USER MANUAL

Version 6.2 and above

Copyright © 2023 Charles River Laboratories

Contents
1 INTRODUCTION ....................................................................................................................................... 5
1.1 About................................................................................................................................................... 5
1.2 Technical Support ............................................................................................................................... 5
1.3 License................................................................................................................................................. 5
1.4 Acceptable Character Usage ............................................................................................................... 6
2 GETTING STARTED................................................................................................................................... 7
2.1 Supported Languages.......................................................................................................................... 7
2.2 Minimum System Requirements ........................................................................................................ 7
2.2.1 Windows Server .......................................................................................................................... 7
2.2.2 Windows PC Client ...................................................................................................................... 8
2.3 Recommended System Settings.......................................................................................................... 9
2.4 EndoScan-V™ Services Installation Steps ............................................................................................ 9
2.4.1 Install Database and Service ....................................................................................................... 9
2.4.2 Add Users to Windows Groups ................................................................................................. 13
2.5 EndoScan-V™ Application and License Installation Steps ................................................................. 14
2.5.1 Install Application and Connect to Database ............................................................................ 14
2.5.2 Install License (Add Feature File) .............................................................................................. 19
2.6 Open EndoScan-V™ Application and Log In ...................................................................................... 20
3 NAVIGATING THE SOFTWARE ............................................................................................................... 21
3.1 Assay Icons ........................................................................................................................................ 22
3.2 Tools/Administration Icons ............................................................................................................... 23
3.3 Layout................................................................................................................................................ 23
3.4 Dashboard Icons................................................................................................................................ 23
3.5 Information Icons .............................................................................................................................. 24
3.6 Account Icon ..................................................................................................................................... 24
4 SETTINGS ............................................................................................................................................... 25
4.1 User Management ............................................................................................................................ 25
4.1.1 Default User .............................................................................................................................. 25
4.1.2 Default Privilege Groups ........................................................................................................... 26
4.1.3 Default Sample Group ............................................................................................................... 37
4.1.4 Users.......................................................................................................................................... 37
4.1.5 Privilege Groups ........................................................................................................................ 39
4.1.6 Sample Groups .......................................................................................................................... 42
4.1.7 Active Directory......................................................................................................................... 44
4.1.8 Import Windows Users ............................................................................................................. 46
4.2 Accessory Database .......................................................................................................................... 48
4.2.1 Manage Accessory Type ............................................................................................................ 49
4.2.2 Import from CSV........................................................................................................................ 51
4.2.3 Add Accessory ........................................................................................................................... 52
4.2.4 Modify/Create From ................................................................................................................. 54
4.2.5 Delete Accessory ....................................................................................................................... 54
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 4.2.6 Print Accessory Database .......................................................................................................... 55
4.2.7 Close Accessory Database ......................................................................................................... 55
4.3 Sample Database............................................................................................................................... 57
4.3.1 Import from CSV........................................................................................................................ 58
4.3.2 Add Sample ............................................................................................................................... 60
4.3.3 Modify/Create From ................................................................................................................. 63
4.3.4 Delete Sample ........................................................................................................................... 64
4.3.5 Print Sample Database .............................................................................................................. 65
4.3.6 Close Sample Database ............................................................................................................. 65
4.4 Instruments ....................................................................................................................................... 65
4.4.1 How to Add Instruments ........................................................................................................... 66
4.4.2 Add nexgen-PTS™ Instrument................................................................................................... 67
4.4.3 Add nexgen-MCS™ Instrument ................................................................................................. 70
4.4.4 Discover Nexgen Instruments ................................................................................................... 74
4.4.5 Add ELx808™ Instrument .......................................................................................................... 76
4.4.6 Add PRS Instrument .................................................................................................................. 80
4.4.7 Self-Test Report for ELx808IU™ and PRS Instruments .............................................................. 84
4.4.8 Add Nexus 200™ Instrument .................................................................................................... 86
4.5 Global Settings .................................................................................................................................. 86
4.5.1 General Tab ............................................................................................................................... 86
4.5.2 Security Tab............................................................................................................................... 90
4.5.3 Report Tab................................................................................................................................. 91
4.5.4 Microplate Tab .......................................................................................................................... 93
4.5.5 Cartridge Tab............................................................................................................................. 98
4.5.6 Nexus 200 Tab ......................................................................................................................... 100
4.6 Digital Signature Configuration ....................................................................................................... 100
4.7 Manage Locks.................................................................................................................................. 102
5 RESULTS............................................................................................................................................... 105
5.1 Results – Microplate Mode ............................................................................................................. 105
5.2 Results – Cartridge Mode................................................................................................................ 107
5.3 Results Options ............................................................................................................................... 109
6 REPORTS & DIGITAL SIGNATURES ....................................................................................................... 110
6.1 Microplate Reports ......................................................................................................................... 110
6.2 Cartridge Reports ............................................................................................................................ 116
7 IMPORT ............................................................................................................................................... 123
7.1 Importing .pltx Files ........................................................................................................................ 124
7.2 Converting .plt to .pltx Files ............................................................................................................ 124
8 EXPORT ................................................................................................................................................ 131
9 COPY FROM/CREATE TEMPLATE (MICROPLATE MODE ONLY) .............................................................. 133
9.1 Create Template.............................................................................................................................. 133
9.2 Copy From ....................................................................................................................................... 134
10 SETTING UP AND RUNNING A MICROPLATE ASSAY ............................................................................ 135
10.1 Adding Samples and Standard to the Template Grid...................................................................... 135

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 10.2 View List .......................................................................................................................................... 140
10.3 Print Grid ......................................................................................................................................... 141
10.4 Read Number and Read Time ......................................................................................................... 142
10.5 Well/Grid ......................................................................................................................................... 142
10.6 Standards and Samples Lists ........................................................................................................... 143
10.7 Assay Properties.............................................................................................................................. 144
10.8 Starting an Assay ............................................................................................................................. 150
11 CARTRIDGE MENU (CARTRIDGE AND NEXUS 200 MODES ONLY) ....................................................... 154
12 SETTING UP AND RUNNING A CARTRIDGE ASSAY (CARTRIDGE MODE ONLY) ................................... 157
12.1 nexgen-MCS™ Cartridge Panel........................................................................................................ 158
12.2 nexgen-MCS™ Assay Setup ............................................................................................................. 159
12.3 nexgen-MCS™ Run Assay ................................................................................................................ 160
12.4 nexgen-MCS™ Assay Result Screen................................................................................................. 166
12.5 nexgen-PTS™ Cartridge Panel ......................................................................................................... 166
12.6 nexgen-PTS™ Assay Setup Section .................................................................................................. 167
12.7 nexgen-PTS™ Run Assay.................................................................................................................. 167
12.8 nexgen-PTS™ Assay Result Section ................................................................................................. 173
12.9 nexgen-PTS™ Multiple Bays Display ............................................................................................... 176
13 AUDIT TRAIL ........................................................................................................................................ 177
13.1 Date Range Fields ............................................................................................................................ 178
13.2 Print Button..................................................................................................................................... 178
13.3 Search Criteria Field ........................................................................................................................ 179
13.4 Search Keyword Field ...................................................................................................................... 180
13.5 Show PC Name/PC Address Checkbox ............................................................................................ 180
13.6 Show Windows Username Checkbox.............................................................................................. 180
13.7 Display Time in UTC Checkbox ........................................................................................................ 181
13.8 Audit Entry Table............................................................................................................................. 181
13.9 Audit Trail Entries – Examples......................................................................................................... 183
14 BACK UP AND RESTORE DATABASE .................................................................................................... 186
14.1 Connect to Database ....................................................................................................................... 187
14.2 Backup Database ............................................................................................................................. 188
14.3 Auto-Backup.................................................................................................................................... 189
14.4 Backup Now .................................................................................................................................... 190
14.5 Restore Database ............................................................................................................................ 191

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1 INTRODUCTION
This section provides a brief introduction to the software, a list of supported instruments, technical support contact
information, license details, and guidance for the use of unsupported characters in the product.

1.1 About
EndoScan-V™ is an endotoxin detection and measuring software utilized to generate and report quantitative
Limulus Amebocyte Lysate (LAL) and recombinant Cascade Reagent (rCR) test data. Verified and validated to be
consistent with global regulatory agency requirements, the software performs the requisite calculations and
creates reports for product release or incoming testing. For added protection, it generates secure data files and
Audit Trails on all actions involving files and raw test data. The program was designed with flexible configuration
capabilities and performance options for gaining operational efficiencies. All aspects of the software form the
pillars of data integrity compliance: fully searchable Audit Trail, flexible user control and management, and reliable
data generation and backup.

List of instruments supported in EndoScan-V™ version 6.2:

 BioTek® ELx808IU™ Microplate Reader

 Endosafe® PRS 3 Microplate Spectrophotometer
 Endosafe® nexgen-MCS™ (Product Code MCS150)
 Endosafe® nexgen-PTS™ (Product Code PTS150)
 Endosafe® Nexus 200™ – Note: The Nexus 200™ is powered by EndoScan-V™ version 6.2 and above and has
its own User Manual with instructions on how to configure and navigate the automation interface.

1.2 Technical Support

Charles River
1023 Wappoo Rd. Suite 43B
Charleston SC, 29407

Phone: (843) 402-4900

Email: Endosafe-Support@crl.com

1.3 License
Be Advised: This computer program is protected by copyright law and international treaty. Unauthorized
reproduction or distribution of this software, or any portion of it, may result in severe civil or criminal penalties and
will be prosecuted to the maximum extent under the law.

EndoScan-V™ is developed with the following third-party software packages:

 Bouncy Castle
 Entity Framework
 Log4net
 Microsoft.NET
 .NET Systems
 NPGSQL
 SSH.NET

Each of these licenses is listed within the software and can be provided upon request.

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Warranty Disclaimer
The SOFTWARE is supplied “AS IS”. Charles River disclaims (to the fullest extent permitted by applicable law) all
other warranties and conditions, expressed or implied, including, without limitation, warranties of merchantability,
fitness for a particular purpose, non-infringement of third-party intellectual property rights, title, and those arising
by statute or otherwise in law form a course of dealing or use of trade. The user must assume the entire risk of
using the EndoScan-V™ Software.

Disclaimer of Damages

Charles River assumes no liability for damages, direct or consequential, which may result from the use of
EndoScan-V™ Software even if Charles River has been advised of the possibility of such damages. Any liability of
Charles River will be limited to refund of the purchase price. Charles River will not be liable for special, occasional,
non-pecuniary (moral), indirect or inconsequential damage or loss of profit, business, revenue, goodwill, personnel
costs or anticipated (cost) savings. In purchasing the SOFTWARE, you expressly release and discharge Charles River
from any and all such causes of action. Acceptance of delivery of the SOFTWARE shall be deemed agreement to
these terms and conditions. No document issued by you attempting to negate or otherwise modify the terms
hereof, including any purchase order or request for proposal, shall be binding upon Charles River.

1.4 Acceptable Character Usage

The following characters are not supported for the Sample Name, Sample Lot Number, Signature Meanings, or
Assay Comments:

All Languages: µ

German
Ää Éé Öö Üü ß «» „ “” ° € £

Italian

Àà Áá Èè Éé Ìì Íí Òò Óó Ùù Úú «» € ₤

French

Àà Ââ Ææ Çç Èè Éé Êê Ëë Îî Ïï Ôô Œœ Ùù Ûû Üü «» € ₣ ’

Spanish

Áá Éé Íí Ññ Óó Úú Üü «» ¿ ¡ € ₧ º ª ç

Brazilian Portuguese
Áá Ââ Ãã Àà Çç Éé Êê Íí Óó Ôô Õõ Úú

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 The following characters are not supported in the Instrument Serial Number or Assay Prefix/Suffix fields:
 < (less than)
 > (greater than)
 : (colon)
 " (double quote)
 / (forward slash)
 \ (backslash)
 | (vertical bar or pipe)
 ? (question mark)
 * (asterisk)

If one or more of these fields contains a character from this list and the database connection is lost, the system
will not be able to create the offline file used to recover the data once the connection is reestablished.

Control characters are not supported in the Sample Name field; using these characters may interfere with the
software’s ability to save the assay file. Control characters or non-printing characters (NPCs)are any characters
created by selecting the CTRL key on the keyboard and another key.

2 GETTING STARTED
This section covers supported languages, minimum system requirements, recommended system settings,
installation instructions for both EndoScan-V™ services and EndoScan-V™ software application, as well as
instructions on how to apply the license (or “Feature File”) and log in to the software application.

2.1 Supported Languages

EndoScan-V™ supports the following languages and translations:

 English
 French
 German
 Spanish
 Italian
 Portuguese (Brazilian)

Please review the Acceptable Character Usage section to identify any character limitations when using EndoScan-
V™ in your preferred language translation.

2.2 Minimum System Requirements

This section will provide minimum system requirements to run the EndoScan-V™ services and software application
on both a server and client PC.

2.2.1 WINDOWS SERVER

Operating System: Windows Server 2019 or Windows Server 2022 (64-bit) installed with Server with Desktop
Experience (GUI) feature active; Server Core is not supported.

CPU: Intel (6th generation Core or higher) or AMD (Ryzen 3 1200 or higher)
 Minimum clock speed of 1.4 GHz
 Compatible with 64-bit instruction set

Hard Disk: Minimum 10 GB of available space for installation and running the software.
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RAM: Minimum of 4 GB

.NET Framework: Version 4.6.1 or higher (Note: During installation, the software will check the version currently
installed; if necessary, the software will offer to install the minimum required version for you.)

Microsoft Visual C++ 2017 Redistributable: Version 14.14.26405 or higher (Note: During installation, the software
will check the version currently installed; if necessary, the software will offer to install the minimum required
version for you.)

Languages
 Operating System: Supported Languages Only
 Region Format: Supported Languages Only
 Display: Any Language (Note: For Sino-Tibetan languages such as Korean, Japanese, or Chinese, the “Region
Format” language setting must be set to English).

Other
 Only one (1) instance of EndoScan-V™ may be run on a workstation at a time; the system does not support
multiple Windows Users to run the application at the same time on the same workstation.
 Only one (1) instance of EndoScan-V™ version 6.0 (and higher) may be installed on a workstation at a time;
the system does not support the installation or operation of multiple versions of EndoScan-V™ on the same
workstation.
 This limitation applies to EndoScan-V™ 6.0 (and higher).
 The system will support multiple versions of EndoScan-V™ to be installed and run at the same time but only
if the first instance is version 5. (any) and the other instance is 6. (any).

2.2.2 WINDOWS PC CLIENT

Operating System: Windows 10 Pro/Enterprise (64-bit) or Windows 11 Pro/Enterprise (64-bit) – Note: Nexus 200™
only supports Windows 10 Pro (64-bit) at this time.

CPU: Intel (6th generation Core or higher) or AMD (Ryzen 3 1200 or higher)
 Minimum clock speed of 1.4 GHz
 Compatible with 64-bit instruction set

Hard Disk: Minimum 1 GB of available space for installation and running the software.

RAM: Minimum of 4 GB

.NET Framework: Version 4.6.1 or higher (Note: During installation, the software will check the version currently
installed; if necessary, the software will offer to install the minimum required version for you.)

Microsoft Visual C++ 2017 Redistributable: Version 14.14.26405 or higher (Note: During installation, the software
will check the version currently installed; if necessary, the software will offer to install the minimum required
version for you.)

Languages

 Operating System: Supported Languages Only

 Region Format: Supported Languages Only
 Display: Any Language (Note: For Sino-Tibetan languages such as Korean, Japanese, or Chinese, the “Region
Format” language setting must be set to English).

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2.3 Recommended System Settings

Display: Scaling should be set to 100% for all resolutions; users may increase to 125% when using a resolution of
1920x1080.

PC Power and Sleep Settings

Once established, communication between the EndoScan-V™ software and the instrument must not be
interrupted. This is especially vital when initiating, running, or completing assays as any communication disruptions
between the software and the instrument may result in the current operation being aborted.

To help in avoiding unintentional communication disruptions, please use the following configuration:
 Turn Off Monitor: Never
 Turn Off Hard Disk: Never
 System Standby: Never
 Hibernate: Never
 USB Selective Suspend: Disabled (instrument connects to workstation using a USB connector)

2.4 EndoScan-V™ Services Installation Steps

Before you get started, confirm you have the following:

 Services Install File
 Windows User Account with Local Administrator Privileges

Please review the Minimum System Requirements carefully before installing EndoScan-V™ Services.

