Biomerieux ScanRDI Manual - English

ScanRDI
161150-541 - A - en - 2014/07 161150-541
User Manual
bioMrieux SA
Chemin de lOrme
69280 Marcy-lEtoile - France
Tl: 33 (0)4 78 87 20 00
Fax: 33 (0)4 78 87 20 90
www.biomerieux.com
General Information
The content of this manual is based on the ScanRDI 2.
Please discard any previous copies of this manual if relevant.
This manual may contain information or references relating to certain bioMrieux products,
software or services which are not available in the country of release; this shall not mean that
bioMrieux intends to market such products, software or services in such country.
To request copies of publications or for any technical request / assistance, contact bioMrieux
or your local distributor (contact information available on www.biomerieux.com).
Note: The screens and figures shown are intended as illustrations only and must not be interpreted
as actual representations of data, results or equipment.
Screens and equipment are not shown to scale.
IMPORTANT: Please read this manual carefully before using ScanRDI.
Intellectual Property
BIOMERIEUX, the blue logo and ScanRDI, are used, pending and/or registered trademarks
belonging to bioMrieux, or one of its subsidiaries, or one of its companies.
Any other name or trademark is the property of its respective owner.
2014 bioMrieux SA
bioMrieux SA RCS Lyon 673 620 399.
Table of Contents
Introduction to the System ........................................................................................ 1-1
Intended Use and Users. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Benefits and Limitations of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
21 CFR 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Warning and Safety Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Statement Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
General Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Standard Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Safety Information ...................................................................................................... 2-1

System Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Instrument Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Left side of the ScanRDI analytical module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Back of the ScanRDI analytical module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Top of the ScanRDI analytical module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
System Description and Basic Operations .............................................................. 3-1

System Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
List of Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
List of Consumables and Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Technical Data and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Computer Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Overview of Operation Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
System Installation and Configuration ..................................................................... 4-1

System Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
System View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Connection to the ScanRDI system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Connections to PC computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Connecting the system to a LAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Use of antivirus software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Workflow and Instructional Procedures ................................................................... 5-1

Typical protocol steps (for information) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
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System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Analytical Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Status and Indicator Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Starting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Shutting Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Inserting a membrane into the ScanRDI analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Positioning a CB04 membrane tab on the CB04 membrane holder . . . . . . . . . . . . . . . 5-5
Positioning a FIFU device membrane on the FIFU membrane holder. . . . . . . . . . . . . . 5-5
Positioning the membrane holder on the sample drawer. . . . . . . . . . . . . . . . . . . . . . . . 5-5
ScanRDI software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Using the ScanRDI software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Interface presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Analysis Properties panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Scan panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Verification panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Starting the ScanRDI software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Exiting the ScanRDI software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
On the log on screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
In the Main panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
User access rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

My account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Logging on to my account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Locking my account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Changing my account password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Logging off my account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Managing sessions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Creating a session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
On the log on screen: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
In the Main panel: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Locking a session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Unlocking a session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Exporting a session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
To remove a session: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Importing a session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18

Loading a session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Consulting the session information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Editing the session information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Signing a session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Performing a daily control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Calibrating the Microscope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Checking the home position. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Setting the home position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
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Setting the calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22

Setting microscope focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23
Creating an analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23
Opening/Closing an analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Opening an analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Closing an analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Editing the analysis properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Performing an analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Aborting an analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Consulting analysis data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Sorting the session analysis data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Checking the analysis step status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Checking the analysis progress status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Checking the analysis result status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Checking the analysis error status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Consulting the verified analysis map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Checking the protocol used for the analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Verifying an analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Displaying the Events map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Zooming in/out on the Events map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Selecting an event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Verifying events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Commenting on an event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Saving a verified analysis map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Generating a session report as a .pdf file. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Exporting data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
Exporting a session as a .csv file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
Exporting an analysis as a .csv file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
Generating a view of the current active screen as a .pdf file . . . . . . . . . . . . . . . . . . . . 5-33
Managing advanced analysis features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Displaying plots of an event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Displaying 2D plots of an event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Displaying 3D plots of an event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Choosing the channels to display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Choosing the axis to display with 2D plots. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Displaying the plot grid lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Hiding the plot grid lines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Re-verifying an analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Consulting event discriminants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Generating a view of the current active screen as a .pdf file . . . . . . . . . . . . . . . . . . . . . . . 5-38
Generating a 2D plots view of an event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38
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Generating a 3D plots view of an event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38

Managing administration settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39
Managing security settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39
Managing user accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-40
Creating a user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-40
Editing a user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41

Activating a user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41
Deactivating a user account. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41
Locking a user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Removing a user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Managing session settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Setting the default session display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Displaying the data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Hiding the data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Setting a session display for my account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43

Displaying the data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Hiding the data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Setting the user account inactivity timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-44

Configuring a report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-44
Managing instrument settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45
Changing the interface language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45
Selecting the device to use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45
Managing daily control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46
Activating/Deactivating the end-of-session daily control . . . . . . . . . . . . . . . . . . . . . . . 5-46
Activating the end-of-session daily control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46
Deactivating the end-of-session daily control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46
Consulting daily control history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46

Managing the audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-47
Consulting the audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-47
Exporting the audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-47
Managing protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48
Creating a protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48
Editing a protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Duplicating a protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Deleting a protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Exporting a protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Importing a protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Managing applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Exporting an application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Importing an application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Consulting information about the ScanRDI software . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
161150-541 - A
iv
ScanRDI
Table of Contents
User Maintenance ....................................................................................................... 6-1

Cleaning Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Preparing the cleaning solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Cleaning the membrane holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Appendix - Configuring the barcode reader.............................................................A-1

Appendix - Troubleshooting ......................................................................................B-1
Error Messages and Recovery Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
Appendix - Glossary ...................................................................................................C-1
161150-541 - A
ScanRDI
Introduction to the System
Intended Use and Users

The ScanRDI system is used for the microbiological control of filterable samples in quality
control laboratories, production departments and services laboratories in the pharmaceutical
or cosmetic industry. Samples from in-process or end products and from direct or indirect
environmental sampling, can be used.
Benefits and Limitations of Use

The key objectives and benefits of the ScanRDI solution are listed below:
Analysis complete in less than 4 hours
Sensitivity down to one micro-organism in a sample
No cell multiplication required
Direct detection of bacteria, yeast, molds and spores
Linear response from 1 to 10,000 microbial cells
Non-destructive test protocol allows confirmation
Robust and easy-to-use
21 CFR 11
The system provides features that enable customers to be compliant with 21 CFR 11
requirements.
When the instrument is configured to operate in 21 CFR 11 mode, certain functions require
login (for example, viewing, editing, and printing test data).
Warning and Safety Messages

