression line for calculation

of concentrations, if required. The display in the result screen shows a linear regression line. The link-value is

not displayed.

Do not use calculated concentrations based on extrapolated standard curve data for non-linear ﬁt curves.

Best practice is to set the ULQ to the highest concentrated standard value, and to use a standard curve that

covers the full range of the expected sample concentrations. Any samples with Cq results greater than the Cq

of the highest concentrated standard must be interpreted with special attention.

Updated Information about the FLOW Solution

F - PCR database conﬁguration

Published by

Roche Diagnostics GmbH

Sandhofer Straße 116

68305 Mannheim

Germany

2

0218

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.

LIGHTCYCLER, and MAGNA PURE are trademarks of Roche.

All other product names and trademarks are the property of their respective owners

FLOW Solution

Addendum 1 to the FLOW Solution

Operator’s Manual Version 4.0

Software Version 2.1 January 2017

For general laboratory use

2

FLOW Solution

Updated Information about the FLOW Solution

Dear Valued User of the FLOW Solution,

Please read the following updated information for the FLOW Software Guide Version 4.0.

A - Introduction:

Updated information on the deﬁnition of FLOW conﬁgurations:

c FLOW Classic consists of ﬁve individual components: one FLOW Primary Sample Handling System, one

MagNA Pure 96 System, one FLOW PCR Setup System, one LC480 Instrument, and one FLOW Software.

Alternatively, the FLOW Primary Sample Handling Instrument can be replaced with a second FLOW PCR

Setup Instrument running in primary sample handling mode.

FLOW Classic can be extended with up to three MagNA Pure 96 Systems and up to ﬁve LC480 Instruments

for increased throughput.

c In FLOW Flex, the FLOW PCR Setup System covers both primary sample handling and PCR setup workﬂow

steps. FLOW Flex results in slightly lower throughput, but a lower space requirement. FLOW Flex can be

upgraded to FLOW Classic if necessary.

As for FLOW Classic, FLOW Flex can also be extended with up to 3 MagNA Pure 96 Systems and up to ﬁve

LC480 Instruments.

c For parallel operation of two FLOW installations (FLOW Classic or FLOW Flex), the FLOW Fusion

application can be used.

A – 1.3 FLOW Software Installation:

New information on the possible hardware conﬁgurations of the FLOW Software control unit.

Hardware requirements:

FLOW Software 2.1. SP3 and higher will be delivered with a new HP rp5810 Control Unit, containing 8 Gb of

RAM and two separate hard disk drives (500 and 1,000 GB storage).

Existing installations can either switch to the new hardware standard, or update the current HP rp5800 Control

Units with the FLOW CU rp5800 UPGRADE PACKAGE (08 157 740 001).

For details on the content of the upgrade package, contact your local Roche representative.

Updated Information about the FLOW Solution

Introduction

3

Addendum 1 to the FLOW Solution Operator’s Manual Version 4.0

A – 2. Starting the FLOW Software

Preinstalled users

The User on Operating System Level has changed. The Roche-FSR-Admin account has been disabled; instead,

the following credentials must be used:

Operating level User Password

Microsoft Windows FLOWAdmin AdminF1OW

To start the FLOW Software:

Turn on the monitor and the control unit. The operating system is started. Log in to Microsoft Windows:

1

Click the FLOWAdmin icon

2

Enter the following password: AdminF1OW

3

Double-click the software icon on the desktop.

The FLOW Software main window opens and displays the login dialog box.

D – 2. Utilities – Archive Tab

Updated content of the Archive Conﬁguration Window.

Updated Information about the FLOW Solution

Starting the FLOW Software

4

FLOW Solution

D – 2.1 Archive options window area

Updated information on the archive options window area.

The following items have been changed:

Settings Description

Data kept in working database Amount of data to be kept in the current working database. The

archiving process will archive any data older than the set number of

days, weeks, or months, and remove them from the working database.

Include operator activity log Selection obsolete, always included

Remove archived records after transfer Selection obsolete, always removed

Compact databases Selection obsolete, always compacted

To be able to open and view archived databases created with previous software versions, the archived data-

bases need to be updated using the upgraded script (part of FLOW Software DVD). For further information

or assistance, contact your local Roche representative.

For periodic archives, the following prerequisites need to be considered:

1. FLOW Software has to be running for periodic archives to work.

2. Periodic archives create an archive of whichever database is active at the time.

To ensure full traceability, every change in the settings of the FLOW Software (e.g., addition/removal of

targets or controls, update of general settings, etc.) will enforce the creation of a new archive database instead

of merging it into the existing one.

Archives will contain all approved results. Any results within the speciﬁed timeframe which have not been

approved by the operator will remain in the working database.

Updated Information about the FLOW Solution

Utilities – Archive Tab

5

Addendum 1 to the FLOW Solution Operator’s Manual Version 4.0

F - PCR Database conﬁguration

F - 8 PCR Test

Updated information in the PCR Test window.

Setting Description

LightCycler® 480 Macro The browse button opens the Macros window where an additional

macro can be added by specifying the exact name and path.

c Macro Name: Specify the exact Macro name and path in the

LightCycler

®

480 Application Software.

c Macro Duration: Enter the approximate runtime of the macro (min)

to optimize the communication between the FLOW Software and

LightCycler

®

480 LIMS Module.

When updating existing databases, the new macro has to be deﬁned and linked to all relevant PCR Tests

before the old macro can be deleted.

Ensure the time deﬁned for the “Macro Duration” slightly exceeds the actual runtime of the experiment.

G – Backup and reporting

G – 1.2 Periodic backups

For periodic backups, the following prerequisites need to be considered:

1. FLOW Software has to be running for periodic backup to work.

2. Periodic backups create a backup of whichever database is active at the time.

K – Troubleshooting

K – 7. Fallback procedures:

Content of this chapter is obsolete and has been moved to a separate document, FLOW Solution Troubleshooting

Guide.

Updated Information about the FLOW Solution

PCR Database conﬁguration

6

FLOW Solution

L – Appendix

L – 1. Glossary

Updated deﬁnitions on:

FLOW Classic

FLOW Flex

FLOW Fusion

For details, see changes in A. Introduction.

FLOW Ultra: Deﬁnition obsolete

Updated Information about the FLOW Solution

Appendix

Published by

Roche Diagnostics GmbH

Sandhofer Straße 116

68305 Mannheim

Germany

1

0117

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.

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 Solution User Training Guide

Version 4.0 November 2015

For general laboratory use.

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Roche FLOW SW User manual

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