Important! The Nexus 200™ system requires specific installation considerations and procedures; do not follow the
EndoScan-V™ Services installation steps for a system intended to run a Nexus 200™ instrument unless directed to do
so by a Charles River Laboratories technician. Please contact Technical Support for assistance with Nexus 200™
services or software installation procedures.

2.4.1 INSTALL DATABASE AND SERVICE

The following installation procedure is detailed using Windows 10 operating system; some differences between your system
and the images included for reference in this document are expected and should not be taken as a deviation.

The following steps will walk you through installing the EndoScan-V™ database and database services on either a
Server or Client PC machine. To get started, launch the Services InstallShield Wizard.

Locate the Services Install File (EndoScan-V_Services_Setup_[VERSION].exe), right-click and choose “Run as
Administrator”. If you do not have this file or if you are not sure which version to install, contact Technical Support
for assistance.

Step 1: Check For Prerequisites And Install Database

The install wizard will check our system for prerequisite software automatically. It checks for:

 Microsoft .NET Framework (minimum version 4.6.1)

 Microsoft Visual C++ 2017 Redistributable Package (minimum version 14.14.26405)
 Microbial Solutions Database (custom PostgreSQL)

If one (1) or more Microsoft applications are missing or do not meet the minimum version requirements, the install
wizard will display a list of the missing item(s) and offer to install the minimum version(s) for you.
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If all required Microsoft applications are present and meet the minimum version requirements, the install wizard
will only display a line item for the Microbial Solutions Database.

Select Install to download and install any

missing Microsoft application(s) and the
Microbial Solutions Database.

Step 2: Welcome
Here, the name and version of the service to be installed will be displayed. Review it carefully to confirm this is the
service and version you want to install.

Select Next to confirm and move forward to

the next step.

Step 3: License Agreement

Review the license agreement carefully. You may print a copy of the agreement by selecting Print.

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Select the Accept radio button to
acknowledge your acceptance of the terms of
the license agreement.

Select Next to confirm and move forward to

the next step.

Step 4: Customer Information

Enter the customer details for the person installing the service and database. This information is for recordkeeping
purposes only; it is not validated against any details in the software application or license key.

Enter the Username and Organization.

Select Next to confirm and move forward to

the next step.

Step 5: Ready to Install

This is the last chance to review or change any settings from the previous steps before installing the service. Once
the installation begins, a progress bar will display to track how long until the installation is complete.

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Select Install begin the service installation.

Step 6: Finish
If the installation of the service was successful, the install wizard will display a confirmation message which
includes the name and version of the service installed.

Select Finish to close the install wizard.

Note: If the installation fails, the install wizard will

display a message advising the installation could
not complete.

Please contact Technical Support for assistance.

Step 7: Perform a System Restart

Once finished, the install wizard will prompt users to perform a system restart to complete the installation and
initialize the service.

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Choose Yes to restart now or choose No to
restart later.

2.4.2 ADD USERS TO WINDOWS GROUPS

Once you have installed the database with service and performed a restart of the machine you will need to grant
specific Windows User accounts access to the database. These privileges are separate from the privileges assigned
to specific functionality within the software itself (see Privilege Groups for more details on that functionality).

 Endoscan-V Users group grants users read and write access to the database; this is required to perform
everyday work such as adding Sample Database records, running assays, or running reports.
 EndoscanAdmins group grants users local superuser access to the database; this is required to perform
higher-level actions such as database management.

These steps will walk you through adding Windows User accounts or groups to the Endoscan-V Users and
EndoscanAdmins Windows User Groups.

 Open the Windows Computer Management console by selecting Start and entering “Computer
Management” into the search bar.
 Navigate to System Tools then Local Users and Groups and select Groups.
 Locate the Endoscan-V Users group and add all Windows User accounts or groups which should have read
and write privileges to the database.
 Locate the EndoscanAdmins group and add all Windows User accounts or groups which should have local
superuser privileges to the database.
 Save your changes and close the Computer Management console window.

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 Image 2-1 Example image taken using Windows 10 OS; your OS version may display this window differently.

2.5 EndoScan-V™ Application and License Installation Steps

The following installation procedure is detailed using Windows 10 operating system; some differences between your system
and the images included for reference in this document are expected and should not be taken as a deviation.

Before you get started, confirm you have the following:

 Application Install File
 Database IP Address (confirm the workstation is able to communicate with the database server on port
18083)
 License File (“Feature File”)
 Windows User Account with Local Administrator Privileges

Please review the Minimum System Requirements carefully before installing the EndoScan-V™ Application.

2.5.1 INSTALL APPLICATION AND CONNECT TO DATABASE

These steps will walk you through installing the application software. Before you get started, please close all other
applications on the workstation including any antivirus software which may interfere or interrupt the installation
procedure.

Reminder: Only one (1) instance of the software application may be installed on a workstation at a time.
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To get started, launch the Application InstallShield Wizard.

 Locate the Application Install File (EndoScan-V_Setup_[VERSION].exe), right-click and choose “Run as
Administrator”. If you do not have this file or are not sure which version to install, contact Technical Support
for assistance.

Step 0: [EndoScan-V™ v. 6.2 and above only] Install Prerequisites

For EndoScan-V version 6.2 and above only, users must install the Gen5 driver required by the Endosafe® PRS
instrument. The install wizard for this version will prompt you to download and install this driver.

If EndoScan-V™ version 6.2 has been installed on the machine previously and the Gen5 driver from the previous
installation procedure is still installed and up to date, the install wizard will skip this step.

Select Install to install the prerequisite Gen5

driver.

Step 1: Welcome
Here, the name and version of the application to be installed will be displayed. Review it carefully to confirm this is
the application and version you want to install.

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Select Next to confirm and move forward to
the next step.

Step 2: License Agreement

Review the license agreement carefully. You may print a copy of the agreement by selecting Print.

Select the Accept radio button to

acknowledge your acceptance of the terms of
the license agreement.

Select Next to confirm and move forward to

the next step.

Step 3: Customer Information

Enter the customer details for the person installing the application. This information is for recordkeeping purposes
only; it is not validated against any details in the database or license key.

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Enter the Username and Organization.

Select Next to confirm and move forward to

the next step.

Step 4: Ready to Install

This is the last chance to review or change any settings from the previous steps before installing the application.
Once the installation begins, a progress bar will display to track how long until the installation is complete.

Select Install begin the service installation.

Step 5: Finish
If the installation of the application was successful, the install wizard will display a confirmation message which
includes the name and version of the application installed.

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Select Finish to close the install wizard.

Note: If the installation fails, the install wizard will

display a message advising the installation could
not complete.

Please contact Technical Support for assistance.

Step 6: Connect Application to the Database

Once the application is installed, you will need to connect the application to the database.

 Launch the EndoScan-V™ application.

 At the Login screen, select Settings from the menu then choose Connect/Restore Database.
 Database Address: Enter the IP address for the database server.
 Database Port: Confirm the port number is set to “18083”.
 Select Connect to Database to test the connection.
 Select OK to save your changes and close the window.

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2.5.2 INSTALL LICENSE (ADD FEATURE FILE)

Once you have installed the application and connected to the database, you will need to install the software license
(“Feature File”) for this instance. Each instance of the EndoScan-V™ application requires a separate Feature File to
license the software for that machine.

 Launch the EndoScan-V™ application.

 At the Login screen, select Settings from the menu then choose Add Feature File.
 Registration Key: No changes needed here; this field should come pre-populated.
 Feature File: Select the Windows File Explorer icon to browse for the Feature File. Select the file to add the
location to this field; the file extension for Feature Files is “.LIC”.
 Select Import to install the license for this instance of the application.

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If you have misplaced the Feature File for this instance of the application, contact Technical Support for assistance.
You will be asked for the Registration Key and to describe whether you need a Feature File for a server or client
instance of the application.

2.6 Open EndoScan-V™ Application and Log In

As part of the EndoScan-V™ software installation process, the install wizard also creates a shortcut to launch the
application on the machine’s desktop. However, if the shortcut is deleted for any reason, the application can be
launched from the executable in the application’s file directory, located by default in:

C:\Program Files (x86)\Charles River\EndoScan-V\EndoScanV.exe

The application opens on the EndoScan-V™ Login Screen.

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 Settings Menu:

 Connect/Restore Database – see section 14

 Add Feature File – as described above
 Help:
 About – Allows the user to review System Info and Save EndoScan-V™ logs
 Licenses
 Open User Manual

Into the “User” box type an appropriate username (if using the default Software Administrator account, type
“admin” (all lower case). In the “Password” box type the password for the entered user (if using the default
Software Administrator account, type “password” (again all lower case). Click “Login” (See section 0 for further
information).

The Software Administrator can then proceed to create new users and Privilege Groups so that the full functions of
the software can be set up.

3 NAVIGATING THE SOFTWARE

The EndoScan-V™ user interface presents differently based on which type of instrument is currently marked active
(or inactive) for the workstation. These different presentations are called “modes” and there are three (3) different
named modes: Microplate Mode, Cartridge Mode, and Nexus 200 Mode.

 Microplate Mode is for instruments which use a microplate to hold samples for testing (such as the BioTek®
ELx808IU™ and Endosafe® PRS).
 Cartridge Mode is for instruments which use a cartridge to hold samples for testing (such as the Endosafe®
nexgen-MCS™ and nexgen-PTS™).
 Nexus 200 Mode is for the Nexus 200™ system – Note: Please see the Nexus 200™ User Manual for more
information on this mode and the user interface which is not covered in this document.
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When no instrument is marked active, the system will default to a modified Microplate Mode with the special
addition of the Dashboard Icons (see the Dashboard Icons section for additional details). These options allow the
user to switch between the two modes to perform administrative tasks such as reviewing assay data, printing
reports, or any other tasks which do not require an active instrument connection to complete.

Finally, there is a special mode which only appears for the default administrative account “EndoScanV Installer”
(the account used for installation and account recovery). When this default user is logged in, only a limited number
of administrative menu options are available with no access to assay or instrument functionality; this is intentional
and may not be changed.

This section reviews a list of the icons in the Main Menu including a brief description of their function and notation
where relevant for which mode the option is linked with (if no mode notation is listed, the functionality is available
for all modes).

Example is in Microplate Mode with no active instruments; your interface may be different depending on which instrument type is currently active.

3.1 Assay Icons

New Assay (Microplate Mode Only)

Create a new assay using Copy From or Create Template.
(See Copy From/Create Template)

Results
Open the Assay Results window to view completed assay details.
(See Results)

Reports
Open the Reports window to view and print assay reports.
(See Reports & Digital Signatures)

Import
Open the Import window to import assay data in .pltx file format.
(See Import)

Export
Open the Export window to export assay data.
(See Export)

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 Cartridge (Cartridge Mode Only)
Open the Cartridge Menu to view cartridge-specific options.
(See Cartridge Menu).

3.2 Tools/Administration Icons

Settings
When selected, a user will be presented with a drop-down menu of options.
(See Settings)

Audit Trail
Open the Audit Trail window to view and filter Audit Trail events.
(See Section 13 Audit Trail)

Edit Password (Local Accounts Only)

Open the Change EndoScan-V™
Password window to edit the current
User’s password.

To change the password, enter the

old password, then input and confirm
a new password per the onscreen
instructions.

3.3 Layout

The Layout section provides the user with options as to what will be displayed on the screen. By checking the
boxes, those items will display as windows or tiles in the Dashboard; uncheck to hide.

Standard Sets and Sample Information display in the left-hand panel with the Accessory Database and Sample
Database appearing in the bottom window. The area they occupy can be adjusted by moving the window edge.

in Microplate
Mode

in Cartridge Mode

3.4 Dashboard Icons

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These icons only appear when there are no active instruments assigned to the workstation; see Instruments section
for details on changing an instrument’s active or inactive status.

Switch to Microplate Mode.

Switch to Cartridge Mode.

3.5 Information Icons

This icon refers to Help; if selected, a user will be presented with the Software
Manual.

Open the About window.

The About screen allows to you view

details such as Version and System
Information.

It also provides access download

EndoScan-V™ log files to help with
troubleshooting efforts.

3.6 Account Icon

This icon refers to Exit. When selected the software will shut down. If an assay is
running, a warning window will appear if a user attempts to Exit the Software.

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 This icon refers to Lock Software.
When selected, a user will lock their
account, and this can occur either
when the software is dormant or
when an assay is running. Locking the
software prohibits another user from
utilizing the software or instrument.
The user who locked the software or
another user with the appropriate
privilege can log back in again.

4 SETTINGS

When a user with appropriate privileges selects the Global Settings icon, a
drop-down menu appears with the following options:
 Accessory Database
 Digital Signature Configuration
 Global Settings
 Instruments
 Sample Database
 User Management
 Manage Locks

4.1 User Management

The User Management functionality allows end users to set up Users, Privilege Groups, and Sample Groups.

A Privilege Group is a set of privileges assigned to a user group. A Sample Group is a set of samples from the
Sample Database assigned to a group. Each user will be assigned to a Privilege Group and a Sample Group. Each
user can be a member of one privilege group. Each user can be a member of multiple Sample Groups.

The software will ship with the following Default Users, Default Privilege Groups, and Default Sample Groups.

4.1.1 DEFAULT USER

The software comes with one (1) default user account:

 Login Name = “admin”

 Full Name = “EndoScanV Installer”
 Default Password = “password”

Note: On the first login, the “admin” user will be prompted to change their password immediately. Do not reuse
the default password; when configuring new users, this will also be their default password until they change it on
first login to the database (see Users for more details).

The software does not allow any changes to the Full Name for the default user “admin”. This user cannot be
deleted from the software.
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4.1.2 DEFAULT PRIVILEGE GROUPS

The following are the default privilege groups:

“Software Administrator”, “Administrator”, “Manager”, and “User”.

The user “admin” will be assigned to the Software Administrator Privilege Group.

The Privilege Group “Software Administrator” (SW) cannot be edited. This Group can add and modify Privilege
Groups and Users. It can also enable and disable Users.

The Privilege Groups “Administrator” (A), “Manager” (M), and “User” (U) will have pre-defined privileges (listed in
the table below) enabled that can be modified. These groups cannot be deleted.

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The table below also details all available privileges available in the software.

Default Privilege Name Description

Privilege
Group

Global Settings – General General Assay Settings

Privileges in Global Settings

A Auto Export and Export File Path Allows the user to turn on auto export and configure the
auto export file path. Also allows the user to choose
export as CSV or XML. This field is a checkbox on the
Global Settings -> General Tab. Export File Path is a field
on the Global Settings -> General tab.

M/A Assay Name Prefix Allows the user to configure Assay Name Prefix. This field
is in Global Settings -> General tab.

M/A Assay Name Suffix Allows the user to configure Assay Name Suffix. This field
is in Global Settings -> General tab.

M/A Spike Recovery Range Allows the user to configure lower limit for spike
recovery. This fields are found in Global Settings ->
General tab.

M/A Include Headers in CSV Allows the user to include the headers for the CSV
report. This checkbox is in Global Settings -> General tab.

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 Default Privilege Name Description
Privilege
Group

U/M/A Auto Print Allows the user to set Auto Print. This field is in Global
Settings -> General tab.

M/A Allow Expired Accessories Allows the user to select the use of expired accessories
from the accessories database. This checkbox is in Global
Settings -> General tab.

A Require Comments for Global Allows the user to turn on comments for Global Settings
Settings Changes changes. This checkbox is in Global Settings -> Security
tab.

A Require Comments for Post Assay Allows the user to turn on comments for post assay
Changes changes. This checkbox is in the Global Settings ->
Security tab.

A Require Comment on Signature Allows the user to turn on comments for cancellation of a
Cancellation digital signature. This checkbox is in Global Settings ->
Security tab.

M/A Validation Terminology Allows the user to configure the Validation Terminology.
This field is in Global Settings -> General tab.

M/A Sample Limit Value Terminology Allows the user to configure the Sample Limit Value
terminology. This field is in Global Settings -> General
tab.

U/M Run Assay Allows the user of Standard Cartridge interface and
Microplate interface to perform an assay.
Note: This privilege is not applicable to the Nexus 200
interface.