The user documentation uses several types of statements to alert you to important
information. Important information is labeled in text and identified using symbols.
Statement Types
The statement types are Warning, Caution, Important, and Note. The following examples
define each statement type. The general caution symbol is used in these examples, but other
symbols (see Standard Symbols on page 1-5) may be used instead.
The warning messages in this manual mainly refer to:
WARNING
A Warning statement alerts the user to the possibility of injury, death, or
other serious adverse reactions associated with the use or misuse of the
device.
161150-541 - A
1-1
ScanRDI
General Statements
CAUTION: A Caution statement alerts the user to the possibility of a problem with
the device associated with its use or misuse. Such problems include device
malfunction, device failure, damage to the device, or damage to other property.
Where applicable, a Caution statement may include a precaution that should be
taken to avoid the hazard.
IMPORTANT: An Important statement relates to content presented in the user documentation. It is
used to reinforce the users understanding of selected information.
Note: A Note statement supplies additional information about a topic.
General Statements
This section provides important statements that apply to all products. Equipment meets the
requirements and standards stated in the certificate supplied with it.
WARNING
Equipment is intended for professional use only.
Laboratory personnel should be qualified and adhere to the principles of
good laboratory practice.
All the user documents supplied must be read prior to use of the equipment.
Under no circumstance should the user dismantle equipment due to the risk
of touching dangerous parts, including parts that are infectious or
connected to a source of electric power.
Do not obstruct the equipment and hardware ventilation apertures, and
leave sufficient clearance around the equipment for the circulation of air.
All biological fluids should be considered as potentially infectious. Suitable
individual protective equipment is required when handling chemical or
biological substances.
bioMrieux is in no case liable for the harmful consequences of incorrect
use or improper handling of these substances.
161150-541 - A
1-2
ScanRDI
General Statements
WARNING
Electromagnetic Compatibility (EMC):
The EMC class of the equipment is indicated on the certificate supplied with
it.
If equipment is a class A product, it may cause radio interference in a
domestic environment, in which case the user will be required to correct the
interference at his own expense.
Do not use this device near strong sources of electromagnetic radiation (for
example, intentionally unprotected radio-electric sources), which could
interfere with the operation of the equipment.
It is recommended to evaluate the electromagnetic environment before
starting the device.
WARNING
In order to avoid computer viruses or abnormal functioning of your
equipment, never download any software other than those provided by
bioMrieux.
All computer media (CD, DVD, USB key) supplied with this equipment
should be stored and stocked in a suitable location.
Only modify the software configuration parameters you are authorized to
modify and which are described in the user documentation.
WARNING
In an effort to reduce the risk of spreading a virus to bioMrieux equipment,
it is recommended that only bioMrieux supplied USB devices are used with
bioMrieux equipment. The use of personal USB devices is not
recommended. To avoid computer viruses and the potential loss of
functionality and/or results, use caution when transferring USB devices
between computers. Do not use USB devices intended for bioMrieux
equipment in other computers that do not have current antivirus software
installed and active.
161150-541 - A
1-3
ScanRDI
General Statements
WARNING
Decontamination of equipment at the end of its life cycle:
The following instructions must be followed by all users in countries where
local legislation imposes the treatment and recycling of equipment at the
end of its life cycle.
As a general rule, and as a precautionary measure, any part of the
equipment (including sub-assemblies, components and materials)
considered to be potentially infectious, must be decontaminated, whenever
possible, or removed if decontamination is impossible or presents a risk.
Any part considered to be potentially infectious, which is not
decontaminated, must be removed from the instrument before following the
normal channels for elimination of infectious products, in accordance with
local regulations.
The decontamination instructions in the user documentation correspond to
the parts of the equipment that are potentially infectious according to their
intended use. These operations must be performed before the equipment is
transferred to a third party.
However, bioMrieux cannot exclude that other parts of the equipment have
not been contaminated in other circumstances, in particular as the result of
spillage of infectious substances. In this case, the user is solely responsible
for decontaminating these parts or removing them before they follow the
normal channels for elimination of infectious products.
WARNING
This statement only applies to European countries with regard to the waste
electrical and electronic equipment European directive:
You can play an important role in contributing to reuse, recycling, and other
forms of recovery of waste electrical and electronic equipment. Sorting this
type of waste significantly reduces potential negative effects on the
environment and human health as a result of the presence of hazardous
substances in electrical and electronic equipment.
At the end of the life cycle of this product, do not dispose of the product as
unsorted municipal waste, even if it is decontaminated. It is imperative that
you contact bioMrieux to assure its appropriate disposal.
IMPORTANT: Electrical or other connections should only be made using the accessories supplied
with the equipment.
IMPORTANT: It is important to follow all the restrictions on use, particularly concerning temperature,
storage, installation and voltage, which are indicated on the product label or in the user
documentation.
161150-541 - A
1-4
ScanRDI
Standard Symbols
IMPORTANT: The accuracy of results obtained with this equipment depends on the maintenance
operations described in the user documentation (user maintenance and/or periodic
preventive maintenance performed by bioMrieux).
IMPORTANT: The user should be aware that if the maintenance operations are not performed, are
only partially performed, or are not performed as described in the user documentation,
bioMrieux is in no case liable for any false test results obtained.
IMPORTANT: It is recommended to keep the original packaging materials in case the equipment
needs to be moved. Any damage directly or indirectly resulting from the transport of
the equipment without adequate containers will not be covered by the warranty.
Standard Symbols
The following symbols may appear in the instructions for use or on the instrument, package
inserts, or packaging. Some of the following symbols may not be used on the instrument,
package insert nor packaging. When surrounded by a triangle on a yellow background, the
symbol highlights an immediate warning and is positioned on the instrument itself.
CE-Marking of Conformity
Catalog number
Batch code
Serial number
Consult Instructions for Use
Use by date
Manufacturer
Date of manufacture
This way up
Do not stack
Caution, consult accompanying documents
Contains sufficient for <n> tests
Do not reuse
161150-541 - A
1-5
ScanRDI
Standard Symbols
Keep dry
Keep away from sunlight
Fragile, handle with care
Protect from light
Humidity limitation
Keep away from magnetic field
Temperature limitations
Upper limit of temperature
Lower limit of temperature
Sterile
Positive control
Negative control
Biological risk
Electric shock warning
Radiation warning
Potential pinch-point warning
Laser beam
Shearing hazard
High temperature
Hazardous magnetic field
161150-541 - A
1-6
ScanRDI
Standard Symbols
Potential tip-over/crush hazard
Acute toxicity
Corrosives
Sodium azide
Irritant
Recyclable
Separate collection for waste electrical and

electronic equipment
Environmentally friendly use period. Actual

number of years may vary by product. This
symbol is typically orange in color.
Fuse
Direct current
Alternating current
Both direct and alternating current
Three-phase alternating current
Earth (ground) terminal
Protective conductor terminal
Frame or chassis terminal
Equipotentiality
ON (supply)
OFF (supply)
ON (only for a component of the system

equipment)
OFF (only for a component of the system

equipment)
Equipment protected throughout by

double insulation or reinforced insulation
(Equivalent to Class II of IEC 536)
Ethernet port
161150-541 - A
1-7
ScanRDI
Safety Information
It is essential that the warnings, cautions and safety requirements contained in this manual are
read and understood by the user before operating the system.
Warning symbols have been placed on the system to draw your attention to areas of potential
hazards.
System Compliance
The ScanRDI system conforms to the relevant European regulations for electrical safety and
electromagnetic compatibility (EMC).
bioMrieux recommends the evaluation of the electromagnetic environment before operating

the instrument.
CAUTION: Use of this instrument in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets, etc.) may cause damaging static
discharges that may cause erroneous results.
161150-541 - A
2-1
ScanRDI
Instrument Labels
Safety Information
Instrument Labels
Left side of the ScanRDI analytical module
This label indicates that there

is class 3B Laser radiation
when the cover is open and
interlocks are defeated.
Avoid exposure to beam.
Read the instructions before
use.
This label indicates that for

continued protection against
fire and shock you need to
replace the fuse with an
identically rated fuse.
This label indicates that the

cover is closed, the laser is a
Class 1 laser product
complying with 21CFR
1040.10, 1040.11 and with IEC
60825-1, Edition 2 (2007).
161150-541 - A
2-2
ScanRDI
Instrument Labels
Safety Information
Back of the ScanRDI analytical module
Caution - Class 3B Laser

radiation when open and
interlocks defeated.
Avoid exposure to beam
Danger
Disconnect the mains supply
before removing this cover
Manufactured in the U.K.

Model
Serial No.
Manuf. date
161150-541 - A
2-3
ScanRDI
Safety Precautions
Safety Information
Top of the ScanRDI analytical module
Caution - Class 3B Laser

radiation when open and
interlocks defeated.
Avoid exposure to beam
Danger
Disconnect the mains supply
before removing this cover
Safety Precautions
Pay particular attention to the following safety precautions. If these safety precautions are
ignored, injury or damage to the instrument may occur. Each individual precaution is
important.
WARNING
If the equipment is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired.
161150-541 - A
2-4
ScanRDI
Safety Precautions
Safety Information
WARNING
Do not replace detachable main supply cords by inadequately rated cords.
Only use main supply cords provided by the manufacturer.
Do not replace electric cables. If cables do not have the same technical
specificities, there is a risk of electrical shock.
WARNING
Electronic equipment can be the source of electrical shocks. Installation,
service, and repair should only be performed by authorized and qualified
bioMrieux personnel.
WARNING
All power switches should be off when connecting or disconnecting cables
to power outlets to reduce the risk of electrical shock.
WARNING
bioMrieux recommends connecting this instrument to a main power outlet
that is protected with a ground fault circuit interrupter to reduce the risk of
electrical shock.
CAUTION: Any liquid spilled on the system may result in system malfunctioning. If
liquid is spilled on the system, wipe it up immediately using decontamination
wipes.
CAUTION: The computer and its operating system have been carefully configured
for optimal system performance. Altering the configuration may severely hamper
the usability of the instrument.
161150-541 - A
2-5
ScanRDI
Safety Precautions
Safety Information
Note: Before performing electrical safety or other compliance testing on the instrument, contact your
local bioMrieux representative.
WARNING
The user must only perform the maintenance operations described in this
user manual and rigorously follow each of the steps.
The use of tools not specified by bioMrieux is forbidden.
Powder-less gloves, a lab coat and protective glasses or goggles must be
worn when performing maintenance operations.
Always use personal protective equipment, including gloves, a lab coat and
safety glasses or goggles when handling reagents.
161150-541 - A
2-6
ScanRDI
System Description and Basic Operations
System Description
The ScanRDI system is a machine that is capable of the rapid detection and enumeration of very
low numbers of micro-organisms. Samples are collected on a solid support, labelled with a
fluorescent marker and laser scanned.
Liquid samples are taken and filtered using a 25 mm diameter membrane which retains microbial
cells on its surface. The retained cells are directly labelled in situ with viability markers in order to
obtain a total viable count reading.
The membrane is then manually transferred to the analyzer which laser scans the entire surface of
the membrane and analyzes the resulting data. The laser scanning facility is fully overlapping to
ensure that any cell fluorescence on the membrane will be detected by the ScanRDIs system
multiple detection channels.
To ensure reliable results, the ScanRDI system incorporates advanced proprietary discrimination
parameters. Thus, the ScanRDI system can differentiate between valid signal (labeled microorganisms) and background noise (electronic, optical, and auto-fluorescence from particles). The
resulting data is then transferred to a computer memory.
The data is available as a scan map which shows the location of each detected micro-organism.
With the aid of a link to a motor-driven microscope stage, each micro-organism that has been
detected can be visually confirmed on the membrane if necessary under the microscope.
The ScanRDI system comprises the following main items:
Analytical module
Computer and peripherals (display, keyboard, mouse, printer)
Microscope with motorized microscope stage, Keypad and Joystick. (optional)
List of Accessories
Designation
Quantity
Spare Fuse - 3.15 AT
Spare Fuse - 6.3 AT
Reference membrane (graticule on holder)
Set of 4 instrument keys (2 x power + 2 x interlock override switch)
Membrane holder (holder + CB04 adapter)
BLUE BOX
List of Consumables and Reagents

The ScanRDI system is designed to be used with specific reagents and consumables that
can be obtained from bioMrieux.
Note: For details about the reagents and consumables, please refer to the bioMrieux reagents and
consumables with defined protocols.
Note: Only trained personnel should use the ScanRDI system, disposable, reagents and
consumables.
161150-541 - A
3-1
ScanRDI
Technical Data and Specifications

Dimensions
Analytical module
Depth: 55.7 cm
Height: 44 cm
Width: 80.1 cm
Weight: 48kg
Computer
Depth: 45 cm
Width: 17 cm
Height: 45 cm
Weight: 16 kg
Monitor (typical)
Width: 45 cm
Depth: 18 cm
Height: 32cm (compressed) - 44 cm (extended)
Weight: 5 kg
Keyboard
Depth: 15 / 22 cm
Width: 45 cm
Height: 3 cm
Keypad + joystick
(optional)
Keypad: 15x12.5x3.5 cm
Joystick: 11.5x9x7 cm
Wire length to analyzer: 290 cm
Wire length from Keypad to Joystick: 70 cm
Weight
Analytical module
Weight: 48kg
Computer
Weight: 16 kg
Monitor (typical)
Weight: 5 kg
Keypad + joystick
(optional)
Total Weight: 1kg
Electrical Specifications
The ScanRDI system operates on a single-phase grounded power line at 110V / 230V at
50Hz / 60Hz. Voltage variations of +/- 10% can be tolerated
161150-541 - A
Fuse
T6.3A - H 500V for 110V operation

T3.15A - H 500V for 230V operation
Analytical module
110V / 230 V (10%) at 50/60Hz 6.3A / 3.15A
Computer
115V / 230V (10%) at 50/60 Hz, 6A / 3A
Monitor (typical)
100 240V at 50/60Hz, 1.5A
3-2
ScanRDI
Environmental Conditions
Ventilation sufficient to lower the room temperature to below 30C; maximum 80% relative
humidity, assuming the total system load is 14A at 110V (8A at 230V).
Temperature: 15 to 30C
Humidity: 5 to 80% non-condensing
Altitude: 0-2,000 meters
Sound Level: Noise emission level: < 85db(A)
Computer Specifications
Computer Process &

Software
Data processing by Intel Pentium Pro PC minimum

Mass Storage: 100 GB or higher hard disk
Data storage: at least 10,000 scans with full sample details
Operating system: Microsoft Windows 7 Pro Edition (English)
Monitor
Screen size: 19 inch diagonal or larger

LCD color SVGA resolution
Printer
The ScanRDI system supports a USB printer
Overview of Operation Components

The ScanRDI analytical
module scans the
membrane and detects all
objects of interest, as well
as their position on the
membrane.
Analytical module
The ScanRDI computer

enables you to use the
ScanRDI software to
manage the Scan and
Verification steps.
Computer
161150-541 - A
3-3
ScanRDI
The microscope, keypad

and joystick enable you to
manage the Verification
steps to confirm that
objects of interest are
micro-organisms.
Microscope +
Keypad + joystick
(optional)
161150-541 - A
3-4
ScanRDI
System Installation and Configuration

Installation of the ScanRDI system is performed by a bioMrieux engineer.
System Installation
System View
Monitor
Keyboard
Printer
Mouse
Computer
USB Cable
Analytical
Module
Microscope
161150-541 - A
Joystick
4-1
Keypad
ScanRDI
System Installation
Main power supply
Printer Cable
Mouse cable
Joystick Cable
Keyboard Cable
Microscope Cable
Monitor Cable
Keypad Cable
Connection to the ScanRDI system
Fuse FS
Key Switch
T6.3AT for 110V operation

T3.15AT for 220-240V operation
Main power
switch with
fuse FS
USB Cable
to PC
Computer
Main power
supply
Joystick Cable
161150-541 - A
4-2
ScanRDI
Connections to PC computer
Connections to PC computer
Main power
supply
USB port to Analyzer

(Always use the same
port to connect the
analyzer)
Mouse Cable
Monitor Cable
Keyboard Cable
Printer Cable
Some PCs have a different back panel layout from the one shown above.
For additional information on your system PC, please refer to the PC user manual.
Connecting the system to a LAN

The System PC is dedicated to the management of the System i.e. real time data acquisition
and processing as well as controlling the various electronic and electromechanical devices
within the instrument (scanners, PMTs, laser, drawer, microscope stageetc.).
During a scan, the System PC acquires and processes up to 12 Mbytes of data per second in
real time.
There is no time left to handle external asynchronous requests like those coming from the
network.
161150-541 - A
4-3
ScanRDI
Use of antivirus software
Due to the real time application constraints, the System PC cannot handle properly such
requests.
The connection of the System PC to a Local Area Network is therefore still possible within the
following constraints:
1. Do not configure protocols other than the one used by the LAN.
2. Do not share any System PC folder or disk drive with the network.
3. Do not share the local System printer.
4. Do not connect the System PC to a network printer
5. Do not connect the System PC to a network disk drive (particularly to dynamically store
the data files)
6. Do not install any client software (the System is not designed to be operated from a
remote location).
7. If the TCP/IP protocol is installed, do not use the System PC to establish connections with
Internet when the System application software is running.
8. The System PC should not work as a slave to the network (i.e. being subjected to random
access requests from the network).
9. When the System PC data files need to be archived or exported, they can be sent to a
remote location on the network but only when the System application software is in the
idle state (instrument not scanning and not doing a microscopic verification).
Use of antivirus software

Where the local policy requires that anti-virus software be installed on all PCs within an
organization, scanning of the files should only be initiated when the System application
software is not running (automatic scanning at preset time(s) is therefore not possible).
161150-541 - A
4-4
ScanRDI
Workflow and Instructional Procedures
Typical protocol steps (for information)

Protocol
details,
reagents
and
consumables are provided separately
from the ScanRDI system by
bioMrieux Application Specialists.
Filtration
consists of collecting and retaining
on a membrane all the microorganisms present in the sample.
Labeling
consists of staining all the microorganisms with a fluorescent dye in
order to enable their detection.
Scan
the instrument performs a laser scan to
detect and discriminate objects of interest
found in the sample in order to identify
potential micro-organisms.
Verification
consists of confirming that the events are
micro-organisms. The user manages the
microscope stage via the application, in order
to observe the events and confirm whether
they are micro-organisms.
161150-541 - A
5-1
ScanRDI
System Overview
System Overview
Analytical Module
Drawer access
Status and
Indicator lights
161150-541 - A
Sample
drawer button
5-2
ScanRDI
System Overview
Status and Indicator Lights

Power
The Power indicator indicates the ScanRDI power status.
On
ScanRDI analytical module is on
Off
ScanRDI analytical module is off
Laser
The Laser indicator indicates the ScanRDI laser status.
On
Laser is on
Off
Laser is off
Sample
The Sample indicator indicates the ScanRDI membrane holder status.
On
The membrane holder is correctly positioned in the scanning

position and the drawer is closed. Scan can be initiated.
Off
The membrane holder is missing or is in the wrong position.

Scan impossible
Sample Drawer button

The indicator of the Sample Drawer button indicates the ScanRDI scan
status.
The scan is initiated. It will flash for the duration of the scan.
Flashing
161150-541 - A
Note:When the Sample Drawer button is flashing, the

button must not be operated or the scan operation will
failed.
On
The scan is complete.
Off
Opening the drawer to access the membrane will reset the

indicator to the OFF state.
5-3
ScanRDI
Starting the System
Starting the System

WARNING
The power cord serves as the primary disconnect device for the ScanRDI
system. Be sure to plug the power cord into a grounded power outlet that is near
the ScanRDI system and readily accessible.
WARNING
The protective earth conductor must be connected for safety reasons. Check that
the power cable has the proper earth wire, and it is properly connected. It is unsafe
to operate the ScanRDI system without the protective earth conductor terminal
connected.
1. Switch the power switch to the ON position.

2. Turn the Key switch clockwise
a quarter turn.
3. Switch on the microscope, if
present.
Power
switch
Key
Switch
4. Switch on the printer.

5. Switch on the PC and allow
Microsoft Windows 7 to start.
6. Log on to Windows with a
valid user name and
password (please contact
your Computer Administrator).
Note: Windows administrator account is restricted to bioMrieux support technicians or local
computer administrator.
7. Double-click on
to start the ScanRDI software.
The system will be ready for scanning after 10 minutes of laser warming up.
Shutting Down the System

Note: The ScanRDI system should only be powered down by following the procedure described
below. Failure to do this could cause damage to the ScanRDI system.
1. Turn the key switch anticlockwise a quarter turn to deactivate the power supply.
The cooling fans stay on.
2. On the computer, exit the ScanRDI software.
3. Shut down the computer, microscope (if present) and printer.
4. Turn off the power switch on the ScanRDI analytical module.
161150-541 - A
5-4
ScanRDI
Inserting a membrane into the ScanRDI analyzer
Inserting a membrane into the ScanRDI analyzer

Positioning a CB04 membrane tab on the CB04 membrane holder
1. Perform the filtration and labeling steps.
2. Position the support pad.
3. Position the CB04 membrane tab in the notch
of the CB04 membrane holder.
Positioning a FIFU device membrane on the FIFU membrane holder

1. Perform the filtration and labeling steps.
2. Position the support pad.
3. Position the FIFU membrane in the frame
positioning pin on the membrane holder.
Positioning the membrane holder on the sample drawer

4. Position the membrane on the membrane
holder.
5. Push the sample drawer button to open the
sample drawer.
6. Place the membrane holder positioning
notch on the membrane holder positioning
pin.
7. Push the sample drawer button to close the
sample drawer.
161150-541 - A
5-5
Bottom view of the

membrane holder
ScanRDI
ScanRDI software
ScanRDI software
The ScanRDI software enables you to manage the Scan and Verification steps.
In order to complete these steps, there are some intermediate steps to perform, such as
creating a session, performing a daily control, signing a session, etc. (see Using the
ScanRDI software on page 5-7.
161150-541 - A
5-6
ScanRDI
ScanRDI software
Using the ScanRDI software

Log
on
Create or open a session

to gather and manage a set of
analyses
Perform a control
of the instrument to verify its
fluorescence detection
capability
Check microscope calibration &