Global Settings – Security Security Privileges in Global Settings

A Password Timeout – Days Allows the user to configure the number of days before
the user’s password expires. This field is in Global
Settings -> Security tab.

A Password History Allows the user to configure the number of previously

used passwords; these are checked when creating a new
password. This field is in Global Settings -> Security tab.

A Login Timeout – Minutes Allows the user to configure the number of minutes
before the user is locked out. This field is in Global
Settings -> Security tab.

A Password Attempts Allows the user to configure the number of password

attempts when logging into the software before being

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 Default Privilege Name Description
Privilege
Group

locked out of the software. This field is in Global Settings

-> Security tab.

A Password Warning – Days Allows the user to change how many days before a
password expires warning message appears. This field is
in Global Settings -> Security tab.

M/A Allow Login After Software Lockout Allows a user to login when another user has locked the
software.

A Password Reset Allows a user to reset passwords for all users.

A Server Backup Details Allows the user the ability to configure server backup
information. This field is in Global Settings -> Security
tab.

A Manage Locks Allows the user to remove a record lock.

Global Settings – Reports Report Privileges in Global Settings

M/A Report Logo Allows the user to configure logo for reports. This field is
in Global Settings -> Report tab.

M/A Logo Position Allows the user to configure the position of logos on
reports. This field is in Global Settings -> Report tab.

U/M/A View Reports Allows the user to View Reports.

U/M/A Print Report Allows the user to Print Reports.

M/A Lab Name Allows the user to configure the Laboratory Name for
reports. This field is in Global Settings -> Report tab.

M/A For Invalid Assay show N/A for Allows the user to select ‘For Invalid Assay show N/A for
Sample Value Sample value’. This checkbox is in Global Settings ->
Report tab.

A Add disclaimer to All Summary Allows the user to switch on and add text for report
Reports disclaimer for summary reports. This checkbox is in
Global Settings -> Report tab.

M/A Show Accessories in Report Allows the user to select ‘Show Accessories in Report’.
This checkbox is in Global Settings -> Report tab.

Global Settings – Microplate Layout Settings Microplate Layout Settings Privileges Global Settings

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 Default Privilege Name Description
Privilege
Group

U/M Number of Replicates Allows the user to configure the number of replicates
(microplate readers only). This field is in Global Settings –
Microplate tab.

M/A Configure STD/SPL/SPK/CTRL Colors Allows the user to select colors for these fields.
(microplate readers only). This field is in Global Settings -
> Microplate tab.

A Reaction Time Format Allows the user to configure the Reaction Time Format
for microplate assays. This field is in Global Settings ->
Microplate tab.

M/A Replication Direction Allows the user to configure the direction replicates will
set out on the template for samples and standards.
(microplate readers only). The field is in Global Settings -
> Microplate tab.

U/M Assay Properties Allows the user to configure assay properties (microplate
readers only). This is the right mouse click on the 96 well
layout that allows a user to access Assay Properties. The
user can also access Assay Properties via the multiple-cog
icon on the template grid.

M Create/Modify Templates Allows the user to create and modify template files
(microplate readers only).

M Delete Templates Allows the user to delete template files (microplate

readers only).

U/M/A Auto Stop Allows the user to select Auto Stop (Microplate readers
only). This checkbox is in Global Settings-> Microplate
tab.

M/A Automatic Creation of Spikes Allows the user to select automatic creation of spikes
(microplate readers only). This checkbox is in Global
Settings – Microplate tab.

U/M/A Standard Curve Orientation Allows the user to select STDs orientation of either
ascending or descending.

M/A Modify Standard Sets Allows the user the ability to modify the standard sets
(microplate readers only).

M Change Masked Wells (microplate Allows the user the ability to mask wells This field is in
readers only). Global Settings -> Microplate tab.

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 Default Privilege Name Description
Privilege
Group

U/M/A Modify Assay Sample Information Allows the user the ability to modify the sample
information in the Assay (microplate readers only).
Well/Group tab – Sample Name, Sample Lot number,
Sample ID Dil/Conc, Endo Limit, Associate Standards and
Sample Comments. It DOES NOT include Mask or
Spike/Standard Concentration or Automatic Creation of
Spikes. Note none of these fields are editable when the
Standard is selected in the Well Details window.

M/A Post Assay Changes Allows the user to make post assay changes to settings
that can alter the reported results. (microplate readers
only).

Global Settings – Microplate Calculations Microplate Calculation Privileges in Global Settings

M/A Regression Allows the user to configure the regression settings

(microplate readers only). This field is in Global Settings -
> Microplate tab.

M/A Default Collection Type Allows the user to configure the default collection type
(microplate readers only). This field is in Global Settings -
> Microplate tab.

M/A Polynomial Order Allows the user to configure the order when using
Polynomial Regression (microplate readers only). This
field is in Global Settings -> Microplate tab.

A # of Points to Use for MaxV Allows the user to configure the number of points to use
for MaxV used in the PQ. This field is in Global Settings ->
Microplate tab.

M/A Onset OD Allows the user to configure the Onset OD (microplate

readers only). This field is in Global Settings -> Microplate
tab.

M/A # of Decimals to Display for Allows the user to configure the number of decimals
Endotoxin Value. reported for Endotoxin Value. This field is in Global
Settings -> Microplate tab.

M/A CV Limit – Samples Allows the user to configure the Sample CV settings
(microplate readers only). This field is in Global Settings -
> Microplate tab.

M/A CV Limit – Standards Allows the user to configure the Standards CV settings
(microplate readers only). This field is in Global Settings -
> Microplate tab.

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 Default Privilege Name Description
Privilege
Group

M/A Default Spike Concentration Allows the user to configure the Default Spike
Concentration (microplate readers only). This field is in
Global Settings -> Microplate tab.

M/A Enable Validation Allows the user to select the Enable validation checkbox
(microplate readers only). This checkbox is in Global
Settings -> Microplate tab.

M/A Average Replicates Allows the user to Disable/Enable Average Replicates

(microplate readers only). This checkbox is in Global
Settings -> Microplate tab.

M/A Inline Spiking Allows the user to select the Configure Inline spiking
checkbox (microplate readers only). This checkbox is in
Global Settings -> Microplate tab.

M/A Show CV Prefix Allows the user to select the Show CV prefix (microplate
readers only). This checkbox is in Global Settings ->
Microplate tab.

M/A Spike Recovery for Unreacted Allows the user to select the Spike Recovery for
Samples – Use Zero Unreacted Samples – Use Zero. (microplate readers
only). This checkbox is in Global Settings -> Microplate
tab.

Global Settings – Cartridge Cartridge Privileges in Global Settings

M/A CV Limit – Cartridges Allows the user to Configure CV limit for Cartridges
(Cartridge Reader only). This field is in Global Settings ->
Cartridge tab.

M/A Display Sample Value by Channel Allows the user to select Sample Value by Channel
(Cartridge Reader Only). This checkbox is in Global
Settings -> Cartridge tab.

A nexgen Software Settings Allows the user to select the nexgen Software Settings
for Halting an Assay, detecting the sample early,
generating reports for aborted/halted assays, and setting
the sample size parameters.

Cartridge Menu Settings Cartridge Menu Privileges in Global Settings

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 Default Privilege Name Description
Privilege
Group

M/A Download logs Allows the user the ability to download logs from a
cartridge instruments or Save Test Reports (Cog) or Save
Audit Log (Cog).

M/A Download Results Allows the user the ability to download results from the
nexgen cartridge instrument.

Note: This privilege is not applicable for assays

performed using microplate readers.

M/A nexgen Instrument Software Update Allows the user the ability to update the nexgen
instrument software.

U/M/A Reconnect Allows the user the ability to reconnect a cartridge

instrument (Cartridge reader only).

U/M/A Shutdown Allows the user the ability to shut down or Restart the
connected cartridge instrument.

U/M/A Modify Cartridge Assay Sample Allows the user to add a sample by dragging/dropping
from Sample Database or another panel. They cannot
type directly into the panel.

Digital Signature Digital Signature Privileges in Global Settings

A Digital Signature Configuration Allows the user to configure the meaning of a signature
or change the name of a signature role.

M/A Cancel Digital Signatures Allows the user privilege to cancel a Digital Signature. See
Cancelation Hierarchy in Section 4.6 on Digital Signatures
in the manual.

SW/A Associate Digital Signature Roles Allows the user to associate a digital signature role with
with EndoScan-V™ Users EndoScan-V™ users.

Audit Trail Audit Trail Privileges in Global Settings

U/M/A View Audit Trail Allows the user to view the Audit Trail.

U/M/A Print Audit Trail Allows the user to create an Audit Trail for printing and
saving.

M/A Display Time in UTC Allows the user to select the Display the time in UTC time
zone checkbox in the Audit Trail window.

Accessory Database Accessory Database Privileges in Global Settings

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 Default Privilege Name Description
Privilege
Group

M/A Manage Accessory Types Allows the user to create new Accessory Types.

M/A Add/Create From/Modify Accessory Allows the user the ability to Add and Modify Accessories
in the Accessory Database.

M/A Delete Accessory Allows the user to Delete Accessories from the Accessory
Database.

M/A Print Accessory Database Allows the user to print Accessory Database List.

Sample Database Sample Database Privileges in Global Settings

M/A Add/Create From/Modify Sample Allows the user to add and modify a sample in the
Sample Database.

M/A Delete Sample Allows a user to delete samples from the Sample
Database.

M/A Print Sample Database Prints the Sample Database.

User Management User Management Privileges in Global Settings

M/A/SW Add/Modify Users Allows the user to add and modify users.

M/A Delete Users Allows the user to delete other users if there is no
associated activity for that user.

M/A Archive Users Allows the user to archive other users.

M/A/SW Add/Create From/Modify Privilege

Group Allows the user to create and modify Privilege Groups.

M/A Delete Privilege Group Allows the user to delete a Privilege Group.

M/A Add/Create From/Modify Sample

Group Allows the user to add/modify Sample Groups

M/A Delete Sample Group Allows a user to delete a Sample Group.

M/A/SW Enable/Disable Users Allows a user to enable a disabled user.

M/A/SW View Disabled Users Allows a user to view a list of disabled users.

M/A View Archived Users Allows a user to view a list of archived users.

M/A Reinstate User from Archived User Allows a user to reinstate a user from the Archived User
List List.

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 Default Privilege Name Description
Privilege
Group

Import/Export Import/Export Privileges in Global Settings

M/A Import Allows a user to import .pltx files.

M/A Export Allows a user to export data.

Instrument Instrument Privileges in Global Settings

M/A Add/Modify Instrument Allows a user to add and modify instruments.

M/A Delete Instrument Allows a user to delete an instrument.

Assay Properties Assay Properties Privileges in Global Settings

(Microplate only)

Allows a user to add/delete accessories on a specific

assay. Field is available in the Assay tab of Assay
U/M Accessories Properties.

Allows a user to select the Auto Stop checkbox on a

specific assay. Field is available in the Assay Tab of Assay
U/M Auto Stop Properties.

Allows the user to select the Automatic Creation of

Spikes checkbox on a specific assay. Field is available in
U/M Automatic Creation of Spikes the Well/Group tab of Assay Properties.

Allows the user to select the Average Replicates

checkbox on a specific assay. This field is available in the
U/M Average Replicates Calculations tab of Assay Properties.

Allows the user to change the Collection Type for the

specific assay. Field is available in the Collection tab of
U/M Collection Type Assay Properties.

Allows the user to change the CV Limit – Samples on a

specific assay. Field is available in the Calculations tab of
U/M CV Limit – Samples Assay Properties.

Allows a user to change the CV Limit – Standards on a

specific assay. This field is available in the Calculations
U/M CV Limit – Standards tab of Assay Properties.

Allows the user to change the Enable Validation

checkbox for a specific assay. This field is available in the
U/M Enable Validation Calculations tab of Assay Properties.

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 Default Privilege Name Description
Privilege
Group

Allows the user to change the Endotoxin Units setting for

a specific assay. This field is available in the Assay tab of
U/M Endotoxin Units Assay Properties.

Allows the user to change the Filter Wavelength setting

for a specific assay. This field is available in the Collection
U/M Filter Wavelength tab of Assay Properties.

Allows the user to change the Lab Name setting for a

specific assay. This field is available in the Assay tab of
U/M Lab Name Assay Properties.

Allows the user to change the Mask checkbox for a

specific assay. This field is available in the Well/Group tab
U/M Mask of Assay properties.

Allows the user to change the Onset OD for a specific

assay. This field is available in the Calculations tab of
U/M Onset OD Assay Properties.

Allows the user to change the Plate Temperature Setting

on a specific assay. This field is available in the Collection
U/M Plate Temperature tab of Assay Properties.

Allows the user to change the Polynomial Order on a

specific assay. This field is available in the Calculations
U/M Polynomial Order tab of Assay Properties.

Allows the user to select the Regression type for a

specific assay. This field is available in the Calculations
U/M Regression tab of Assay Properties.

Allows the user to select the Show CV Prefix for a specific

assay. This field is available in the Calculations tab of
U/M Show CV Prefix Assay Properties.

Allows the user to change the Spike Recovery range for a

specific assay. This field is available in the Calculations
U/M Spike Recovery Range tab of Assay Properties.

Allows the user to change the Spike Standard

Concentration for a specific assay. This field is available in
U/M Spike/Standard Concentration the Well/Group tab of Assay properties.

Allows the user to enable/disable the shake feature of a

U/M/A Shake microplate-type instrument, if applicable.

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 Default Privilege Name Description
Privilege
Group

U/MA Collection Time Allows a user to modify the Collection Time for an assay.

U/M/A Read Interval Allows a user to adjust the Read Interval for an assay.

Nexus 200™

Allows the user access to the Global Settings >Nexus 200

A Global Settings – Nexus 200™ Tab

A Run Nexus 200 Allows the user to access the Nexus ™ user interface.

4.1.3 DEFAULT SAMPLE GROUP

Sample Groups allow the end user to add samples set up in the sample database into specific groups. Users can
then be assigned to sample groups, therefore allowing them to only view specific samples.

 The Sample Group “All Samples” will be available with the full sample database as default. The software will
add any newly created entries into this group automatically.
 The Sample Group “All Samples” cannot be deleted.
 The Sample Group “All Samples” will be associated with all users by default.

4.1.4 USERS
 The Users tab displays Add, Modify, Archive, Delete, and Close buttons.

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  Only authorized users will be able to Add, Modify, Archive, and Delete Users.
 Users can only be deleted if they have been created in error and have no associated activity (they have
never logged into the software). The delete button will not be available for any users that have activity.

To Add a User, click on ‘Add’ and the following window will appear:

Example of the Add User window with the Example of the Add User window with the
“Windows” Account Type selected. “Local” Account Type selected.

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 Field Name Min. of Characters Max. of Characters
Login Name 3 100
Full Name 1 40
nexgen Username 1 12
Password 8 20
 Each Login Name and Full Name must be unique.
 nexgen Username is automatically generated from the first twelve (12) characters of the Full Name. Blanks
are converted to _ (underscores). For example, Full Name = “John Quincy Adams” will be recorded as
nexgen Username = “John_Quincy”.
 The Login Name and the Full Name may only contain the following characters: a-z, A-Z, 0-9, (underscore),
blanks (spaces).
 The software allows for a default password of “password”; this is optional when a new user is created. To
utilize this, select the checkbox next to “Use default password”.
 An authorized user can create a password and will be required to type it twice to confirm the entry.
 Either the default password (“password”) or a specific password must be provided when a new user is
created/edited.
 A user can edit their own Privilege Group if they have the authorized access, but the changes will not be
active until they log out and then log back in again.
 A checkbox to request a change of password upon first login is available for any new users created. This will
force the user to change their password when they first login.
 The software will not allow a user to create another user with the name “admin”.
 A user will be notified that their account will be disabled prior to the configured number of failed attempts;
the default is set to three (3) attempts.
 The Sample Group field is optional; the default system behavior is to assign all new User records to the “All
Samples” group. Users may be assigned multiple Sample Groups.
 The Account Type check box allows the user to distinguish the account based on whether it is a local
account or Windows (Active Directory) account. Active Directory allows the user to utilize their Windows
username and password to log in. The EndoScan-V™ login would follow the same security settings as the
Windows login.
 Selecting the Find User button allows the user to search for the Windows User by entering the Windows
Username or the user’s Full Name, depending on how Active Directory is configured. See Section 4.1.7 for
more information on Active Directory.
 The Status checkbox lets you know about the status of the User, whether the user is Enabled or Disabled.
 Password expired -> If the user is disabled, it may be due to the password being expired. This is set by the
software when using a local EndoScan-V™ account; passwords will expire at midnight on the day of
expiration.
 Enabled -> This is set by the software when the user is disabled after the configured number of attempts;
the user can be reset by a user with the appropriate privileges. This field is a checkbox. When a user is
enabled, the checkbox contains a check mark.
 Users can only be a part of one Privilege Group. However, a user’s Privilege Group can be changed by a user
with the appropriate permission.
 Digital Signatures: A user can be associated with a Digital Signature level as Analyst, Reviewer, or Quality
Control. They can be assigned to more than one Digital Signature.
4.1.5 PRIVILEGE GROUPS
 The Privilege Group tab displays Add, Modify, Copy, Delete, and Close buttons.
 Only authorized Users will be able to Add/Modify/Archive and Delete Privilege Groups.
 Privilege Groups can only be deleted if no users are associated with the group.