Set microscope focus
to ensure that the microscope is ready for operation
Create an analysis
to define the
analysis properties
Perform an analysis
ScanRDI scans and detects

objects of interest in the sample
Verify an analysis
to confirm if
the sample contains
micro-organisms
Sign a session
to append your
electronic signature
Log
off
161150-541 - A
Generate a session report

for traceability
5-7
ScanRDI
ScanRDI software
Interface presentation
Session panel
Shows the main information of the

analyses of the session
Analysis ID panel
Shows the list of the analysis of the

current session, their step and
result status.
Enables the access to the analysis
operations.
Toolbars
Routine & Expert
users toolbar
Enables the access to the

functionality menus.
Administrator
users toolbar
4
Session Manager
panel
Enables the access to the session

functions.
System Status panel
Shows the status of the system,

and enables to manage the Daily
Controls.
Account Manager
menu
Enables to manage the logged

account and to consult the Audit
Trail.
Date & Time
161150-541 - A
5-8
ScanRDI
ScanRDI software
Analysis Properties panel
Properties tab
Shows the Analysis

Properties panel
Scan tab
Shows the Scan panel
Validation tab
Shows the Verification

panel
Scanpanel
161150-541 - A
Properties tab
Shows the Analysis Properties

panel
Scan tab
Validation tab
Shows the Verification panel
Events map
Next event arrows
Represents events scanned with

their position on the membrane
Enables the selection of an event
on the Events map
5-9
ScanRDI
ScanRDI software
Verificationpanel
Properties tab
Shows the Analysis Properties

panel
Scan tab
Validation tab
Shows the Verification panel
Events map
Represents events scanned with

their position on the membrane
Event Verification tags
Enables to tag the events as

microorganism, particle, or unknown
161150-541 - A
Statistics Section
5-10
Shows the amount of events in each

category once you have tagged them
ScanRDI
Starting the ScanRDI software
Starting the ScanRDI software

The ScanRDI software must be installed correctly.
A Windows session must be opened.
1. Double-click
The ScanRDI software log on screen appears.
Exiting the ScanRDI software

IMPORTANT: Make sure that you have no steps in progress before exiting the ScanRDI software.
On the log on screen

Note: If your account is locked, you must enter your user credentials before clicking Exit.
1. Click Exit.
2. Click
The ScanRDI software is now closed.

OR
In the Main panel

1. In the Account Manager menu, select Exit.
The Exit application window appears.
2. Click
The ScanRDI software is now closed.
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5-11
ScanRDI
User access rights
User access rights

Some functions are only available for user with specific access rights. 3 types of user access
are available:
Routine User is dedicated to users who operate the system routinely.
Expert User is dedicated to routine users with a deeper comprehension of the technology,
capable of interpreting event's line amplitudes, and capable of managing protocols.
Administrator user is dedicated to the management of users account and software interface
preferences.
Note: A specific type of user dedicated to system servicing (called "Service") exists and is
restricted to authorized and qualified bioMrieux personnel only. Access to such

privileges user account by a customer is forbidden.
Functions with restricted access
Managing
sessions
Managing
analyses
Managing
advanced
analysis
features
161150-541 - A
Exporting a
Control
session
Loading a
Control
session
Creating an analysis
Routine
User
Displaying 2D or 3D
plots of an event
Choosing the
channels to display
Choosing the axis to
display with 2D plots
Displaying/Hiding the
plot grid lines
Re-verifying an analysis
Consulting event discriminants
Generating a Generating a 2D plots
view of an event
view of the
current active Generating a 3D plots
screen as a
view of an event
.pdf file
Displaying
plots of an
event
5-12
Expert
User
Administrator
User
X
X
X
X
X
X
X
X
X
ScanRDI
User access rights
Functions with restricted access
Managing
administration
settings
Expert
User
Administrator
User
Managing security settings

Managing
Creating a user
user accounts account
Editing a user account
Activating/
Deactivating a user
account
Locking a user
account
Removing a user
account
Managing
Setting the default
session
session display
settings
Setting a session
display for my account
Setting the user
account inactivity
timer
Configuring a report
Changing the interface
Managing
language
instrument
settings
X
X
Managing
daily control
settings
Managing
protocols
161150-541 - A
Routine
User
X
X
X
X
X
X
X
X
X
Activating/
Deactivating the endof-session daily
control
Consulting daily
control history
Creating a protocol
Editing a protocol
Duplicating a protocol
Deleting a protocol
Exporting a protocol
Importing a protocol
5-13
ScanRDI
My account
My account
Logging on to my account
IMPORTANT: It is requested to change your password when you log on to your account for the first
time.
The log on screen must be displayed.
1. Click on the Session drop-down list, and select one of the following:
Create new session
Load existing session
Load last session
2. Enter your User ID and password.
3. Click Log on.
The Main panel appears.
Locking my account
1. In the Account Manager menu, select Lock.
The log on screen appears.
Your user ID appears in the User ID field indicating that your account is locked. Only user
with Administrator or Service user access rights can unlock the software access.
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5-14
ScanRDI
Managing sessions
Changing my account password

IMPORTANT: You can change your password if necessary. You may also be prompted to change
your account password for the following reasons:
This is the first time you log on to your account with a default password.
Your account is about to expire.
The administrator has edited your account status and/or password.
Your password is case sensitive
1. In the Account Manager menu, select Change password.
The Change password window appears.
2. Enter your new password.
3. Re-enter your new password to confirm it.
You can select the Show password check box to make sure it does not include any
errors.
4. Click
Your new password is set.
Logging off my account

1. In the Account Manager menu, select Log off.
The Log on screen appears.
Managing sessions
Creating a session
Note: A session gathers a set of analyses. Once you have performed and verified the
sessions set of analyses, you can sign the session and generate a report for
traceability.
IMPORTANT: When you create a new session, the protocol that you select becomes the default
protocol used for that sessions set of analyses. If necessary, you can select another
protocol in the analysis properties later on.
On the log on screen:

1. Click on the Session drop-down list and select Create new session.
2. Enter your user credentials and click Log on.
The Create new session window appears.
OR
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5-15
ScanRDI
Managing sessions
In the Main panel:

1. Go to the Session Manager panel and select New session.
The Create new session window appears.
2. Enter the session information.
The User ID and the Session ID are
generated automatically.
You can only edit the Session ID when
you first create the session.
Note: The default session ID corresponds to the date
(yymmdd) followed by the session index number.
In the Comments field, enter a comment describing the session.
3. Enter the protocol information.
Click on the drop-down list to select a protocol.
You may also click
information.
4. Click
to consult the protocol and reagents/consumables
to save the new session.
The new session is loaded in the Session panel.
Locking a session
Note: Locking a session makes it read-only. You can only consult the analysis information.
1. Click
in the Session Manager panel.
The padlock is now closed (
) indicating that the session is locked.
Unlocking a session
IMPORTANT: You cannot unlock a session if it has been signed (
1. Click
).
in the Session Manager panel.
The User Credentials window appears.

2. Enter your user credentials and click
The padlock is now open (
161150-541 - A
), indicating that the session is unlocked.
5-16
ScanRDI
Managing sessions
Exporting a session
Note: You can export sessions in order to manage session data outside of the ScanRDI software.
You can also export sessions and store the data on your PC, in order to remove the sessions
from the application. Regular export of sessions for archiving included Control sessions - is
recommended to ensure the space disk availability.
The following rules apply to the archiving and importing of sessions:
New sessions and scans are saved in the Live folder.
Data from the Live and Imported folders are digitally signed when archived to prevent
tampering.
Data that have been digitally signed and verified are imported in the Imported folder.
Data without a digital signature or data with a digital signature that cannot be verified are
imported in the Untrusted folder.
IMPORTANT: The current session cannot be exported. You must load another session if the current
session is the one you want to export. You must have the required access rights to
export sessions of daily controls. See User access rights on page 5-12
1. Click
In the Archive menu, select Export session.

2. The Export session(s) window appears.
3. Click one of the following:
To export a live session.
Live
To export a session that has already been imported (see
Importing a session on page 5-18).
Imported
To export an imported session that is corrupted.

Untrusted
To export a session containing all the daily controls performed.
Control
The sessions of the type selected are displayed.
4. Select the required session.
5. In the Destination field, select the destination folder and click Choose.
6. Click
The session is exported to the selected destination folder.

7. Click
161150-541 - A
to close the Export session(s) window.
5-17
ScanRDI
Managing sessions
To remove a session:
8. Click
9. In the Archive menu, select Export session.

The Export session(s) window appears.
10. Double-click on the type of session required and select the session you want to remove.
11. In the Exported session information section, select the Remove exported session
check box.
12. Click
The session is removed.
Importing a session
1. Click
2. In the Archive menu, select Import session.

The Import session(s) window appears.
3. In the Exported session field, select the exported sessions to import.
The exported sessions selected are displayed.
5. Click
The session is imported to the Imported folder (see Loading a session on page 5-18), or
to the Untrusted folder if the imported session authenticity cannot be verified.
6. Click
to close the Import session(s) window.
IMPORTANT: Make sure that no session with the same session ID is already present. In such case, an
error will occur and the import operation will not be completed
Loading a session
IMPORTANT: You must have the required access rights to load sessions of daily controls. See User
access rights on page 5-12.
1. In the Session Manager panel, select Load Session.
The Load session window appears.
161150-541 - A
5-18
ScanRDI
Managing sessions
2. Click on one of the following:

To load a live session.
Live
To load a session that has already been imported (see
Importing a session on page 5-18).
Imported
To load an imported session that is corrupted.

Untrusted
To load a session containing all performed daily controls.
Control
The sessions of the type selected are displayed.
4. Click
The session is loaded in the Session panel.

The session is locked.
Consulting the session information

5. In the Session Manager panel, select Session Information.
The Session Information window appears displaying the session information.
Editing the session information

IMPORTANT: The User ID and Session ID cannot be edited.
6. In the Session Manager panel, select Session Information.
The Session information window appears.
7. Click
The information editing option is enabled.