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  The button ‘Add’ or ‘Modify’ displays a window to add a Privilege Group and allows the user to choose the
listed privileges. The listed privileges are pre-stored in the database; they cannot be added to, modified, or
deleted. All privileges are listed in the table in Section 4.1.2.

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  A new Privilege group can be created and a description for the group can be added.
Field Name Min. of Max. of
characters characters
Privilege Group 1 25
Name
Description 0 200
 Those authorized can enable or disable privileges within a Privilege Group
 Once a Privilege Group is created, users can be added to the group in one of two ways. From within the
‘Add/Modify Privilege Group’ screen, highlight the user from the list and click on ‘Modify Users’; this will
take you to the Modify User Screen where the user’s Privilege Group can be edited. Navigating directly to
the ‘Modify User Screen’ will also allow a User Privilege Group to be edited.
 The list of privileges for a Privilege Group can be printed; click on the print button on the screen. The list can
be printed or saved as a PDF.
 Selecting ‘List View’ allows the user to change how the privileges are viewed. This toggles between a
category list and a comprehensive list with all privileges listed.

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  Selecting ‘Set Defaults’ will revert the privileges of the four built-in Privilege Groups to the original install
settings.
 When modifying or adding a Privilege Group, select ‘Update’ to save changes. Selecting ‘Update’ will close
the Privilege Group screen.
 Selecting ‘Cancel’ will not save any changes made to the Privilege Group.
4.1.6 SAMPLE GROUPS
 The Sample Group tab displays Add, Modify, Copy, Delete, and Close buttons.
 Only authorized Users will be able to Add/Modify/Copy and Delete a Sample Group.
 Sample Groups can only be deleted if no samples are associated with the group.
 Selecting ‘Copy’ will make a copy of the selected Sample Group.

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 Field Name Min. of characters Max. of characters
Sample Group Name 1 25
Description 0 200
 The ‘Add’ and ‘Modify’ buttons display a window to Add/Modify a sample group.

 A group name can be created and a description for the group can be added.
 The software will not allow duplicate Sample Group names.
 Those authorized can modify samples within a Sample Group.
 Once a Sample Group is created, users can be added to the group in one of two ways.
 From within the Add/Modify Sample Group screen, highlight the user from the list and click on ‘Modify
Users’; this will take you to the Modify User Screen where the user’s Sample Groups can be edited.
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  Navigating directly to the Modify User Screen will also allow a User’s Sample Groups to be edited.
4.1.7 ACTIVE DIRECTORY

Active Directory allows users to utilize their Windows login criteria with EndoScan-V™. This service stores domain,
user, user group, and security data. EndoScan-V™ will utilize the authentication services used by Active Directory.
Users will have the option to create either a Windows account or a local user account. If upgrading from a previous
version of EndoScan-V™ version 6, the users will be able to alter their accounts to utilize Active Directory. A user
can only be deleted provided there is no activity associated with that user.

 To Create a Windows Account Type, select the radio button next to Windows and then select Find User.

 To search for a user, enter the user’s Windows username and then Find User. Select either Domain, to
search for a user on the company domain, or Machine, to search for aser on the PC.

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  The user information will display in the User Info box. Select the user and then select OK. Selecting Cancel
will close the window.
 To Search for users based on more details, select the Advanced tab.

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  The user can then filter based on Login Name, First Name, Last Name, Display Name, Description, Email
Address, Employee ID, and/or Telephone Number. For each filter, select whether the field Starts With, Ends
With, Contains, or Exactly Matches the information typed into the field.
 The Account Type must be either Domain or Machine.
 Enter the Domain Name into the designated field, if known.
 When all available information has been entered into a filter field, select Find Users.
 The software may display a loading icon while the search is being performed. Beneath the loading icon, you
will find a cancel button. Selecting cancel will stop the search.
 If the user you are searching for does not display in the list, please check the fields entered and try again.
Ensure all fields are correct or try altering the filters used.
 When searching for a Domain User, ensure the PC is connected to the Network.
 The Clear Filters button will clear all filters. This allows a user to start with blank fields.
 When a search is successful, users will display in the box labeled with Login Name, Display Name,
Description (typically the user’s job title in the database), User Principal Name, SID (Security Identifier), and
Distinguished Name. Use the scroll bar at the bottom of the user list to scroll to the right or the left.
 Select the User and click OK. The Full Name, nexgen Username, and Password fields will be populated. The
Password information will be grayed out for security purposes.
 The user will then select the Privilege Group and Sample Groups. If using Digital Signatures, select the Roles
for this user from the drop-down list.
 When finished, select Add.
4.1.8 IMPORT WINDOWS USERS

This feature allows the user to import groups of Windows users, such as users grouped to a certain lab. On the
main User Management screen, under the Users tab, select Import.

The following window will appear:

 In the Group Name field, input the group of users you are searching for, such as QC Lab.

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  Select either the Domain or Machine radio button. Selecting the Domain radio button will search for
Windows groups on the domain. Selecting Machine will search for Windows groups located on the PC itself.
 Select Find Group to search for Windows groups.

 The user results will display in the fields below. The Group Info will display on the righthand side of the
screen.
 Select the users to be added, along with the Privilege Group, Sample Group(s) and Digital Signature roles.
When finished, select Import.
 If more information is needed to find the Windows Group, select the Advanced tab.

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  This screen allows the user to use filters to search for Windows groups to Import.
 The user can choose to filter by the Group Name, Display Name, or Description. Select the drop-down menu
next to the filter field to select Starts With, Ends With, Contains, or Exactly Matches.
 The user then selects Find Groups to search for Windows Groups.
 The user can search by Account Type by selecting either Domain or Machine. The Domain will search the
network for users.
 Select the desired group and then OK.
 The user can then select from the user list to add the users to the software. The users can be assigned to the
Privilege Group, Sample Group(s), and Digital Signature roles. Select Import when finished.

4.2 Accessory Database

The Accessory Database can be used to add all accessories routinely used in the laboratory into EndoScan-V™,
allowing for easy addition to assays and record of all accessories used. Example accessories include but are not
limited to LAL Reagent Water, pipettors, pipette tips, etc.

The Accessory Database window is divided into two sections. The top section is the Editor, and the bottom section
is used to view the Accessory Database. You can add and modify Accessories in the Editor.

Both sections are titled (Accessory Editor and Accessory Database).

Option buttons in the Accessory Database are as follows:

Button Functionality
Manage Accessory Types Allows you to add an Accessory Type for future use.
Import from CSV Allows you to import Accessories from a .CSV file.
Add Add a new record to the Accessory Editor.

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 Button Functionality
Modify Allows you to modify a record in the Accessory Editor.
Create From Copies a current Accessory(s) from the Database so
that you can use it to create a new Accessory.
Delete Deletes the Accessory(s) that is highlighted in the
Accessory Editor or in the Accessory Database.
Save Saves the current records in the Accessory Editor into
the Accessory Database.
Print Print a report of all the Accessories in the Accessory
database.
Close Closes the Accessory Database window.

4.2.1 MANAGE ACCESSORY TYPE

To ensure consistency of naming conventions, the Manage Accessory Type feature allows those users with the
appropriate privileges to name all accessories used in the facility. Other users creating accessory entries in the
database can then choose from this list. At installation there will already be a list of accessory types available in the
Manage Accessory Types as follows:

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These accessories are most frequently used in Bacterial Endotoxin Testing. The Added By and Added Date fields will
reflect the installation date.

Most Accessory Types may be deleted if they are not useful or to remove excessive clutter from the entries and
new ones can be added except for default Accessory Types. The following is a list of default Accessory Types which
may not be deleted: Cartridge, LAL, LAL Reagent Water, Other, Nexus Deep Well Plate, Nexus 1000 µL CO-RE tips,
Nexus 300 µL CO-RE tips, Nexus Reagent Container, and rCR.

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  To Add a new Accessory Type, type the new accessory type name in the field and click Add.
 To modify an accessory type, double click on the accessory type to be modified, then type the new name.
Highlight the row using the arrow button to the left of the Accessory Type and click on Save Selected.
 To Delete: Highlight the required Accessory Type using the arrow to the left of the Accessory Type and press
delete. A warning box will appear as follows:

 Click OK to confirm the deletion.

 To exit Manage Accessory Types, click Close.
4.2.2 IMPORT FROM CSV

A user can import an Accessory file but the .csv file must abide by the data rules outlined below.

A spreadsheet in Comma Separated Variable (CSV) format can be used to list details of accessories used in testing
external to the software and imported into EndoScan-V™. The rules below must be followed to ensure this file can
be imported successfully into EndoScan-V™ Version 6 or above.

To successfully import to the Accessory Database within EndoScan-V™, the CSV file needs to be in the CSV UTF-8
format to ensure all special characters are imported. In addition, the separation character for a CSV needs to be a
comma, not a semi-colon.

If importing to the Accessory Database via CSV, you cannot import from a file that is open; the software will state
that 0 of 0 records were imported.

Field Label/Column Valid Range?

Accessory Type Drop-down list in software

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 Field Label/Column Valid Range?
Accessory Description 1 to 100 characters for all Accessory Types except
for “Cartridge”; when Accessory Type is set to
“Cartridge”, no user input is accepted in this field.
Product Code 1 to 40 characters
Lot Number 1 to 40 characters
Calibration Code For cartridges only
Default n/a
Expiration Date Pop up calendar
Comments 1 to 255 characters
Added By n/a
Added Date n/a
Modified By n/a
Modified Date n/a

When importing, the user will receive a message reporting the number of successfully imported Accessories.

When you import an Accessory file, EndoScan-V™ creates a status file in .CSV format which opens automatically (in
your default program for opening .CSV formatted files) upon completion of the import. The Status file will list any
files that were not imported.

4.2.3 ADD ACCESSORY

To add a new Accessory record, select the Add button; to create multiple new records at once, select Add again to
add new rows to the Editor.

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Complete the Accessory details in each row as follows:

 Accessory Type: Choose from the drop-down options (this is a unique identifier field and must be chosen).
 Accessory Description: For all Accessory Types except for “Cartridge”, use this field to add a description or
further details about the Accessory record.
 When the Accessory Type is set to “Cartridge”, the Accessory Description field is disabled for user input.
Instead, when users enter a valid Lot Number and Calibration Code for the cartridge, the system will
identify and automatically update this field with the “Cartridge Type” value: IE LAL Cartridge, Glucan
Cartridge, LAL Cartridge, or rCR Cartridge.
 Product Code: A product code may be added; this may be the item/order code for that product.
 Lot Number: Is the Lot Number of the accessory (this is a unique identifier field and must be completed).
 Calibration Code: This field is only used for cartridges; both the lot number and calibration code need to be
completed when adding a cartridge type accessory (this is a unique identifier field for cartridges and must
be completed).
 Default (Microplate Only): If default is selected these defaulted accessories will automatically be added to
any newly created assay in Microplate Mode.
 Expiration Date: Choose the correct expiration date. Note: If cartridge lots are manually typed into the
cartridge panel, the expiration date will display as N/A on the report. The expiration date can only be edited
through the use of the Accessory Database.
 Comments: A comment on the accessory can be added.

Once the information has been completed, select Save to add the entries into the database.

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4.2.4 MODIFY/CREATE FROM

To modify an Accessory record or create a new one from an existing record, locate the record and select it to
highlight. Then, choose Modify in the toolbar to load the record into the Editor or choose Create From to create a
new record based on the details of an existing one.

Modifications to the entry can now be made to the selected row, or if Create New is selected a duplicate of the
selected accessory will appear in the editor.

Modify the record as needed in the Editor and then choose Save to submit the changes.

4.2.5 DELETE ACCESSORY

To delete an existing accessory, the user must highlight the row to be deleted either in the editor or in the
database. This is denoted by an arrow to the left of the accessory.

Select Delete; the following warning will appear:

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Select OK to delete the Accessory.

4.2.6 PRINT ACCESSORY DATABASE

To print a list of all accessories listed in the database, select Print. The user will be directed to a Print Preview page
where they can choose to print or save as a .pdf file.

If a user has searched for a selection of accessories, then when the print button is selected the Print Preview will
display only those selected accessories.

4.2.7 CLOSE ACCESSORY DATABASE

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To close the Accessory Database, select Close.

If items are still in the Accessory Editor, the following warning will appear:

Choose Cancel if you wish to return to the Accessory Database to complete edits. Or choose OK if you wish to exit.
If you choose OK any items in the Editor will not be saved.

Accessory Database Notes

Expired accessories will appear in red in the database. There is a global setting option to ‘Allow Expired
Accessories’; if this is not checked then a user would not be able to add an expired accessory to an assay. For
further information on this setting please refer to Section 4.5 (Global Settings).

The database can be searched by utilizing the search fields at the top of each column:

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4.3 Sample Database

The Sample Database can be used to add all samples routinely tested in the laboratory, allowing the user to easily
add samples to assays.

The Sample Database window is divided into two sections. The top section is the Editor, and the bottom section is
the Sample Database. You can add and modify samples in the Editor. Both sections are titled (Sample Editor and
Sample Database).

Option buttons in the Sample Database are as follows:

Button Functionality
Import from CSV Allows you to import Sample Information from a .CSV file.
Add Add a new record to the Sample Editor.
Modify Allows you to modify a record in the Sample Editor.
Create From Copies a current Sample(s) from the Database so that you can use it to create a new
Sample.
Delete Deletes the Sample(s) highlighted in the Sample Editor or in the Sample Database
Save Saves the current records in the Sample Editor into the Sample Database.
Print Print a report of all the Samples in the Sample database.
Close Closes the Sample Database window.

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4.3.1 IMPORT FROM CSV

A user can import a Sample file, but the .CSV file must abide by the data rules outlined below. Previous versions of
EndoScan-V™ do not provide the functionality to export the older product database to a .CSV file. Charles River can
provide a tool that allows the product database to be exported to a .CSV and provide support for this function.
Once the .CSV file is created this can then be imported into EndoScan-V™ version 6. If a spreadsheet in .CSV format
is already used to list details of samples tested which is external to the software, the rules below can be followed
to ensure this file can be imported as a .CSV into EndoScan-V™ version 6.

To successfully import to the Sample Database within EndoScan-V™, the .CSV file needs to be in the CSV UTF-8
format to ensure all special characters are imported. In addition, the separation character for a CSV needs to be a
comma, not a semi-colon. (Note that CSV stands for Comma Separated Variable).

When importing to the Sample Database via .CSV, ensure the micro sign (μ) is not in the file, as it does not act like a
normal character in Excel/.CSV. If you attempt to import it, EndoScan-V™ will not recognize it.

If importing to the Sample Database via .CSV, the Max Dosage needs to have a value (a zero can be added if field
not used) or the file will not import.

If importing to the Sample Database via .CSV, you cannot import from a file that is open. The software will state
that 0 of 0 records were imported.

Field Label Valid Range

Product Family 40 characters

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 Field Label Valid Range

Sample Name 120 characters, mandatory field. Control Characters cannot be used in the
Sample Name, as using these characters can interfere with the software’s ability
to save the assay. Control Characters are any characters that are utilized by
selecting the CTRL button on the keyboard and another key.