8. Edit the required session information.
9. Click
161150-541 - A
to save changes.
5-19
ScanRDI
Managing sessions
Signing a session
Note: Signing a session means appending an electronic signature to the session and freezing the
data for further exploitation. The electronic signature appears on the session report when you
generate it for traceability (see Generating a session report as a .pdf file on page 5-32). When
you sign a session, it also means your work with this session is complete and the results are
no longer modifiable.
IMPORTANT: Once the session has been signed (
session.
), it cannot be edited. You cannot sign an empty
Depending on the daily control policy settings, you may or may not have to perform a daily
control before signing a session (see Activating/Deactivating the end-of-session daily
control on page 5-46).
1. In the Session Manager panel, select Sign session.
The Sign session window appears.
2. Enter your user credentials and click
The padlock is now replaced by the following icon (

been signed.
161150-541 - A
5-20
) indicating that the session has
ScanRDI
Performing a daily control
Performing a daily control

Note: A daily control of the instrument enables you to verify its fluorescence detection capability. The
ScanRDI software measures the mean intensity of a membrane with standard fluorescent
beads. If the measured mean intensity of the fluorescent beads is out-of-range then the daily
control status is failed, and the use of the instrument to perform an analysis is not allowed.
You must perform a daily control at start up before the first analysis, and when you sign a
session if required (see Signing a session on page 5-20).
IMPORTANT: Refer to the Daily Control document for protocol, reagent and consumable details
provided by bioMrieux Application Specialists.
1. Make sure that the loaded session is unlocked.
2. Make sure that the system status is Ready (in the System Status panel).
3. In the System Status panel, click
The Daily control window appears.

4. Insert the membrane containing the fluorescent beads and click
5. If required, select protocol.

6. Enter the traceability information in the table and click
The Daily control window appears when the daily control is complete:
The daily control status is OK.
The instrument is operational.
The daily control status is Failed.
The instrument is not operational.
Note:Refer to Daily Control document provided by
bioMrieux Application Specialists for required actions.
The daily control status is Warning. The instrument is
operational but you need to monitor the following daily control
results.
The daily control status is not performed.
The instrument is not operational.
161150-541 - A
5-21
ScanRDI
Calibrating the Microscope
Calibrating the Microscope

Checking the home position
The Microscope menu is enabled in the ScanRDI software.
1. Click
2. In the Instrument menu, select Microscope.

3. Click Check home to check the microscope home position.
The microscope is properly set up when the green mark is aligned with the reticule
present in the ocular.
The microscope is not set up when the green mark is not aligned with the reticule.
Perform calibration of the microscope. See Setting the calibration on page 5-22.
Setting the home position

1. Click

3. Click Set home to set the microscope home position.
4. Follow the instructions as they appear.
Note:
Stage Marker
Microscope
Stage
Setting the calibration

The reference membrane analysis must be opened.
1. Click

3. Click Microscope Calibration to check the microscope home position.
4. Follow the instructions as they appear.
5. Use the joystick to align the center of the cross with the center of the relevant spot
beneath the microscope and click OK.
161150-541 - A
5-22
ScanRDI
Setting microscope focus

A Map view must be opened.
1. Click directly an event on the Events map displayed.
2. Adjust the microscope focus to ensure that you have a clear observation of the objects
present beneath the microscope.
Note:
Refer to microscope user manual.

3. If necessary, repeat or click
to stop.
IMPORTANT: All fields must be filled in for the analysis properties to be valid. The sample ID and the
protocol must be completed before executing the analysis
2. In the Analysis panel, click
The Create new analysis window appears.

3. Enter the analysis information.
The analysis ID is automatically generated.
Note: The analysis ID corresponds to the session ID
followed by the analysis index number.
In the Comments field, enter a comment
describing the analysis.
4. Enter the sample information.
Enter the name of the sample in the Sample
ID field.
Or Scan the sample barcode with your barcode
reader.
Click on the drop-down list to select a description of the sample.
Or Enter a new description of the sample in the Description field and click
If necessary, select the sample description and click
to save it.
to delete it.
Edit the Filtrated volume used to filter the sample, if necessary.

The Filtrated volume value in the field corresponds to the filtrated volume defined in the
default protocol of the session.
161150-541 - A
5-23
ScanRDI
Opening/Closing an analysis
5. Enter the protocol information.

Click on the drop-down list to select a protocol.
You may also click
information.
to consult the protocol and the reagents/consumables
6. Enter the traceability information in the table.

You can fill in the Batch ID and Expiry date fields by:
Manually entering the information, or
Entering the information with a barcode reader
Clicking
to automatically retrieve the traceability information of the last batch used
with this protocol.
The traceability information is loaded.
7. Click
to save the new analysis.
The analysis appears in the Session panel.
Opening/Closing an analysis
At least one analysis must be created in the loaded session.
Opening an analysis
1. Click on the required analysis ID, or
on the icon in the Analysis ID
column.
Depending on the analysis progress
status (see Checking the analysis
progress status on page 5-27), the
following are displayed:
The Analysis properties panel
The Scan panel
The Verification panel
Closing an analysis
1. Click on the required analysis ID, or
on the icon in the Analysis ID panel.
The analysis list appears in the
Session panel.
161150-541 - A
5-24
ScanRDI
Editing the analysis properties
Editing the analysis properties

IMPORTANT: Once the analysis has been performed, the analysis ID and the protocol cannot be
edited.
2. In the Session panel, click on the analysis you want to edit.
3. Click on the Properties
tab.
The Analysis properties panel appears.

4. Click

5. Edit the required analysis information.
The analysis ID cannot be edited.
6. Click
to save changes.
Performing an analysis
Note: When you perform an analysis, you launch the ScanRDI system to laser scan and detect any
objects of interest in the sample.
The detected objects of interest, called events, are then represented on the events map, with
their position on the membrane.
The session must be unlocked.
The daily control must have been performed, and the status is OK or Warning.
1. Insert the membrane holder containing the sample to be analyzed.
2. Click on the Scan
tab.
Depending on the installation settings, the User Credentials window may or may not
appear.
3. If required, enter your user credentials and click
The progress bar indicates that the analysis has been launched and is in progress.
4. Once the analysis has been performed, check its status:
Analysis
successful
The Events map is displayed and the following icon

displayed in the Scan tab.
The step status of the analysis is
analysis step status on page 5-26.)
Analysis failed
(See Checking the
You aborted the analysis or an error occurred. The Events

map is not displayed and the following icon
in the Scan tab.
analysis step status on page 5-26.)
161150-541 - A
is
5-25
is displayed
. (See Checking the

ScanRDI
Aborting an analysis
Aborting an analysis
An analysis must be in progress.
1. In the System Status panel, click
2. Click
to abort the analysis.
The Events map is not displayed and the following icon

tab.
page 5-26)
is displayed in the Scan
. (See Checking the analysis step status on
Consulting analysis data

Sorting the session analysis data
You must have at least two analyses in the session.
Note: You can sort data in ascending or descending order.
1. Load the required session.
The set of analyses is displayed in the Session panel.
2. Click on the required column header to sort it either in ascending or descending order.
Checking the analysis step status

Note: In the Analysis ID panel, you can see at a glance the step status of an analysis. There are
three steps to perform an analysis:
the Properties definition,
the Scan,
and the Verification.
161150-541 - A
5-26
ScanRDI
2. Check the icon in the Analysis ID panel for the required analysis:
The analysis has been created.
The Properties definition step is either:
in progress (
),
or
complete.
IMPORTANT: You can still perform the Scan step even

if:
Some information is missing in the Properties definition (only the
analysis ID, the sample ID and the protocol must be filled in
before executing the analysis).
The reagents and consumables have expired. In this case the
analysis result is affected.
In these two cases, the following icon (

) is displayed in
the Properties tab.
To display the Properties tab you need to open the analysis
(see Opening/Closing an analysis on page 5-24).
The Properties definition and Scan steps are complete.
The Properties definition, Scan and Verification steps are

complete.
One of the three steps has not been completed correctly.

Open the analysis to check its progress status (see Checking
the analysis progress status on page 5-27).
Checking the analysis progress status

Note: When you open an analysis, you can see at a glance the progress status of the analysis.
The analysis consists of three steps:
the Properties definition,
the Scan, and
the Verification.
1. Open an analysis.
The analysis information is displayed, and you can see the following tabs on the left:
Properties
Scan
, and
Verification
161150-541 - A
,
.
5-27
ScanRDI
2. Check the progress status icon of the different tabs:

The step is complete. You can perform the next step if
there is one.
You aborted the step or one or more errors occurred.
You cannot perform the next step.
The step is not complete or there is a problem, but you

can still perform the next step.
Some examples of problems:
There is some information missing in the Properties
definition but you can still perform the Scan step and fill in
the Properties definition later.
The reagents/consumables have expired.
No step
status icon
The step has not been performed.
Checking the analysis result status

Note: In the Analysis ID panel, you can see at a glance the result status of the analyses.
IMPORTANT: The result status cannot be displayed if the Properties definition, the Scan and the
Verification steps are not all OK ( ) (see Checking the analysis progress status on
page 5-27).
2. In the Analysis ID panel, check the icon for the required analysis:
The analysis result is below the warning threshold

defined in the analysis protocol.
The status is OK.
The analysis result has reached the rejection
threshold defined in the analysis protocol.
The status is Rejected.
The analysis result is between the warning and
rejection thresholds defined in the analysis protocol.
The status is Warning.
161150-541 - A
5-28
ScanRDI
Checking the analysis error status

The required session must be loaded and the Session panel displayed.
1. Check the Status column in the Session panel:
No error has been encountered in the analysis.
One or more errors have occurred.

Check the tool tips for more information by placing your mouse over the
icon (
Empty
).
The analysis is still in progress.
Consulting the verified analysis map

The Properties definition, the Scan and the Verification steps must have been performed.
3. Click on the Verification tab (
).
The verified analysis map is displayed.
Checking the protocol used for the analysis

IMPORTANT: The protocol selected when you created the analysis may have been edited since you
created the analysis. The ScanRDI software keeps track of changes.
The analysis must have been performed.
1. Click on the required analysis in the Session panel.
2. Click on the Properties tab.
If the following icon (
) appears next to the protocol name, this indicates that the
protocol defined in the application has been edited since you created the analysis.
3. Click
to check the protocol used.
The protocol used for the analysis is displayed.
161150-541 - A
5-29
ScanRDI
Verifying an analysis
Note: Once the Scan step has been completed, you need to verify the detected events. To perform
the Verification step you need to verify and tag the events, according to what you see in the
microscope, as microorganism, particle, or unknown.
2. Make sure that the Properties definition and the Scan steps have been performed.
3. Make sure that the required membrane is placed beneath the microscope.
4. Make sure the CoolLED lamp of the microscope is on.
Displaying the Events map

2. Click on the Verification tab (
).
The Events map is displayed.
Zooming in/out on the Events map

1. Place your mouse over the map and move the scroll wheel up to zoom in, or down to
zoom out.
Selecting an event
Note: If you select events using the right arrow, you select the events in ascending order (example:
from event No. 9 to event No. 10 and so on).
If you select events using the left arrow, you select the events in descending order (example:
from step No. 77 to step No. 76 and so on).
1. Click on the left or right arrow of one of the following:
the ScanRDI software
the ScanRDI keypad
your PC keyboard
OR
1. Click directly on an event with your mouse.
The event is selected and its number (Event No.) is displayed in the bottom left hand
corner.
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5-30
ScanRDI
Verifying events
The total number of events present on the Events map is indicated in the right column
(Events).
1. Make sure the intended event is selected on the Events map.
2. Check in the microscope.
3. According to what you saw, click on one of the following (on the software or the keypad):
P
To tag the event as a Particle.

The event is tagged with a white square on the map.
To tag the event as a Microorganism, i.e. a bacterium.

The event is tagged with a red cross on the map.
To tag the event as Unknown, if you are not certain of what it is.
The event is tagged with a cyan circle on the map.
Example of an Events map containing verified events:
In the Verification section of the right column, you can see the amount of events in each
category once you have verified them.
4. Look at the counter in the right column to check the remaining

amount of events to be verified in order to complete analysis
verification.
The next event is automatically selected to continue the
verification until the counter reaches 0.
A beep notifies you when the analysis result interpretation is available.
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ScanRDI
Generating a session report as a .pdf file
5. Click
to stop the Verification step.
The Verification step is complete and the analysis is verified.
OR
Click
to continue the Verification step.
Note: Events tagged as Unknown are not taken into account by the counter.
Commenting on an event
1. Select an event.
2. Click
The Comment on Event window is displayed.

3. Enter a comment about the selected event.
4. Click
to save the comment.
You can consult the comment in the Comments field of the analysis properties.
Saving a verified analysis map

You must have finished verifying and tagging the events.
IMPORTANT: Once you have saved a verified analysis, the verification is considered complete and
can no longer be edited.
1. Click Save to save your verified analysis map.
The verified analysis map is saved and the Save button is disabled.
Generating a session report as a .pdf file

IMPORTANT: You may generate a signed or not signed session report for traceability (see Signing a
session on page 5-20). The session report format makes it impossible to edit after
generation.
Note: The session report layout may be customized (see Configuring a report on page 5-44).
The Session panel is displayed.
2. Click
A .pdf file with all the session information is automatically generated.

You may print it out or save it to your PC.
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Exporting data
Exporting data
Exporting a session as a .csv file
The Session panel is displayed.
2. Click
The Export session window appears.

3. Click
to select a destination folder.
4. Enter the filename and click Open.

5. Click
to export the session.
The .csv session file is exported to your destination folder.
Exporting an analysis as a .csv file

2. Click
The Export analysis window appears.

3. Click
to select a destination folder.
4. Enter the filename and click Open.

5. Click
to export the analysis.
The csv analysis file is exported to your destination folder.
Generating a view of the current active screen as a .pdf file

Note: You can quickly generate a view of the current Session panel, specific analysis properties and
map.
1. Display one of the following:
the Session panel,
the Analysis properties panel, or
the analysis map in the Verification panel.
2. Click
Your current view is generated as a.pdf file.
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Managing advanced analysis features

Displaying plots of an event
IMPORTANT: You must have the required access rights to manage these advanced features. See
User access rights on page 5-12.
1. Display the Events map.
Displaying 2D plots of an event

1. Select an event.
The 2D plots of the selected event are displayed by default.
Displaying 3D plots of an event

1. Select an event.
2. Click
The display options appear.

3. Select the 3D mode check box.
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The 3D plots of the selected event are displayed.
4. Click
to hide the display options.
Choosing the channels to display

1. Select an event.
2. Click

3. In the Channel selection drop-down list, select one of the following:
1st and 2nd channels
1st and 3rd channels
2nd and 3rd channels
The corresponding channels are displayed.
4. Click
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Choosing the axis to display with 2D plots

Note: You can only choose the axis to display with the 2D plot option.
1. Select an event.
2. Click

3. In the Axis selection drop-down list, select one of the following:
X axis
Y axis
The corresponding axis or axes are displayed.
4. Click
Displaying the plot grid lines

1. Select an event.
2. Click

3. Select the Grid lines check box.
The plot grid lines are displayed.
4. Click
Hiding the plot grid lines

1. Select an event.
2. Click

3. Unselect the Grid lines check box.
The plot grid lines disappear.
4. Click
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User access rights on page 5-12
The session must be unlocked.
A first analysis must have been performed and the Events map must be displayed.
1. In the right column of the Verification panel, click New.
The Verification manager window appears.
2. Enter the new Verification ID and click
The Events map is displayed with no tags.

3. Verify the analysis (see Verifying an analysis on page 5-30).
Once you have verified and tagged the required number of events, a beep notifies you
when the analysis result interpretation is available. The Verification window appears.
4. Click
The Verification step is complete, the automatic result interpretation of the analysis is
produced and the new verification is automatically saved.
OR
Click
to continue the Verification step.
Note: To consult either the first or second verification:

Click on the required analysis in the Analysis ID panel and select the required verification in
the Verification manager window. The required verified analysis map is displayed.
Consulting event discriminants

An analysis must have been performed and the Events map must be displayed.
1. Click on the rightmost
The event discriminant types are displayed.

2. Select an event on the map.
The discriminants of this selected event are displayed.
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Note: You can quickly generate a view of the current Verification panel with 2D or 3D plots.
Generating a 2D plots view of an event

1. Display the Verification panel.
3. Click
Your current view of the 2D plots is generated as a .pdf file.
Generating a 3D plots view of an event

1. Display the Verification panel.
3. Click

4. Tick the 3D mode box.
The 3D plots of the selected event are displayed.
5. Click
6. Click
Your current view of the 3D plots is generated as a .pdf file.
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ScanRDI
Managing administration settings

Managing security settings
1. Click
and select Preferences.
2. Click on the Security tab.

The security settings appear.
3. Define the following settings:
Min. User ID length
To define the minimum numbers of characters in the user ID.
Max. User ID length
To define the maximum numbers of characters in the user ID.
Min. password length
To define the minimum number of characters in the password.
Password cache size
To define the maximum number of passwords that can be stored in the cache for
each user account.
If you change your password and enter one of the passwords already stored in
this cache, the password is rejected and you are prompted to enter another one.
Validity period
To define the validity period of user accounts.

When the user account expires, you are prompted to enter a new password.
Warning period
To define how many days to warn users before an account expires.

You are notified every time you log on, until your account expires.
Max. connection
attempts
To define the maximum number of times you can try to log on to your account
with incorrect user credentials.
When you reach the maximum number of attempts, your account is locked. Only
the administrator can unlock it.
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Managing user accounts

Creating a user account

1. Click
and select User management.
The User management window appears.

2. Click
The user creation form appears.

3. Enter the User name and User ID.
4. Enter a password.
5. Re-enter the password to confirm it.
You can select the Show password check
box to make sure it does not contain any
errors.
6. Select the user account access level:
Routine user
Expert
Administrator (limited to 50 active accounts)
7. Select the user account status:
Active (user account in use)
Inactive (user account temporary not in use)
Note: The user account status is locked when too many failed connections occurred.
8. Click
to create the user account.
The newly created user account appears in the Users column and its related information
is displayed.
Note: The user account owner must then activate his/her account by changing the default password.
See Logging on to my account on page 5-14.
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Editing a user account

1. Click

2. Select a user in the Users column.
The user account information is displayed.
3. Click

4. Edit the required user account information.
5. Click
to save changes.
Activating a user account

1. Click

3. Click

4. In the User status drop-down list, select active.
The user account status is set to active.
Note: The user account owner must then activate his/her account by changing the default password.
See Logging on to my account on page 5-14.
Deactivating a user account

1. Click

3. Click

4. In the User status drop-down list, select inactive.
The user account status is set to inactive.
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Managing session settings
Locking a user account

1. Click

3. Click

4. In the User status drop-down list, select locked.
The user account status is set to locked.
Note: To unlock a user account, you must set the User status to active. See Activating a user
account on page 5-41.
Removing a user account

1. Click

3. Click
The Remove user window appears.

4. Click
to remove the user account.
The user account is removed.

Note: The user account remains in the Users column for traceability but its status is set to removed.

Setting the default session display

Note: You can choose which analysis-related information to display in the Session panel.
The default session display applies for all user accounts.
Displaying the data

1. Click
The General tab is displayed.

2. Right-click on any column header.
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ScanRDI
3. In the add column menu, select the required column to display.