Sample Group(s) Allows the end user to add the samples to any sample groups that are set up in
User Management.
Sample ID 120 characters; mandatory field.

Max. Dosage 0-999999.999999

Units Any of the units listed in the drop-down box; mandatory field.

Starting Conc. Must be >0, with up to 6 decimal places. No more than 999999.999999. This
field is only used for concentrations when the concentration needs to be
diluted.
Dil./Conc. The Dilution/Concentration (abbreviated Dil./Conc.) valid range depends on the
Units selected. If the units are mL/mL or L/ML or device /mL then the valid
format is X:Y (which is a Dilution).
The valid range for dilutions is 1-999999999.999999. For device/mL the valid
format is X:Y, where X can be 1-999999 and Y can be up to 6 decimal places and
up to 999999999.999999. If the unit is device/mL then the number to the left of
the colon can be any whole. The concentration valid range is 0-999999.999999.
Default value is 1:1.

Total Dilution For Dilution: Calculated field based on the Pre-Dilution, Dilution #1, and Dilution
#2. This field should match the Dil./Conc. Field for the test dilution or
concentration.
For concentrations: Calculated field based on Starting Conc. Divided by the
Dil./Conc; this then completes the Total Dilution field.
Diluent #1 Drop-down menu of accessories
Dilution #1 In the form of 1:Y where Y can be up to 6 decimal places and up to
999999999.999999.
Diluent #2 Drop-down menu of accessories
Dilution #2 In the form of 1:Y where Y can be up to 6 decimal places and up to
999999999.999999.
Pre-Diluent Drop-down menu of accessories
Pre-Dilution In the form of 1:Y where Y can be up to 6 decimal places and up to
999999999.999999.
Endotoxin Limit Greater than 0

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 Field Label Valid Range

EU Criteria Blank, <, or ≤

Alert Limit 0-999999.999999
Auto Spike Yes or No
Spike Concentration 0-999999.999999

Performed With LAL or rCR

Comments 60 characters

Added By N/A
Added Date N/A
Modified By N/A
Modified Date N/A

When you import a Sample file, EndoScan-V™ creates an Excel spreadsheet status file that opens upon completion
of the import. The Status file will list any files that were not imported.

See example below: When importing, the user will receive a message reporting the number of successfully
imported Samples.

4.3.2 ADD SAMPLE

To add a sample, click Add. If multiple samples are to be created, a user can click on Add multiple times to create
multiple rows in the Editor.

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Complete the Sample details in each row as follows:

Note: If using Charles River Cortex™ software, you must restrict character length for sample name to a maximum
of 100 characters.

Field Label Description

Product Family Maximum 40 characters. User can choose to use a Product Family name for the sample;
this would be for grouping similar samples.
Sample Name Maximum 120 characters. User should enter a Sample Name for the sample (this is a
unique identifier field and must be completed).
Sample Group A user can choose what Sample Group the sample should be a part of. Default/Blank is
All Sample. For further information on Sample Groups please see Section 4.1 (User
Management).
Sample ID Maximum 120 characters. User should enter a Sample ID for the sample (this is a unique
identifier field and must be completed) must be completed).
Max Dosage User can enter the maximum dosage of the product in dosage units.
Units User should choose the units the sample is tested in; this will also denote the units the
results are reported in.
Options are: mL/mL, mg/mL, g/mL, L/mL, device/mL, Unit/mL, µg/mL, µL/mL and ng/mL
(this is a unique identifier field and must be completed).

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 Field Label Description
Starting The Starting Concentration field can be used if the user is diluting a concentration
Concentration further to obtain a testing concentration. The Starting Concentration is used in
calculating the Total Dilution when using multiple diluents or dilution steps.
For non-Nexus 200 users, this step can be added as an extra check on your process. For
Nexus 200 users, this is required if the robot is making dilutions on the deck. This field is
only required for concentrations, which are the following units: mg/mL, g/mL, Unit/mL,
μg/mL, and ng/mL.
Dil./Conc The user can enter the Dilution or
Concentration that the sample is routinely tested at following product validation.
The Dil/Conc valid range depends on the Units selected. If the units are mL/mL, L/mL, or
μL/mL, then the valid format is X:Y (which is a Dilution).
If the unit is mg/mL, g/mL, Unit/mL, device/ mL, μg/mL, or ng/mL then the number does
not require a colon separator (this is a unique identifier field and must be completed).
Total Dilution This is calculated by the software and a user cannot enter information into this field.
 For non-Nexus 200 users, these fields can be added as an extra check to
ensure the analyst performed these steps.
 For Nexus 200 users, this field will be the Total Dilution prepared either
off-deck and by the robot or just by the robot.
 If a pre-dilution step is needed prior to adding the sample to the deck,
the Total Dilution takes that dilution into account.

This field can be used for either concentrations or dilutions.

 For dilutions it is calculated based on the total amount of
dilutions added into the dilutions fields.
 For concentrations, this field is calculated using the Starting Conc.
And Dil./Conc.
Diluent #1 If a dilution step is made, Diluent #1 is a required field. This is a drop-down list of
accessories that can be used to dilute the sample.
This will not appear on standard Microplate or Cartridge reports; it will appear on Nexus
200 reports.
Dilution #1 This field can be used when making multiple dilutions of a sample.
For non-Nexus 200 users, this field acts as an extra check to ensure the analyst
performed the correct dilution. For Nexus 200 users, the robot will perform the required
dilution as the first step. This field can be used for either a concentration or dilution and
must be in the form of a ratio (1:Y).
This will not appear on standard Microplate or Cartridge reports; it will appear on Nexus
200 reports.
Diluent #2 If a dilution step is made, Diluent #2 is a required field. This is a drop-down list of
accessories that can be used to dilute the sample.
This will not appear on standard Microplate or Cartridge reports; it will appear on Nexus
200 reports.
Dilution #2 This field can be used when making multiple dilutions of a sample.
For non-Nexus 200 users, this field acts as an extra check to ensure the analyst
performed the correct dilution. For Nexus 200 users, the robot will perform the required
dilution as the first step. This field can be used for either a concentration or dilution and
must be in the form of a ratio (1:Y).

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 Field Label Description
This will not appear on standard Microplate or Cartridge reports; it will appear on Nexus
200 reports.
Pre-Diluent User can input a pre-dilution if the sample must be diluted off the deck of the Nexus 200.
If not using a Nexus 200, this field can be used as a third diluent field for multiple
dilutions.
This will not appear on standard Microplate or Cartridge reports; it will appear on Nexus
200 reports.
Pre-Dilution User can enter the Pre-Dilution, if the user is making a dilution off the deck of the Nexus
200. For non-Nexus 200 users, this field can act as a third dilution and act as a check on
the user’s dilutions. This field is used to calculate the Total Dilution.
This will not appear on standard Microplate or Cartridge reports; it will appear on Nexus
200 reports.
Endotoxin Limit User can enter the Endotoxin Limit of the Sample (this is a unique identifier field and
must be completed).
EU Criteria User can choose the EU Criteria to be used in the Endotoxin Value calculation. The
options are < or ≤.
NOTE: The ≤ option is only available for samples added to the sample database and then
dragged/dropped onto the assay. If sample information is typed directly into an assay
interface only the < criteria will apply.
Alert Limit User can enter the Alert Limit of the sample.

Auto-Spike User can choose if spikes (positive product controls) are automatically created on a new
(Microplate Mode assay. Default is set to Yes (this is a unique identifier field and must be completed).
only)
Spike Concentration User can choose the spike concentration if Auto-Spike is set to Yes. The default is set to
(Microplate Mode 0.5 EU/mL; this should be evaluated based on the Standard Set of the assay.
only)
Performed With User must select the reagent to be used with this sample; user may choose between LAL
and rCR.
Comments Maximum of 60 characters. A comment can be added on the sample.

It is important to note that the Predilution, Diluent #1, and Diluent #2 fields will only be reported in Nexus 200™
reports. They will not be reported for Cartridge or Microplate assays.

Once the information has been completed, select Save to add the entries into the database.

4.3.3 MODIFY/CREATE FROM

To modify an existing sample or create a new sample from an existing one in the database, the user must highlight
the row to be modified in the database. This is denoted by an arrow to the left of the sample:

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Click Modify or Create New and this will move the entry into the Sample Editor.

Modifications to the entry can now be made to the selected row, or if Create New is selected a duplicate of the
selected sample will appear in the editor.

Select Save to add the entry back into the database.

4.3.4 DELETE SAMPLE

To delete an existing sample, the user must highlight the row to be deleted either in the editor or in the database.
This is denoted by an arrow to the left of the sample:

Select Delete; the following warning will appear:

Select OK to delete the Sample.

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4.3.5 PRINT SAMPLE DATABASE

To print a list of all samples listed in the database, select print. The user will be directed to a Print Preview page
where they can choose to print or save as a PDF file.

If a user has searched for a selection of samples, then when the print button is selected the Print Preview will
display only those selected accessories.

4.3.6 CLOSE SAMPLE DATABASE

To Close the Sample Database, select Close. If items are still in the Sample Editor, the following warning will
appear:

Choose Cancel if you wish to return to the Sample Database to complete edits. Or choose OK if you wish to exit. If
you choose OK, any items in the Editor will not be saved.

Sample Database Notes

The database can be searched by utilizing the search fields at the top of each column:

4.4 Instruments

The Instruments function allows users to select which instruments they would like to use. There are three (3)
modes in EndoScan-V™: Microplate, Cartridge, and Nexus 200. When viewing the Results window, you will see
assays depending on the mode you are in.

EndoScan-V™ version 6.2 supports the following instruments:

 BioTek® ELx808IU™ Microplate Reader

 Endosafe® PRS 3 Microplate Spectrophotometer
 Endosafe® nexgen-MCS™ (Product Code MCS150)
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  Endosafe® nexgen-PTS™ (Product Code PTS150)
 Endosafe® Nexus 200™ – Note: This option only appears when a Nexus 200™ is available to connect.

All users will have access to the Instruments menu in Settings. Only those users with the privilege to Add/Modify or
Delete will be able to carry out these functions. Those without the privilege will only be able to activate and
deactivate instruments to allow them to switch between different instruments/modes.

Note: EndoScan-V™ version 6.1 (and higher) will no longer support running Endosafe® PTS100™ or MCS100™
instruments. Data that was run on these instruments is still available to view and print if run on a previous version
of EndoScan-V™ version 6. MCS100/PTS100 .pltx files (from version 5-5.5.5 SP3) can be imported into version 6.1
(and higher).

4.4.1 HOW TO ADD INSTRUMENTS

To add a new instrument, navigate to Settings in the main menu and select Instruments to open the Instrument
Manager window.

At the bottom of the Instrument Manager window select the drop-down menu on the Add button to choose a
specific instrument type; selecting the Add button directly will default to adding a nexgen-PTS™ instrument.

From here, you will add details and information specific for each instrument type you’d like to add. The following
sections review the specifics for adding each different instrument type: nexgen-PTS™, nexgen-MCS™, ELx808™;
PRS.
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Note: Only one (1) instrument type may be added at a time, the Add function is disabled while an assay is running,
and the Modify button will only be enabled when there is an existing instrument to modify.

The table below outlines the number of instruments per type that you can run using EndoScan-V™.

Instrument Type EndoScan-V™ version 6.2: Number of instruments that

can be connected concurrently.
nexgen-MCS™ Up to 3 (15 bays total)
nexgen-PTS™ Up to 15
Combination of Up to 15 bays total
nexgen-MCS™ & nexgen-PTS™
Elx808IU™ Up to 3
PRS Up to 3

 When multiple nexgen-MCS™ instruments are active, each instrument can display in its own tab; the tab will
be named with the serial number of the instrument.
 Multiple nexgen-MCS™ units can also be displayed in one tab, however, the tab name will be that of the
first instrument connected. Panel numbers should be numbered sequentially, 1-5 for the first nexgen-MCS™
and 6-10 for the second nexgen-MCS™.

4.4.2 ADD NEXGEN-PTS™ INSTRUMENT

Before you get started, make sure the instrument is powered on and the data cable is connected between the
instrument and the workstation. The steps in this section pick up where the How to Add An Instrument section left
off; if you haven’t already, return and complete the steps in that section before continuing with these instructions.

Along the bottom of the Instrument Manager window, select the drop-down menu for Add and choose “nexgen-
PTS” to open the Add/Modify Instrument dialog.

 IP Address – IP address of the nexgen-PTS™ instrument; example: 192.168.100.160. Users may find the IP
address in the instrument’s touchscreen interface menu under Network Settings.
 Description – Enter a description for this instrument; while not required, it’s helpful to add details such as
location or any special numbers or naming conventions assigned to the instrument to make it easier to
identify or recognize quickly.
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Pressing Add on this screen will prompt the software to connect to the instrument. When successful, the
confirmation message “Instrument successfully connected” will be displayed. The software picks up the serial
number of the instrument and the instrument type when it connects.

The software will display the nexgen Instrument(s) Bay Settings window. To add the instrument, check on the
Select checkbox and set the Tab and Panel numbers to 1. Click Add, and the software will confirm that the
instrument was saved successfully.

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Once in the Instrument window, you need to select the nexgen-PTS™ that you just added to be your Active
instrument.

The software will then show the new nexgen-PTS™ in the Instruments main window. To activate the nexgen-PTS™,
check the Active Instrument box as shown below.

Click Close. The system will activate the instrument, change to Cartridge Mode and display the nexgen-PTS™
Cartridge Panel in the dashboard.

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  Instrument Icon: Displays an icon of the
nexgen-PTS™ instrument.
 Tab and Panel Numbers: Example “2-1”
would refer to Tab #2 and Panel #1.
 Instrument Serial Number: Identifies the
instrument.
 Assay Name: Combination of Assay Prefix
(configured in Global Settings), Bay Serial
Number, Date (in YYYYMMDD format),
Sequence Number (set on the bay, reset
daily, increments with each new assay), and
Assay Suffix (configured in Global Settings).
 Status Indicator: See nexgen-PTS™ Cartridge
Panel Test Sequence for more details.
 Assay Setup: See nexgen-PTS™ Assay Setup
for more information.
 Assay Results: See nexgen-PTS™ Assay Result
Screen for more information.
 Test Sequence Message: See nexgen-PTS™
Cartridge Panel Test Sequence for more
information.
 Bay IP Address: Identifies the IP address of
the bay within the instrument.
 Cartridge Panel Menu: Opens the Cartridge
Panel Menu where users can download log
files, send commands to the instrument,
download results, etc.
 Cartridge Type: Displays the current
Cartridge Type assigned to the assay based
on the Cartridge Lot # assigned; will be blank
until Cartridge Lot # entered.

EndoScan-V™ is now ready to run a cartridge using the nexgen-PTS™ instrument. Up to five (5) nexgen-PTS™
instruments can appear in one tab at a time.

4.4.3 ADD NEXGEN-MCS™ INSTRUMENT

Along the bottom of the Instrument Manager window, select the drop-down menu for Add and choose “nexgen-
MCS” to open the Add/Modify Instrument dialog.

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  IP Address – Base IP address of the nexgen-MCS™ instrument; example: 192.168.100.106.
 Description – Enter a description for this instrument; while not required, it’s helpful to add details such as
location or any special numbers or naming conventions assigned to the instrument to make it easier to
identify or recognize quickly.

Select the Add button and the software will connect to the Instrument. Once the connection is complete, the
nexgen Instrument(s) Bay Settings window will appear.

The initial setup of a nexgen-MCS™ assumes you would like to run the instrument in your first tab and that each
brick of the MCS™ should be assigned to panels 1-5 in order. You can change the tab number (up to 3) and the
panel numbers.

If the nexgen-MCS™ is the first and only instrument you are connecting to, you can use the defaults where the
nexgen-MCS™ is in tab 1 and the bays are displayed in panels 1-5 in that tab.

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Select Add, and the instrument configuration will be saved into the database. A notification message will confirm
the Instrument was saved.

The software will then present the Instruments main window with the new nexgen-MCS™ added to the table.

The icon will refresh the instruments connected to EndoScan-V™.

To activate the nexgen-MCS™, check the Active Instrument box, then press Close.

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Once you select Close, the system will activate the instrument, change to Cartridge Mode and display the nexgen-
MCS™ Cartridge Panel for each bay in the dashboard.

In the example above, the nexgen cartridge panel contains the following:

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  Instrument Icon: Displays an icon of the
nexgen-MCS™ instrument.
 Tab and Bay Numbers: Example “2-1” refers
to Tab #2 and Bay #1.
 Instrument Serial Number: Identifies the
instrument.
 Bay Serial Number: Identifies the bay within
the instrument.
 Assay Name: Combination of Assay Prefix
(configured in Global Settings), Bay Serial
Number, Panel Number, Date (in
YYYYMMDD format), Sequence Number (set
on the bay, reset daily, increments with each
new assay), and Assay Suffix (configured in
Global Settings).
 Status Indicator: See nexgen-MCS™
Cartridge Panel Test Sequence for more
information.
 Assay Setup: See nexgen-MCS™ Assay Setup
for more information.
 Assay Results: See nexgen-MCS™ Assay
Result Screen for more information.
 Test Sequence Message: See nexgen-MCS™
Cartridge Panel Test Sequence for more
information.
 Bay IP Address: Identifies the IP address of
the bay within the instrument.
 Cartridge Panel Menu: Opens the Cartridge
Panel Menu where users can download log
files, send commands to the instrument,
download results, etc.
 Cartridge Type: Displays the current
Cartridge Type assigned to the assay based
on the Cartridge Lot # assigned; will be blank
until Cartridge Lot # entered.

EndoScan-V™ is now ready to run a cartridge using the nexgen-MCS™.

4.4.4 DISCOVER NEXGEN INSTRUMENTS

Select Add, then Discover nexgen instruments, and the following window will appear.

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Enter the IP Address and a Range for the software to discover the instrument.

(Example: Base IP: 192.168.1.1 and Range 255, means that EndoScan-V™ will search IP addresses that are in the IP
range of 192.168.1.1 to 192.168.1.255)

For the example above, the Discover function will attempt to find nexgen-MCS™ bays at 192.168.1.101 to
192.168.1.106.

Select Add, and the software will complete a series of steps to connect to the instrument.

The Discover function will display any nexgen instruments that are connected.

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Select the bays for use, then fill in the tab and panel number. If you would like all 5 bays displayed in a single tab,
the tab number for each bay would be 1 and the panel number would be 1 for bay 1, 2 for bay 2, 3 for bay 3, 4 for
bay 4 and 5 for bay 5. Each bay can also be displayed as 5 different tabs. Once all information is completed see
below:

In the Instrument window, activate the instrument you have configured by checking the Activate checkbox.

Select Close, and the software will display the cartridge panels for the activated instrument. You need to log out
and log back in when you activate an instrument.

The software is now ready to run an assay.

4.4.5 ADD ELX808™ INSTRUMENT

Before you get started, make sure the instrument is powered on and the data cable is connected between the
instrument and the workstation. The steps in this section pick up where the How to Add An Instrument section left
off; if you haven’t already, return and complete the steps in that section before continuing with these instructions.

Along the bottom of the Instrument Manager window, select the drop-down menu for Add and choose “BioTek
ELx808” to open the Add/Modify Instrument dialog.

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In the Add/Modify Instrument dialog, enter the following details:

 COM Port: Enter the COM port currently assigned to the instrument; if you’re not sure which one is
assigned, open Windows Device Manager and look under “Ports”.
 Serial Number: Enter the serial number for the instrument; the serial number should be printed on the
instrument label, typically on the back or side of the instrument.
 Tab Order: If you plan on connecting multiple ELx808™ instruments with the same workstation, enter the
Tab Order for this instrument. The Tab Order determines the order in which the tab for each instrument of
the same type will display in the dashboard; each instrument must be assigned a unique Tab Order number

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 to avoid a situation in which two (2) instruments with the same Tab Order value are attempt to connect at
the same time.
 Description: Enter a description for this instrument; while not required, it’s helpful to add details such as
location or any special numbers or naming conventions assigned to the instrument to make it easier to
identify or recognize quickly.

NOTE: If you are not sure

which COM port the
instrument is currently
assigned to, open
Windows Device
Manager and look under
“Ports”.

In this example, the PRS

instrument is currently
using “COM8”.

From here, users may choose between four (4) options:

 Test Connection: The system will attempt to establish a line of communication with the instrument. Users
will receive a popup message advising if the connection was successful or if the connection failed and could
not be established.
 Self-Test Report: [See Self-Test Report For Elx808IU™ And PRS Instruments for more details.]
 Add: Add the instrument to the system database; the system will serve the user with a confirmation
message that the instrument was added successfully.
 Close: Cancel the current operation, discard the details, and return to the Instrument Manager dialog.

ACTIVATE OR DEACTIVATE AN INSTRUMENT

Once the instrument is added to the system, users will see a line item for the new instrument in the Instrument
Manager dialog.

From here, users can mark the instrument as Active or Inactive which will assign the instrument to or unassign the
instrument from the workstation. The system will use the current instrument assignment to determine which
dashboard mode to display to the user (see Navigating the Software for more details on dashboard modes).

To toggle the instrument’s assignment, open the Instrument Manager window (Settings in the main menu and
then choose Instruments) and find the row for the instrument. In the Active column:

 Check the box to mark the instrument as active for this workstation.
 Clear the box to mark the instrument as inactive for this workstation.
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Select Close to submit the change and return to the dashboard; the system will update the dashboard display to a
new mode based on the active (or inactive) status of the known instrument(s).

In the above example, the system is in Microplate mode for an ELx808™ instrument with all optional Layout windows
displayed. Your dashboard may look different if you have a different instrument or alternate Layout windows selected.

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For more information on the main menu options in microplate mode, see Navigating the Software. For more
information on the instrument dashboard or assay configuration, see Setting Up and Running a Microplate Assay.

4.4.6 ADD PRS INSTRUMENT

Before you get started, make sure the instrument is powered on and the data cable is connected between the
instrument and the workstation. The steps in this section pick up where the How to Add An Instrument section left
off; if you haven’t already, return and complete the steps in that section before continuing with these instructions.

Along the bottom of the Instrument Manager window, select the drop-down menu for Add and choose “PRS” to
open the Add/Modify Instrument dialog.

In the Add/Modify Instrument dialog, enter the following details:

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  COM Port: Enter the COM port currently assigned to the instrument; If you’re not sure which one is
assigned, open Windows Device Manager and look under “Ports”.
 Serial Number: Confirm the Serial Number populated by the system automatically is correct; the serial
number should be printed on the instrument label, typically on the back or side of the instrument.
 Tab Order: If you plan on connecting multiple PRS instruments with the same workstation, enter the Tab
Order for this instrument. The Tab Order determines the order in which the tab for each instrument of the
same type will display in the dashboard; each instrument must be assigned a unique Tab Order number to
avoid a situation in which two (2) instruments with the same Tab Order value are attempt to connect at the
same time.
 Description: Enter a description for this instrument; while not required, it’s helpful to add details such as
location or any special numbers or naming conventions assigned to the instrument to make it easier to
identify or recognize quickly.

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 NOTE: If you are not sure
which COM port the
instrument is currently
assigned to, open
Windows Device
Manager and look under
“Ports”.

In this example, the PRS

instrument is currently
using “COM10”.

From here, users may choose between four (4) options:

 Test Connection: The system will attempt to establish a line of communication with the instrument. Users
will receive a popup message advising if the connection was successful or if the connection failed and could
not be established.
 Self-Test Report: [See Self-Test Report For Elx808IU™ And PRS Instruments for more details.]
 Add: Add the instrument to the system database; the system will serve the user with a confirmation
message that the instrument was added successfully.
 Close: Cancel the current operation, discard the details, and return to the Instrument Manager dialog.

ACTIVATE OR DEACTIVATE AN INSTRUMENT

Once the instrument is added to the system, users will see a line item for the new instrument in the Instrument
Manager dialog.

From here, users can mark the instrument as Active or Inactive which will assign the instrument to or unassign the
instrument from the workstation. The system will use the current instrument assignment to determine which
dashboard mode to display to the user (see Navigating the Software for more details on dashboard modes).

To toggle the instrument’s assignment, open the Instrument Manager window (Settings in the main menu and
then choose Instruments) and find the row for the instrument. In the Active column:

 Check the box to mark the instrument as active for this workstation.
 Clear the box to mark the instrument as inactive for this workstation.

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Select Close to submit the change and return to the dashboard; the system will update the dashboard display to a
new mode based on the active (or inactive) status of the known instrument(s).

In the above example, the system is in Microplate mode for a PRS instrument with all optional Layout windows displayed.
Your dashboard may look different if you have a different instrument or alternate Layout windows selected.

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For more information on the main menu options in microplate mode, see Navigating the Software. For more
information on the instrument dashboard or assay configuration, see Setting Up and Running a Microplate Assay.

4.4.7 SELF-TEST REPORT FOR ELX808IU™ AND PRS INSTRUMENTS

BioTek® ELx808IU™ and Endosafe® PRS instruments have a special Self-Test function. The Self-Test initiates a set of
testing procedures meant to confirm the instrument is working as expected then download a report of the self-test
results for users to review.

Users initiate the Self-Test from the Add/Modify Instrument dialog, found in the Instrument Manager by navigating
to Settings from the main menu, then Instruments to open the Instrument Manager dialog.

 To perform a self-test just before adding a new instrument to the system, follow the steps from Adding an
ELx808™ Instrument or Adding a PRS Instrument then, before choosing “Add” as the last step to save the
instrument to the system, select Self-Test Report.
 To perform a self-test for an existing instrument, select the target instrument in the instrument table and
choose Modify which will open the Add/Modify Instrument dialog where you will find the Self-Test Report
option to select.

You may notice some slight differences between the display of ELx808™ and PRS instruments in the Add/Modify
Instrument dialog however both instruments follow the same steps to initiate the Self-Test:

Add/Modify Instrument dialog for ELx808™ Add/Modify Instrument dialog for PRS

STEPS

 Open the Add/Modify Instrument dialog by navigating to Settings in the main menu, then choose
Instruments. In the Instrument Manager dialog, select to highlight an existing instrument and choose
Modify from the bottom of the window.

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  In the Add/Modify Instrument dialog, choose Self-Test Report. Once you select the option, the system will
send the request to initiate the self-test to the instrument; users may hear instrument movements or noises
as it cycles through the self-test procedures.

 When the self-test is complete, the system will download a copy of the Self-Test Report document with the
results from the test and serve the user with a confirmation message. In the confirmation message, the
download location of the Self-Test Report is provided.
 Select OK to confirm and return to the Add/Modify Instrument dialog.

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The report is generated in .PDF format; the default file location used by the system to save the file and the default
file name format is as follows:

C:/ProgramData/Charles River/EndoScan-V/Documents/[MMDDYYYY]

[Instrument Name] Self-Test Report-[YYYY-MM-DD-HHMMSS].pdf

Examples: “BioTek ELx808 Self-Test Report-2023-06-01-132501.pdf” or “PRS Self-Test Report-2023-07-31-

103120.pdf”

The Self-Test runs diagnostics of the instrument and diagnoses any failures. Refer to the relevant instrument
manual(s) for additional details on the System Self-Test functionality.

4.4.8 ADD NEXUS 200™ INSTRUMENT

Please refer to the Nexus 200 User Manual for details on this procedure.

4.5 Global Settings

The Global Settings dialog is used to configure system-wide or global functionality including some instrument
specific settings.

Global Settings is found in the main menu under Settings then Global Settings. The Global Settings dialog is divided
into six (6) tabs for different configuration topics: General, Security, Report, Microplate, Cartridge, and Nexus 200.

Note: The Nexus 200 tab will only display if your system has been configured for the Nexus 200™ instrument; for all
other configurations, this section is hidden and not displayed.

4.5.1 GENERAL TAB

The General tab covers general assay settings, validation terminology, and sample limit value terminology.

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See the below tables and supporting descriptions for additional details for each field such as type, default value,
valid range, and a brief review of what the setting controls.

GENERAL ASSAY SETTINGS

Label Field Type Default Value Valid Range Details

Export File Path Fill in field from C:\ProgramData\Charles Any valid folder Used to set an export
Browse selection. River\EndoScan-V™\Export accessible by the PC file path for exports.
Assay Name Text input CRL 1-10 characters Used to add a prefix to
Prefix the assay name.
Assay Name Text input Blank 1-10 characters Used to add a suffix to
Suffix the assay name.
Auto Export Check box with 2 Checked, CSV Checked/unchecked. Used if automatic
radio buttons (CSV If checked CSV is the exports are required.
and XML) default Will export file as soon
as assay completes.
Spike Recovery Whole number input 50 0-500 Lower Limit for Spike
Range lower Recovery, current
limit regulations state 50%.
See below for further
information.

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 Label Field Type Default Value Valid Range Details
Spike Recovery Whole number input 200 0-500 (upper limit Upper Limit for Spike
Range upper must be larger than Recovery, current
limit the lower limit) regulations state 200%.
See below for further
information.
Include Check box Unchecked Checked/unchecked Includes column
Headers in CSV headers in a CSV export.
Auto Print Check box Unchecked Checked/unchecked Will automatically print
a report once the assay
is complete.
Allow Expired Check box Unchecked Checked/unchecked If checked, this will
Accessories allow users to use
expired accessories
from the accessory
database.
Require Check box Unchecked Checked/unchecked See 0 below table.
Comment for
Global Settings
Require Check box Unchecked Checked/unchecked See 0 below table.
Comments for
Post Assay
Changes
Require Check box Unchecked Checked/unchecked See 0 below table.
Comment on
Signature
Cancellation

Spike Recovery Range

EndoScan-V™ calculates spike recovery as a percentage for wells containing spiked samples. The range entered into
the field, in percent, is the acceptable range for spike recovery and will be included on reports.

Require Comments

Three checkboxes are available for Global Settings, Post Assay Changes, and Signature Cancellation. If these boxes
are checked, should any authorized user attempt to make changes to Global Settings, make changes to assays once
complete, or Cancel a Digital Signature they will be forced to write a comment.

Comments must be a minimum of one (1) character in length. The comment will appear on the Audit Trail line item
associated with the activity, providing the ‘WHY’ to critical Audit Trail activities.

For example:

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VALIDATION TERMINOLOGY:

Field Label Field Type Default Value Valid Range Information

VALID Pull down menu VALID VALID, PASS Provides the

nomenclature on the
report when a result
is Valid.

INVALID Pull down menu INVALID INVALID, FAIL Provides the

nomenclature on the
report when a result
is Invalid.
UNDEFINED Pull down menu UNDEFINED UNDEFINED, Provides the
UNDETERMINED, nomenclature on the
UNKNOWN, report when a result
UNRESOLVED is Undefined.

SAMPLE LIMIT VALIDATION TERMINOLOGY:

Field Label Field Type Default Value Valid Range Information

Sample Valid Pull down menu VALID VALID, PASS Provides the
nomenclature on the
report when a
Sample Limit result is
Valid.

Sample Invalid Pull down menu INVALID INVALID, FAIL Provides the
nomenclature on the
report when a
Sample Limit result is
Invalid.
Sample Undefined Pull down menu UNDEFINED UNDEFINED, Provides the
UNDETERMINED, nomenclature on the
UNKNOWN, report when a
UNRESOLVED Sample Limit result is
Undefined.

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4.5.2 SECURITY TAB

PASSWORD SECURITY:
Field Label Field Type Default Value Valid Range Definition Information
Password Number input 90 0-365 How many days 0 will turn off
Timeout-Days before a user security features.
password expires.
Password History Number input 5 0-10 How many 0 will turn off
previously used security features.
passwords are
checked when
creating a new
password.
Login Timeout - Number input 15 0-180 How many 0 will turn off
Minutes minutes before a security features
user is locked out
after inactivity.
Password Pull down menu 3 0-10 How many 0 will turn off
Attempts attempts before a security features
user is locked out.

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 Field Label Field Type Default Value Valid Range Definition Information
Password Pull down menu 14 0-14 How many days 0 will turn off
Warning-Days before a security features
password
expiration
warning message
appears.