The required column appears.
To arrange the column order:
4. Click on the required column and drag and drop it to the required location.
5. Click
to save changes.
Hiding the data

1. Click
2. The General tab is displayed..
3. Right-click on the column

header of the column you want
to hide.
4. Click Hide.
The required column
disappears.
5. Click
to save changes
Setting a session display for my account

Note: The session display setting only applies for the sessions you load with your account.
1. Display the Session panel.
Displaying the data

1. Right-click on any column header.
2. In the add column menu, select the required column to display.
The required column appears.
To arrange the column order:
3. Click on the required column and drag and drop it to the required location.
Hiding the data

1. Right-click on the column header of the column you want to hide.
2. Click on Hide.
The required column disappears.
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ScanRDI
Setting the user account inactivity timer

Note: After a certain time of inactivity, the current users account is automatically locked.
1. Click

2. Set the time in the Inactivity timer field.
The minimum time value that can be set is 300s and the maximum is 3600s.
3. Click
to save changes.
Note: Before generating a session report to a .pdf format, you can customize its display.
1. Click
Click on the Report tab.

2. Define the analysis table display in
the section Settings for the
selected column by:
Selecting a column and entering
a customized Title.
Selecting a column and entering
a Column width.
3. Define the paper settings.
You can define the size and the
orientation of the report.
4. Define the report header.
You can enter a report title, number
and reference, and also choose to
display certain company details.
5. Click
to define the company details.
6. Click
to preview the report display.
7. Click
to save changes.
The report configuration is saved.
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ScanRDI
Managing instrument settings
Managing instrument settings

Changing the interface language

1. Click

2. In the Language drop-down list, select a language.
3. Click
to save the language change.
4. Restart the ScanRDI software to apply the language change.
Selecting the device to use

1. Click
2. In the Instrument menu, select Device configuration.

3. Select the check box next to one of the following devices:
Instrument
Microscope
Keypad
4. Click
Instrument
The instrument connection is activated and the instrument is ready for use via the
ScanRDI software.
Microscope
The Microscope menu is enabled in the ScanRDI software.

1. Click
2. In the Instrument menu, select Microscope, and:

Click Microscope calibration to calibrate the microscope, or
Click Check home to check the microscope home position, or
Click Set home to set the microscope home position, or
Click Unload to unload the sample holder from the microscope plate.
Keypad
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The keypad connection is activated and you can use the keypad directly with the
ScanRDI software.
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ScanRDI
Managing daily control settings
Managing daily control settings

Activating/Deactivating the end-of-session daily control

Note: You can choose to force users to perform a daily control in order to sign a session.
Activating the end-of-session daily control

1. Click

2. Select the End-of-session daily control check box to activate the end-of-session daily
control.
Deactivating the end-of-session daily control

1. Click

2. Unselect the End-of-session daily control check box to deactivate the end-of-session
daily control.
Consulting daily control history

Note: All daily controls performed since the application was first installed are listed in the history.
1. Click
and select Daily control history.
The Daily control history window appears.

The history lists the daily controls performed over the last five days.
To display more daily controls:
2. Select the Enable check box to enable the filter function.
3. Click on the drop-down lists to select the user and daily control statuses.
The filtered daily control data are displayed.
4. Click on any column to sort the data in ascending or descending order.
5. Click
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to exit the Daily control history window.
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ScanRDI
Managing the audit trail
Managing the audit trail

Consulting the audit trail

1. In the Account Manager menu, select Consult audit.
The Audit trail window appears.
2. Click
to display the filter options.
The filter options are displayed.

3. In the User drop-down list, select the required user, or select none if you want all userrelated information to be displayed.
4. Select the date and time ranges in the Period fields.
5. Click
to apply the filter.
The filtered data is displayed.

6. Click
to exit the Audit trail window.
Exporting the audit trail

Note: You can export the audit trail to a .csv file, and you can also apply filters in order to export
more specific audit trails (see Consulting the audit trail on page 5-47).
1. In the Account Manager menu, select Consult audit.
The Audit trail window appears.
2. Click
to display the export option.
The export option (

3. Click
) is displayed.
4. Select a destination folder.

5. Change the filename of the audit trail export if required.
6. Click Save to export the audit trail.
7. Click
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to exit the Audit trail window.
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ScanRDI
Managing protocols
Managing protocols
Creating a protocol
1. Click
2. In the Protocol menu, select Configure protocols.

The Protocol configuration window appears.
3. Click
4. Define the protocol definition:

Name
Enter a name for the new protocol.
Application
Select the appropriate application file required to perform the analysis. You can
to see the application information details. The application file
also click
consists of the instrument configuration and the discriminant settings.
Reference
Protocol reference.
Reference
volume
Enter the volume according to which the analysis result is produced.

Example: the sample contains 13 bacteria per 100 ml.
Note: If you don't want to apply a computed analysis result based on a
reference volume then set this field to 0.
Filtration
volume
Enter the expected volume to be filtrated in order to get the sample.

Note: This volume shall be overridden when creating the analysis.
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Managing protocols
5. Define the protocol thresholds:

Note: The thresholds correspond to the limits for analysis result status.
Warning
Enter the value for analysis result from which the analysis result status changes
from OK to Warning. It will be disabled if it is equal to Rejection threshold
value.
Rejection
Enter the value for analysis result from which the analysis result status changes
from Warning status to Rejection status.
Note: If the analysis result is based on a reference volume, thresholds are applied accordingly.
6. Define the protocol verification information.
In order to optimize the required time to execute the verification step, it is possible to produce
an analysis result interpretation based on a partial verification.
Example: An analysis where 50% of the events have been verified and 5 bacteria have been
confirmed, the analysis result interpretation will be 10 bacteria.
The following parameters are used to set the according rules to apply.
Note: Applied rules must be defined by the customer. It is recommended that the customer validate
those rules based on statistical studies for the targeted sample matrix.
Minimum
effort
Enter the minimum verification coverage (in percentage) required to permit the
production of an interpreted analysis result. It is not recommended to set a
minimum effort lower than 50%.
If automatic result interpretation is not allowed, set the value to 100%.
Absolute
minimum
effort
Enter the minimum number of events to verify to enable automatic result

interpretation, in order to complete the Verification step.
You must verify all these events; this rule takes precedence over the Minimum
effort rule.
Absolute
maximum
effort
Enter the Absolute maximum effort: in case of too numerous events,

verification operation may be too longer and may trouble the analysis flow for the
day. In such case it is possible to notify the operator with a message proposing
him to stop the verification when he has reached a specific number of verified
events.
You can set the value between 1 and 500. A typical setting is 100.
Note: Stopping the verification when the Absolute maximum effort is
reached does not take precedence over automatic result
interpretation rules, and Verification may be considered as
incomplete.
Randomize
events
By selecting the Randomize events check box, and when partial verification is
allowed, you verify events on the map randomly, rather than in order.
7. Click on the Reagents/Consumables tab.
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Managing protocols
8. Click
and fill in the following fields referring to protocol documents provided by
bioMrieux Application Specialists:
161150-541 - A
Reference
is the product reference provided by bioMrieux.
Designation
is the product name.
Barcode ID
is the unique product ID as defined in the barcode.
Barcode type
is the barcode format.
9. Click
to save the new protocol.
10. Click
to close the Protocol configuration window.
5-50
ScanRDI
Managing protocols
Editing a protocol
1. Click

3. Select the required protocol in the protocol list.
4. Click

5. Edit the required protocol information.
6. Click
to save changes.
7. Click
Duplicating a protocol
1. Click

4. Click
The duplicate protocol is displayed. The name of the protocol is followed by _1.
5. Edit the protocol information if necessary.
6. Click
to save the duplicate protocol.
7. Click
Deleting a protocol
1. Click

4. Click
5. Click
to confirm.
The selected protocol is deleted and disappears from the protocol list.
6. Click
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ScanRDI
Managing applications
Exporting a protocol
7. Click

10. Click
11. Select the destination folder and click on Choose.

The protocol has been exported to the selected destination folder.
12. Click
Importing a protocol
1. Click

3. Click
4. Select the protocol to import and click Open.

5. The imported protocol appears in the protocol list.
Click
Managing applications
Exporting an application
1. Click
2. In the Protocol menu, select Configure applications.

The Application configuration window appears.
3. Click
4. Select the destination folder and click Choose.

The application is exported to the selected destination folder.
5. Click
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to close the Application configuration window.
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ScanRDI
Consulting information about the ScanRDI software
Importing an application
1. Click
2. In the Protocol menu, select Configure applications.

The Application configuration window appears.
3. Click
4. Select the application to import and click Open.

The imported application appears in the application list.
5. Click
to close the Application configuration window.
Consulting information about the ScanRDI software

1. Click
The About window appears.

2. Click More to access advanced information.
The Operating system and Memory information are displayed.
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ScanRDI
User Maintenance
To get servicing contact information, contact bioMrieux or your local distributor (contact
information available on www.biomerieux.com).
Cleaning Procedures
CAUTION
Do not use benzene, thinner or any volatile substances to clean the

ScanRDI. These chemicals may damage the cabinet finish.
1. Turn off the instrument, computer and peripherals.