SERVER BACKUP DETAILS SECTION:

Field Label Field Type Default Value Valid Range Information
Backups Enabled Pull down menu No Yes/No Allows user to enable
or disable backup of
database.
Backup Interval-Days Pull down menu 1 1-365 days Allows user to choose
the backup interval.
Prefix Text input Blank 0-10 characters Allows the user to
choose a prefix to the
backup file name.
Next Backup Date and time stamp Read from database Must be in the future Provides the user the
information of when
the next backup is
scheduled.
Backup Destination File path c:\ProgramData\Charl Any available Allows the user to
esRiver\EndoScan- directory on PC choose the backup
V™\Database\Backup\ destination file path.

4.5.3 REPORT TAB

Allows the user to establish settings for the reports.

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REPORT SETTINGS:

Field Label Field Type Default Value Valid Range Information

Report Logo File display CRL logo See Information column The Report Logo
function can accept
.JPEG, .JPG, and .PNG
images. The report
header section for the
logo is 213 by 55
pixels. Any logo with
this approximate ratio
will load into the
software correctly
and with no
distortion. The default
CRL logo is 300 DPI.
Any logo with this DPI
or higher will render
accurately.
Logo position Pull down menu Left Left, Center, Right Allows the user to
choose the position of
the logo on printed
reports

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 Field Label Field Type Default Value Valid Range Information
Lab Name Text input Blank Text up to 40 characters Allows the user to
choose the Lab Name
to be displayed on the
reports
For Invalid Assay Checkbox Unchecked Unchecked/checked Allows the user to
Show N/A for choose if the Sample
Sample Value Value should be
displayed on a report
if other parameters
are invalid.
Add Disclaimer to Checkbox Unchecked Unchecked/checked Allows the user to
All Summary choose if a Disclaimer
Reports should be added at
the bottom of all
summary reports.
Show Accessories Checkbox Checked Unchecked/checked Allows the user to
in Report choose if the list of
Accessories used in an
assay should be
printed on the report.
Disclaimer Text input N/A 0-300 characters Allows the user to
type a Disclaimer to
print on the summary
reports if the ‘Add
Disclaimer to All
Summary Reports’ is
checked.
4.5.4 MICROPLATE TAB

Allows a user to establish certain parameters for a microplate assay.

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MICROPLATE LAYOUT SETTINGS:

Field Label Field Type Default Valid Range Information

Value
Number of Pull down 2 1-96 Allows the user to choose the number of replicates
Replicates menu to be displayed on the assay. Can be edited at the
assay level. Continue reading for more details.
SPL color Color swatch - Blue Any color Allows the user to choose the text color for Samples
brings up that will appear in the assay grid. Continue reading
color palette for more details.
SPK color Color swatch - Purple Any color Allows the user to choose the text color for Spikes
brings up (Positive Product Controls) that will appear in the
color palette assay grid. Continue reading for more details.
STD color Color swatch - Black Any color Allows the user to choose the text color for
brings up Standards that will appear in the assay grid.
color palette Continue reading for more details.
CTRL color Color swatch - Green Any color Allows the user to choose the text color for the
brings up Negative Control the assay grid. Continue reading
color palette for more details.
Reaction Time Pull down SSSS SSSS or Allows the user to choose the reaction time format.
Format menu HH:MM:SS Continue reading for more details.
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 Field Label Field Type Default Valid Range Information
Value
Replication Pull down Left to Right Left to Right Allows the user to choose the replication direction.
Direction menu or Top to Continue reading for more details.
Bottom
Wells Masked Text field Blank 0-40 Allows the user to mask wells. Continue reading for
characters more details.
Auto Stop Checkbox Unchecked Unchecked or Allows the user to select auto stop for all assays.
checked Auto stop completes the assay once lambda has
reacted.
Automatic Checkbox Unchecked Unchecked or Allows the user to choose automatic creation of
Creation of checked spikes (positive product controls). Spikes will then
Spikes be created for every sample added to the assay grid.
Continue reading for more details.

Number of Replicates

The number of times a sample, spike, standard, or control is automatically duplicated when entered onto the grid
during setup. The default number of replicates is 2.

Colors (SPL Color, SPK Color, STD Color, CTRL Color)

Colors may be defined for the text on the well grid for categories of groups (STD,
CTRL, SPL, SPK) using the Colors button on the Microplate Layout Settings tab.

Clicking on the color box for each category presents a dialog box.

Pick the desired color and select OK.

Reaction Time Format

The format in which the time values are entered and reported. The possible time formats are: SSSS (integer
seconds) or HH:MM:SS (where HH:MM:SS is the time relative to the start of collection). Select the desired time
format from the drop-down menu. The default time format is SSSS.

Replication Direction

The direction for automatic replication can be set for either left to right or top to bottom. Left to right replication
enters the first sample, standard, or control in a column and the replicate is entered in the next column(s) to the
right until the number of replicates is reached. Top to bottom replication enters the first sample, standard, or
control in a row and the replicate is entered in the row(s) immediately beneath until the number of replicates is
reached. If automatic spike creation is selected the spikes will be replicated in the same direction as the sample.
The default replication direction is left to right.

Wells Masked

Data in wells can be masked, or hidden, from use in calculations and reports. Any wells listed in the Wells Masked
box are masked for a new assay opened in EndoScan-V™. Enter the wells to be masked by typing the well reference
(the letter number combination, such as A3 or G10) separated by a comma (,).
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Automatic Creation of Spikes

The Automatic Creation of Spikes option directs the software to enter spike information for each sample entered
onto the grid. When Automatic Creation of Spikes is selected, spike values will be placed in the same number of
wells as the sample and its replicates when a sample is added to the grid. When Automatic Creation of Spikes is not
selected, only samples in the samples database with the auto spike value of “yes” will have spikes created when
placed on the grid. The value of the spike is controlled by the spike concentration information in the sample
database.

The Auto Spike value of any sample added from the Sample database will override the global Automatic Creation of
Spikes. For example: If the global Automatic Creation of Spikes is set to False and the Auto Spike of a sample in the
Sample Database is set to True then the sample, when added to the grid, will also add the spike wells.

MICROPLATE CALCULATIONS:

Field Label Field Type Default Value Valid Range Information

Regression Pull down menu Linear Linear or Polynomial Allows the user to choose
the regression type for
analysis. Continue reading
for more details.
Default Pull down menu Kinetic Turbidimetric Endpoint, Kinetic Allows the user to choose
Collection Type Turbidimetric or the default collection type
Kinetic Chromogenic for all assays (can be edited
at the assay level).
Polynomial Pull down menu 4 2,3,4 Allows the user to choose
Order the polynomial order if
Polynomial Regression is
being used. Continue reading
for more details.

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 Field Label Field Type Default Value Valid Range Information
# of Points to Pull down menu 3 2,3,4 This is used for the Kinetic
Use for MaxV Noise Test in the
Performance Qualification
only. Continue reading for
more details.
Onset OD Number input up to 3 0.1 0-4 Allows the user to choose
decimal places the Optical Onset OD for the
assay. Continue reading for
more details.
# of Decimals Number input 4 1-5 Allows the user to choose
to Display for the numbers of decimals to
Endotoxin display for Endotoxin Value.
Value
CV Limit- Number input up to 3 10% 0-100% Allows the user to choose
Samples decimal places the Coefficient of Variation
for the Samples. Continue
reading for more details.
CV Limit- Number input up to 3 10% 0-100% Allows the user to choose
Standards decimal places the Coefficient of Variation
for the Standards. Continue
reading for more details.
Default Spike Number input up to 0.5 0-99999 Allows the user to choose
Concentration five (5) decimal places the default spike
concentration for assays. Can
also be set in Sample
Database for each sample.
Continue reading for more
details.
Enable Check box Checked Checked/unchecked Allows the user to enable
Validation any validation criteria chosen
for the assay.
Average Check box Checked Checked/unchecked Allows the user to choose
Replicates Average Replicates.
Inline Spiking Check box Checked Checked/unchecked Allows the user to choose
Inline Spiking. Continue
reading for more details.
Show CV Prefix Check box Unchecked Checked/unchecked Allows the user to show the
Coefficient of Variation
prefix.
Spike Recovery Check box Unchecked Checked/unchecked Allows the user to choose.
for Unreacted Continue reading for more
Samples – Use details.
Zero

Regression
EndoScan-V™ can perform either Linear or Polynomial regression to analyze the standard curve. The linear
regression option is the default selection for new microplate assays. Select the default type of regression desired. If
Polynomial regression is selected, the Polynomial Order list box will be enabled.

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Polynomial Order
EndoScan-V™ can perform Polynomial regression of order, or degree, 2, 3, and 4. Select the default order of
polynomial regression.

Note: For Polynomial Regression to be performed there must be one (1) more data point than the defined
Polynomial Order. If the selected degree of polynomial regression cannot be performed due to an inadequate
number of standards or points, linear regression will be used to determine the standard curve.

# (Number) of Points to Use for MaxV

The default number of data points used to calculate the maximum slope or MaxV. Possible options for the number
of data points are 2, 3, or 4. This function is used for Performance Qualification only.

Onset OD
The Onset OD option is the default optical density (OD) reaction-time threshold.

CV Limit – Samples
EndoScan-V™ calculates the coefficient of variation (CV) of the well results for each sample and spike. The limit
entered into this field, in percent, is the default acceptable limit for sample and spike CV for the limit set.

CV Limit – Standards
EndoScan-V™ calculates the coefficient of variation (CV) of the well results for each standard. The limit entered into
this field, in percent, is the default acceptable limit for each standard CV for the limit set.

Default Spike Concentration

The default concentration in endotoxin units for automatically created spikes. Any logical concentration may be
entered in this box. The units are designated by the units entered on the Assay Properties. The default
concentration is 0.5.

Enable Validation
Selecting this option directs the program to evaluate the group criteria for the assay and to determine the validity
of the criteria. The status of the criteria is reported using the Validation Terminology selected.

Average Replicates
Average Replicates determines how the data is used in regression and endotoxin calculations. When this option is
selected, the program averages the data from all the replicates prior to performing the calculations. When this
option is not selected the individual optical density (OD) data values are used in the regression and endotoxin
calculations.

Inline Spiking
Sample spikes may be placed in the same row or column as the sample or in an adjacent row or column. When the
Inline Spiking Option is on, the sample spikes are placed in the same row or column as the sample (depending on
replicate direction). If Inline Spiking is off, the sample spikes are placed in the next adjacent row or column
(depending on replicate direction).

Spike Recovery Calculation for Unreacted Samples – Use Zero

For unreacted samples, EndoScan-V™ calculates spike recovery using the smallest standard EU or zero, depending
on this option. The default is to use the smallest standard EU.

4.5.5 CARTRIDGE TAB

Allows a user to establish certain parameters for a cartridge assay.

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CV Limit – Cartridges

The cartridge reader calculates the coefficient of variation (CV) of the channel results for the sample and spike. The
limit entered into this field, in percent, is the acceptable limit for sample and spike CV. The default is set to 25% as
per the product insert for cartridges.

Display Sample Value by Channel

For cartridge instrument assays, sample endotoxin results can be displayed and reported for each sample channel
or for the average reaction time of both sample channels. Default is off.

Nexgen Software Settings

This section allows the user to enable or disable settings on the nexgen PTS or MCS software. These settings can
only be used with nexgen 11 (or higher).

 Halt on No Sample - Draw: If this is enabled, the software will immediately stop the assay if sample is not
detected upon drawing into the instrument. If unchecked, this feature is not enabled.
 Sample Size Detection: If this is enabled, the software will detect whether too much or too little sample was
dispensed in each well. This feature must be enabled if Halt on Sample Size Error is desired to be enabled. If
the box is unchecked, this feature is not enabled.

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  Halt on Sample Size Error: If this feature is enabled, the software will stop the assay if a sample size error is
detected, as in too much or too little sample was added. Sample Size Detection must be enabled to use this
feature. If the box is unchecked, this feature is not enabled.
 Detect Early Sample in Optical Well: If this feature is enabled, the software will alert the user if sample is
detected too early in the Optical Well. This can be an indication of thin cartridge channel, or seal or pump
issue. If this error is enabled and continues to be flagged, contact Endosafe-Support@crl.com as the
instrument may require servicing.
 Halt on Early Sample in Optical Well: Prior to enabling this feature the Detect Early Sample in Optical Well
must be enabled. If this feature is enabled, the software will stop the assay if sample is detected too early in
the Optical Well.
 Halt on No Sample – Optical Well: If this feature is enabled, the software will stop the assay if no sample is
detected in the optical well.
 Generate Report for Aborted/Halted Tests: If this feature is enabled, a report will be generated for all
aborted or halted tests. If this is not enabled, a test report will not be generated for a test that has been
aborted or halted, but the error will be recorded in the Audit Trail.
 Assay Minimum Sample Size: A user with appropriate permissions can set the minimum sample size that
the software will detect.
 Assay Maximum Sample Size: A user with appropriate permissions can set the maximum sample size that
the software will detect.
4.5.6 NEXUS 200 TAB
Please refer to the Nexus 200 User Manual for details on these global settings.

4.6 Digital Signature Configuration

To use the Digital Signature feature to digitally sign assay reports, administrators must configure Digital Signature
Roles. Roles are configured by navigating to Settings in the main menu and then selecting Digital Signature
Configuration from the drop-down.

For more information on applying Digital Signatures to reports, see Reports & Digital Signatures.

Note: Be sure to assign the user who will configure Digital Signature Roles the “Digital Signature Configuration”
privilege; otherwise, the Digital Signature Configuration option in the Settings menu will be hidden.

There are three (3) Digital Signature Role Levels: Level 1 (L1), Level 2 (L2), and Level 3 (L3). Each level represents a
separate layer of review and a separate signature which may be added to a report. Not all levels must be used but
no new or additional levels may be added; three (3) levels are the limit.

There are three (3) Digital Signature Role Names: Analyst, Reviewer, Quality Control. The Role Name is linked with
the Role Level; Analyst is linked with the L1 level, Reviewer with the L2 level, and Quality Control with the L3 level.
While administrators may not change this linkage, they may change the Role Names themselves.

Finally, each Digital Signature Role (Name and Level) must be assigned at least one (1) Signature Meaning but may
assign multiple meanings. When users walk through the process of digitally signing reports, the system will prompt
them to select a Signature Meaning.
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Both the Digital Signature Role and Signature Meaning will be added to the report when signing and will display on
the reports.

CHANGE THE DIGITAL SIGNATURE ROLE NAME

Open the Digital Signature Configuration dialog by selecting Settings from the main menu and choosing Digital
Signature Configuration.

Select the Role Name to change and key in the new name. When finished, select Close at the bottom of the dialog
to return to the dashboard; changes are saved as you enter them.

ADD SIGNATURE MEANING TO DIGITAL SIGNATURE ROLE

Open the Digital Signature Configuration dialog by selecting Settings from the main menu and choosing Digital
Signature Configuration.

Select the Role Name and in the Signature Meaning field enter the text to display explaining the purpose of the
signature. Choose Add to submit; multiple Signature Meanings may be added to each Role for flexibility.

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DELETE DIGITAL SIGNATURE MEANING

To delete a digital signature meaning, select to highlight the meaning to be removed then choose Delete.

4.7 Manage Locks

Manage locks works for those customers using numerous installs but working on the same central database.

On occasion, an authorized user may have to unlock a record within the system. For example, a record may have
been locked by a user who has been deleted by the system, or who has left the company or whose computer may
have crashed.

The Manage Locks function is in the Settings menu.

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 Column Name Description
Lock The object that has been locked. It could be an Assay name, template name, or Global
Settings.
Lock Type There are 4 different lock types - Cartridge Assay, Microplate Assay, Template (microplate
only), or Settings.
PC Name The PC name of user that owns the lock.
Login Name The Login of the user that owns the lock.
Last Accessed The timestamp of the creation of the lock.

Once the record is unlocked, other users may access it. Any changes to the record made by the user whose lock
was unlocked may or may not (be) saved. Unlocking should only be used when there is no other way to access the
record.

The software will allow only one user at a time to modify a record in the database. This feature eliminates the
possibility of two users attempting to modify a record at the same time. This feature is applicable for certain
records in Global Settings, Assays, Templates, and User Management.

Global Settings
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If two or more users attempt to access Global Settings at the same time, the first user to access the specific setting
screen will gain access, or ‘win’, the ability to edit. The next user(s) who attempt to access the same screen to edit
will get a notification (as below) which states that the Global Settings is locked by the first user, and to try again
later.