2. Dust the surfaces by wiping the cabinet with a soft clean cloth.
Decontamination Procedures
This procedure is performed using an Ultrasonic cleaner at the end of the day, to ensure the
cleanliness of the equipment.
Material
Ultrasonic Cleaner Model 3210 (by Branson Ultrasonic BV, Soest /Holland) or equivalent.
Reagent
General Purpose Cleaner concentrate (by Branson ultrasonic BV, Soest /Holland) or
equivalent.
0.22 m filtered water (e.g. Millipack 200 Cartridge).
70% v/v Ethanol
Preparing the cleaning solution

1. Mix 1 volume of General Purpose Cleaner + 8 volumes of sterile water (0.22 m filtered
water).
2. Change the cleaning solution periodically (twice a week).
3. Before using the fresh cleaning solution, degas it in the working ultrasonic cleaner for 5
to 10 minutes.
Cleaning the membrane holder

1. Check the level of the cleaning solution.
2. Place the items (membrane holders) into the tray
3. Cover with the perforated lid.
4. Set the time to 10 minutes.
5. Slowly lower the tray into the tank.
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Decontamination Procedures
User Maintenance
6. After the 10 minutes of ultrasonic cleaning, remove the items from the cleaner.
7. Rinse them with sterile water (0.22 m filtered water), and with Ethanol 70%.
Note: Never autoclave the membrane holders. Allow them to dry under the laminar flow hood.
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Appendix - Configuring the barcode reader

1. Scan all the barcodes from top to bottom.

!
"
2. Wait one second and scan
!
"

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Appendix - Troubleshooting
Error Messages and Recovery Procedures

This section lists the possible error messages and general problems that could occur when using the system.
Table B-1: Problem Resolution of the ScanRDI system
Error Message / Problem
Cause
Resolution
Power indicator on analyzer is off.
No power.
Check that:
the ScanRDI system is connected to
the main power supply.
The key switch is on.
The Fuse is FS OK.
Microscope does not move when the

joystick is moved
Microscope does not move when

you click on a scan map event.
Something physically interferes with

the microscope motion.
Check that nothing physically interferes

with the microscope motion.
The joystick cable is disconnected
Check that the joystick cable is connected

to the analyzer and secured.
The microscope cable is

disconnected
Check that the microscope cable is

connected to the joystick and secured.
The Move microscope check box

has not been selected.
Check that:
1. The microscope moves using the
joystick.
2. The Move microscope check box has
been selected.
Error message: Response not

received from microscope.
The validation has not been started.
Check that Begin validation has been

selected.
The microscope is disconnected.
Check that:
1. The microscope moves using the
joystick.
2. The USB cable is connected to the PC
and to the analyzer and secured at both
ends.
3. Perform the Reset instrument
procedure from the Log Window File
menu.
Nothing is seen under the

microscope when an event is
selected on the scan map.
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The check boxes for moving the

microscope have not been selected.
Check that the Move Microscope or

Begin Validation check boxes have been
selected.
The microscope focus is not set.
Check that the microscope focus is OK.
The membrane has moved.
Check that the membrane did not move

between the scan and the microscope.
The microscope is not aligned.
Check that the microscope alignment has

been done (Set Home procedure) and
verified (Check Home procedure).
The membrane has dried out.
Check that the membrane is still wet.
The microscope offsets need to be

redefined.
Please contact your local bioMrieux

representative to assist you with this.
B-1
ScanRDI
Troubleshooting
Table B-1: Problem Resolution of the ScanRDI system

Error Message / Problem
Cause
Resolution
Drawer does not open on command. The instrument is off
1. Check that the Instrument is powered up

and the application software is running.
2. In the ScanRDI software, click
3. In the Instrument menu, select
Communication reset.
The application attempts to establish a
connection with the instrument.
4. If the instrument connection fails again,
contact the support team.
Sample loaded not detected
The holder was present in the

analyzer when the system was
powered on.
Open and close the drawer with the holder

in place.
Keypad is inoperative.
The validation has not been started.
Check that the validation has been started.
The joystick cable is disconnected.
Check that the joystick cable is connected

to the analyzer and secured.
Barcode reader is not correctly

configured.
Refer to the Appendix Configuring the

barcode reader.
The used barcode reader has not

been provided by bioMrieux.
Use the barcode reader provided by

bioMrieux.
The barcode reader does not

operate properly.
Please contact your local bioMrieux

representative.
Barcode reader does not read

correctly traceability information
Table B-2: Resolving Problems with the ScanRDI software

Error Message /
Problem
Cause
Resolution
Log screen Scan button

remains
inactive (greyed out).
The current session is locked.
Unlock the session.
The System Status

indicates Serial Comms
failure.
You cannot perform any
steps that require the
instrument to be connected
correctly to your PC.
Cables are disconnected
Make sure that the instrument cable is connected to

your PC.
No power
Make sure that the instrument is turned on.
No connection with the instrument

The application attempts to establish a connection
with the instrument.
If the instrument connection fails again, contact the
support team.
The System Status

indicates
Scanner Not Ready
A problem has been reported by the

scanner driver card inside the
analytical module.

support team.
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Troubleshooting
Table B-2: Resolving Problems with the ScanRDI software

Error Message /
Problem
The System Status
indicates
Shutter Failure
Cause
Resolution
The laser power status is incorrect

support team.
The System Status

indicates Drawer Failure
The sample drawer failed to open or

close properly.

support team.
The System Status

indicates
PSU Not Ready
One of the power supply unit

voltages is missing or incorrect.
1. Turn off the ScanRDI
The System Status

indicates
Sample Not Loaded
The sample holder sensor does not

recognize the presence of a sample
holder in the analytical module
although it is there.
Try to open the sample drawer and close it again.
The System Status

indicates
Laser Powering Up
is present for more than 2
minutes after having started
The laser failed to start properly.

support team.
the ScanRDI or appears

in between scans
The System Status
indicates
Laser Warming Up is
displayed during 10 minutes
(default) after having started
2. Contact the support team.
The laser warming up process is in

progress.
Wait for the end of the warm up time.
A condition exists which prevents

the instrument from operating but
the application software is unable to
pinpoint its cause.
Shut down the system and restart it.
A duplicate session ID is present in

the source.
Check your source.
Exported session file is corrupted.
Check your file.
A software exception occurred.
The software operation can continue.

In case of repetitive error:
1. create a bug report,
the ScanRDI.
The System Status
indicates
System Not Ready
Error29aduringImport
session
Error 29a
2. contact the support team.
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B-3
ScanRDI
Appendix - Glossary
ADC
AnalogtoDigitalCount
Analysis
The analysis consists of scanning, counting and discriminating the objects of interest found in
a specific sample, in order to identify potential micro-organisms.
At the end of the analysis, the user can examine the objects of interest to verify whether or not
they are micro-organisms.
Application file
The application file consists of the instrument configuration and the discriminant settings
required to perform an analysis.
Audit trail
The audit trail gathers all traceability-related information.
Control, daily
The daily control consists of assessing the instrument fluorescence detection capability, by
scanning standard beads and checking the mean measured intensity against a reference
called Mean Intensity Reference (MIR).
Event
An event is a discriminated object of interest detected during the analysis.
Events map
The Events map contains all discriminated data detected by the scan. The discrimination filter
has been applied and the Events map only contains objects of interest (events).
Discriminant, data
A data discriminant is a criterion used to filter out detected data to obtain potential microorganisms (events).
Mean Intensity Reference (MIR)
The Mean Intensity Reference (MIR) is the reference measure that is compared with the mean
measured intensity detected during the daily control.
Protocol
The Protocol consists of all the input data and materials required to execute an analysis.
It includes a reference to an application (instrument configuration and discriminant settings),
the list of material references (reagents and consumables), the volume to filter in order to
obtain the sample, the thresholds for the acceptance or rejection of the samples, and various
settings related to result verification.
161150-541 - A
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ScanRDI
Glossary
Session
A session consists of gathering a set of analyses. You can create, perform and verify the
sessions analyses.
Once you have performed and verified the sessions set of analyses, you can sign the session
and generate a report for traceability.
Sign a session
Signing a session consists of appending an electronic signature to the session and freezing
the data for further exploitation.
The electronic signature appears on the session report.
When a session is signed, it also means the work with the session is complete and the results
are no longer modifiable.
Verification
The Verification step consists of verifying whether or not the detected events are microorganisms. The events can be tagged as:
micro-organisms,
particles, or
unknowns.
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ScanRDI
Revision History
This section contains a summary of changes made to each released revision of this manual starting with part
number 161150-541 - A.
Change type categories:
N/A
Not applicable (First publication)
Correction
Correction of documentation anomalies
Technical change
Addition, revision and/or removal of information related to the product
Administrative
Implementation of non-technical changes noticeable to the user
Note: Minor typographical, grammar, and formatting changes are not included in the revision history.
Release Date
Part Number Change Type
Change Summary
2014/05
161150-541 - A N/A
First publication

Biomerieux ScanRDI Manual - English

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ScanRDI

161150-541 - A - en - 2014/07 161150-541

Safety Information ...................................................................................................... 2-1

Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

System Description and Basic Operations .............................................................. 3-1

System Installation and Configuration ..................................................................... 4-1

Workflow and Instructional Procedures ................................................................... 5-1

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

User access rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Locking a session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Importing a session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18

Setting the calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22

Choosing the channels to display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Generating a 3D plots view of an event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38

Editing a user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41

Setting a session display for my account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43

Setting the user account inactivity timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-44

Consulting daily control history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46

User Maintenance ....................................................................................................... 6-1

Appendix - Configuring the barcode reader.............................................................A-1

Appendix - Glossary ...................................................................................................C-1

Introduction to the System

Intended Use and Users

Benefits and Limitations of Use

Warning and Safety Messages

Introduction to the System

Introduction to the System

Introduction to the System

Introduction to the System

Consult Instructions for Use

Caution, consult accompanying documents

Contains sufficient for <n> tests

Introduction to the System

Keep away from sunlight

Fragile, handle with care

Protect from light

Keep away from magnetic field

Upper limit of temperature

Lower limit of temperature

Electric shock warning

Potential pinch-point warning

Hazardous magnetic field

Introduction to the System

Potential tip-over/crush hazard

Separate collection for waste electrical and

Environmentally friendly use period. Actual

Both direct and alternating current

Three-phase alternating current

Earth (ground) terminal

Protective conductor terminal

Frame or chassis terminal

ON (only for a component of the system

OFF (only for a component of the system

Equipment protected throughout by

bioMrieux recommends the evaluation of the electromagnetic environment before operating

This label indicates that there

This label indicates that for

This label indicates that the

Back of the ScanRDI analytical module

Caution - Class 3B Laser

Manufactured in the U.K.

Top of the ScanRDI analytical module

Caution - Class 3B Laser

System Description and Basic Operations