Results Database – Microplate Mode

If two users attempt to access Assay/Results at the same time, the first user will ‘win’ the ability to edit. The next
user(s) will get a notification screen (as below) which states that the Assay is locked by the first user.

Results Database – Cartridge Mode

If two users attempt to access a Cartridge Assay/Result at the same time, the first user will ‘win’ the ability to edit.
The next user(s) will get a notification screen (as below) which states that the Assay is locked by the first user.

Accessing a Template

If two users attempt to access a Template at the same time, the first user will ‘win’ the ability to edit. The next
user(s) will get a notification screen (as below) which states that the Template is locked by the first user.

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5 RESULTS

Selecting Results will open the Assay Explorer where users may review assay results. Depending on which mode
the user is currently in, the user will be presented with either the Microplate Results or Cartridge Results window.

For Nexus 200, results are obtained through the Cartridge Results window, which is detailed in the Nexus 200 User
Manual.

5.1 Results – Microplate Mode

Fields available in Results window in Microplate Mode:

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 Field Label Field Type Default Value Valid Range Mandatory Information
From Date Date Yesterday’s date Any date in the No A search field
past used to find a
particular Assay
date range.
To Date Date Tomorrow’s date Any date in the No A search field
past used to find a
particular Assay
date range.
Assay Name Text Blank N/A No A search field
used to find a
particular Assay
name.
Search Keyword Text Blank N/A No A search field
used to find a
particular string
in the table.
All Results Radio button All results One of the 4 Yes Will display both
(toggles) Completed
Assays and
imported .pltx
files in the table
when selected.
Completed Radio button All results One of the 4 Yes Will display
Assays (toggles) Completed
Assays in the
table when
selected.
Imported PLTX Radio button All results One of the 4 Yes Will display
files (toggles) imported .pltx
files in the table
when selected.
Templates Radio button All results One of the 4 Yes Will display
(toggles) Template files in
the table when
selected.

Column Fields in Results Window:

Table Column Label Definition Information

Assay Name Assay Name Unique identifier
Created By Who the assay was created by Details the user’s full name
Test Date/Time Assay Date/Time N/A
Collection Type Collection Type Kinetic Turbidimetric, Kinetic
Chromogenic, End Point
Assay Type Assay Type LAL or rCR
Instrument Serial Number Instrument Serial Number N/A

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 Table Column Label Definition Information
Signature Level If signed, at what level? Blank, Analyst, Reviewer, or QC
Auto Export Was the assay exported? Displays Yes or No.
Imported Is the file an imported one? Displays Yes or No.
Signature Status Digital Signature Status Signed or Unsigned

A user can search the table by date, Assay Name, keyword or by hovering over the column header they would like
to search on. When the mouse hovers over the column header, the search arrow appears to the right of the
column header if the field is searchable – see below:

A search column window appears. A user can select the values needed by clicking the check boxes. The window
also allows the user to type in a specific value (Text Filter). To apply the search criteria select Apply.

5.2 Results – Cartridge Mode

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Fields available in Results Window:

Field Label Field Type Default Value Valid Range Definition

From Date Date Yesterday’s date Any date in the past A search field used to find a particular
Assay date range.
To Date Date Tomorrow’s date Any date in the past A search field used to find a particular
Assay date range.
Assay Name Text Blank N/A A search field used to find a particular
Assay name.
Search Text Blank N/A A search field used to find a particular
Keyword string in the Assays.
All Results Radio button All results One of the 4 Will display both completed assays and
(toggles) imported .pltx files in the table when
selected.
Completed Radio button All results One of the 4 Will display Completed Assays in the
Assays (toggles) table when selected.
Imported Radio button All results One of the 4 Will display imported .pltx files in the
PLTX files (toggles) table when selected.
Show Radio button All results Adds 4 additional Shows: Run Start Date Run Number
Automation (toggles) columns on results Sample Position Nexus 200 Serial
Columns screen data Number
(Nexus 200
only)

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 Field Label Field Type Default Value Valid Range Definition
Print Button N/A N/A To print preview reports, digital
signatures can be applied from in the
print preview window.

Column Fields in Results Window (with Show Automation Columns checked):

Table Column Label Definition Comments

Assay Name Assay Name Unique Identifier
Created By Who the assay was created by N/A
Test Date/Time Assay Date/Time N/A
Cartridge Type IE, LAL Cartridge, Glucan Cartridge,
LAL Cartridge, rCR Cartridge
Sample Name Sample Name N/A
Lot Number Sample Lot Number N/A
Run Start Date (Nexus 200 only) Start Date of Automation Run N/A
Run Number (Nexus 200 only) Each assay ran in one day will be given N/A
a subsequent assay number.
Sample Position (Nexus 200 only) Can be from Racks A-F and position N/A
01-20
Instrument Serial Instrument Serial Number N/A
Number
Nexus Serial Number (Nexus 200 only) Nexus Serial Number N/A
Signature Level If signed, at what level? Blank, Analyst,
Reviewer, or QC
Auto Export Was the assay exported? Yes or No
Imported Is the file imported Yes or No
Signature Status Digital Signature Status Signed or Unsigned

5.3 Results Options

Selecting Multiple Assays

A user can select more than one assay to preview by holding down the shift key and selecting each record.

A user can search the table using the date, assay name, and keyword or by hovering over the column header they
would like to search on. When the mouse hovers over the column header, the search arrow appears to the right of
the column header if the field is searchable – see below:

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 A search column window appears. A user can select the values needed by clicking the checkboxes. The window also
allows the user to type in a specific value (Text Filter). To apply the search criteria select Apply.

The user can highlight one or multiple rows. First click on Preview to preview all the results and then print.

Digital Signature Flow for Cartridge Results

The user can highlight one or multiple rows to select data for digital signature. Click on preview to preview all the
results. The user can then apply digital signatures from within the print preview. To apply the digital signature, the
user must ensure they choose multiples that are at the same signature level. For further information on applying
digital signatures please see Reports & Digital Signatures.

6 REPORTS & DIGITAL SIGNATURES

Reports are available for both Microplate and Cartridge results. Digital Signatures can be applied to records and
this digital signature will print on the report. Manual Signatures can also be used.

Note: If Auto-print is selected the assay will print immediately as the assay completes, before any review or digital
signatures are applied. If utilizing Digital Signatures, it is recommended to not use Auto-Print.

6.1 Microplate Reports

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To view an assay report, first select the Results database icon and locate the desired assay; double click to open
the assay in a tab on the Dashboard. With the assay open, select Reports from the main menu to open the Reports
window.

The report title appears at the top; this can be edited for the report, but it will not edit the assay name in the
Results Database.

Report Type

 Detailed Report: Provides the full details of all the data from the assay.
 Endotoxin Summary Report: Provides a summary of the detailed report. If Disclaimer for Summary Reports
has been chosen (Refer to 0), this will print on the bottom of all summary report.
 Kinetic Noise Report: Provides a specific printout when a Kinetic Noise Test is run (for Performance
Qualification only).
 Report Footer: A user can choose to have Signature on all pages or Signature on last page only. This applies
for manual signature boxes only. If using Digital Signatures, once applied these will appear on each page of
the report.
 Report Comments: This allows the user to add specific comments for the individual report.
 Samples: This allows the user to choose which samples to display on the report.
 Preview: Once Preview is chosen the software will display the preview of the report as follows:

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For Microplate Reports:

 If the Sample CV limit status, Spike CV limit status, R-Value, or Spike Recovery Range status are N/A, the
Endotoxin Limit Status will always be N/A.
 EU Criteria can only be set to < or ≤ when using the Sample database. If typing into the 96 well template
directly then < will be applied as the criteria.
 Each report has a unique Page ID so that pages of a long report can be easily identified. The Page ID is auto
generated and not editable.
 If the Endotoxin Limit has no limit then the Endo Limit status will always be N/A.

At the top of the screen the following options are available:

Print: By clicking on Print, the report will print to a

connected printer. If not using digital signatures the
. report can also be printed and signed manually

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 Save: By clicking on Save, the user will have the option
to save the report to a chosen folder as a PDF.

Digital Signature: By clicking on the Digital Signature

icon a user will be presented with a drop-down menu;
the options to select are Apply Signature and Cancel
Signature.

Choose Digital Signature then Apply Signature:

To digitally sign a record the user must enter their Login Name and Password and click Validate.

Once validated, the Current Validated User field will display the Full Name from the user’s record and the User
Role and Signature Meaning will populate with the appropriate values.

Choose the User Role to use for the signature. Note that signatures work in level order as L1, L2, and L3; for
example, a record cannot be signed at L2 unless it has already been signed at L1. Each level of signature must be
performed by a different user.

Once a user role has been chosen then the Signature Meaning can be chosen from the drop-down menu.

Click Sign Assay to apply the signature; users will be served with a message advising the assay has been digitally
signed with the details.

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Once the digital signature is applied the report will update with the digital signature just above the report footer,
as pictured here:

CANCEL SIGNATURE:

To cancel a Digital Signature which has already been applied to a report, reopen the same report and select Digital
Signature from the toolbar once more.

However, this time choose Cancel Signature.

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When selected, the system will serve the user with a warning message advising the assay has already been signed
and that removing any signature will remove all signatures. Select Yes to confirm or No to cancel and return to the
report preview.

If ‘Require Comments for Cancellation of Digital Signature’ has been checked in Global Settings, the following
dialogue box will appear:

You will be required to type the reason for cancellation before clicking OK. If you do not type comments and
attempt to click OK, you will not be allowed to proceed with the signature cancellation.
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Once OK is selected the following screen will appear:

Click OK to complete the cancelation of the signature.

6.2 Cartridge Reports

From the results screen select the records for signing; multiples can be chosen by utilizing Shift>Up/Down Arrow or
by utilizing Ctrl and clicking on chosen records.

Once records are highlighted click the Print button, which will open the following screen:

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The report title appears at the top; this will detail the assay name if only one assay has been selected from the
Results database. It will remain blank and can be edited if multiple assays have been selected. Changing the report
title will not edit the assay name in the Results Database.

Report Type

Detailed Report: Provides the full details of all the data from the assay.

Endotoxin Summary Report: Provides a summary of the detailed report. If Disclaimer for Summary Reports has
been chosen (Refer to Settings – Section 0), this will print on the bottom of all summary reports. Summary reports
are not available for Gram ID, Glucan, and Inhibition/Enhancement Cartridge types.

Report Footer

A user can choose to have Signatures on all pages or Signatures on the last page only. This applies for manual
signature boxes only. If using Digital Signatures, once applied these will appear on each page of the report.

If multiple reports and “Signature on last page only” are selected, note that for the initial signer, the digital
signature will appear on each page of the last Test Result report. When the next person signs, there will be no
option to pick the type of Report footer, and the Digital Signatures for all signers will appear on all pages.

Report Comments

This allows the user to add specific comments for the individual report.

Preview

Once preview is chosen the software will display the preview of the report as follows:
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At the top of the screen the following options are available:

 For Cartridge Reports: If you print several cartridge reports at a time, the report title will remain blank; you
can type a report title name or leave this blank.
 If Sample CV limit status, Spike CV limit status, or Spike Recovery Range status are N/A, the Endotoxin Limit
Status will always be N/A.
 The EU criteria is displayed to the left of the Endotoxin Limit field.
 EU Criteria can only be set to ≥ or ≤ when using the Sample database.
 Each report has a unique Page ID so that pages of a long report can be easily identified. The Page ID is
auto generated and not editable.
 If the Endotoxin Limit has No limit then the Endo Limit status will always be N/A.
 If cartridge lot number and calibration code are manually typed into the panel, the expiration date for
the cartridge lot number will display as N/A.

Print: By clicking Print, the report will print to a

connected printer. If not using digital signatures the
report can also be printed and signed manually.

Save: By clicking on Save, the user will have the option

to save the report to a chosen folder as a PDF.

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 Digital Signature: By clicking on the Digital Signature
icon a user will be presented with a drop-down menu;
the options to select are Apply Signature and Cancel
Signature.

Apply Signature

To digitally sign a record the user must enter their login name and password and click Validate. Once validated as
having Digital Signature Role access the following screen will appear. This screen will then show the user role levels
the user has rights to.

Choose the User Role to use for the signature.

Note that signatures work in level order as L1, L2, and L3. For example, a record cannot be signed at L2 unless it has
already been signed at L1. Each level of signature must be performed by a different user.

Once a user role has been chosen then the signature meaning can be chosen from the drop-down menu:

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Click Sign Assay to apply the signature. Digital Signature roles and meanings are set up under User Management
and Digital Signature Configuration.

Once the digital signature is applied this will be displayed at the bottom of the report as shown below:

Cancelling a Digital Signature

Cancelling a digital signature involves both the role hierarchy and the Cancel signature privilege.

To illustrate how the hierarchy and privilege works:

In the table below ‘privilege’ refers to the ‘Cancel Digital Signature’ privilege in User Management.

Analyst A – Has the Analyst Digital Signature Role (Level 1)

Analyst B – Has the Analyst Digital Signature Role (Level 1)

Analyst C – Has the Reviewer Digital Signature Role (Level 2)

Analyst D – Has the Reviewer Digital Signature Role (Level 2)

Analyst E – Has the Quality Control Digital Signature Role (Level 3)

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Analyst F – Has the Quality Control Digital Signature Role (Level 3)

Who signed What can What can What can What can What can What can
the Assay? Analyst A Analyst B Analyst C Analyst D Analyst E Analyst F
(L1) do? (L1) do? (L2) do? (L2) do? (L3) do? (L3) do?
Analyst A Analyst A Analyst B Analyst C can Analyst D Analyst E can Analyst F can
only has cannot cannot cancel the can cancel cancel the cancel the
signed the cancel their cancel the signature if the signature signature if signature if
assay. signature signature they have if they have they have they have
unless they even if they the privilege the privilege the privilege the privilege
have the have the assigned. assigned. assigned. assigned.
privilege privilege
assigned. assigned.
Assay is Analyst A Analyst B Analyst C Analyst D Analyst E can Analyst F can
signed by cannot cannot cannot can cancel cancel the cancel the
Analyst B cancel the cancel the cancel the the signature signature if signature if
and Analyst signatures signatures signature if if they have they have they have
D only. even if they even if they they have the privilege the privilege the privilege
have the have the the privilege assigned. assigned. assigned.
privilege privilege assigned.
assigned. assigned.
Assay is Analyst A Analyst B Analyst C Analyst D Analyst E can Analyst F
signed by cannot cannot cannot cannot cancel the cannot
Analyst B, cancel the cancel the cancel the cancel the signature if cancel the
Analyst D, signatures signatures signatures signatures they have signatures
and Analyst even if they even if they even if they even if they the privilege even if they
E. have the have the have the have the assigned. have the
privilege privilege privilege privilege privilege
assigned. assigned. assigned. assigned. assigned.*

*NOTE: This file will be locked, and signatures cannot be cancelled if the Level 3 signatory does not have the cancel
signature privilege. The Cancel Digital Signature Privileges is a suggested privilege in the Admin and Manage
Privilege groups. Charles River recommends that all L3 authorized signatories are provided with the Cancel Digital
Signature Privilege.

When the user chooses to Remove signature while in the Report preview window, they will first get a warning. The
user will then get a confirmation that the digital signature was cancelled.

The Digital Signature History block on the Report will update the new status of the digital signature:

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When cancel signature is chosen in the toolbar, the following pop-up window will appear:

Click Yes to continue with the cancellation of signature.

If ‘Require Comments for Cancellation of Digital Signature’ has been applied in Global Settings, the following
dialogue box will appear:

You will be required to type the reason for cancellation before clicking on Ok. If you do not type comments and
attempt to click Ok, you will not be allowed to proceed with the signature cancellation.

Once Ok is selected the following screen will appear:

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 Click OK to cancel the signature.

Reports General Information

 Failed parameters will highlight in red on the screen when previewing the reports.
 Passed parameters will highlight in green on the screen when previewing the reports.

For more information on Report Logo, Report Disclaimer, etc. please refer to section 0.

7 IMPORT

EndoScan-V™ 6.0 introduced a PostgreSQL database for all data. Data in version 5 of EndoScan-V™ are stored in flat
files with a file extension .pltx. These files can be signed or unsigned. EndoScan-V™ version 6.0 and above will
provide the customer the ability to import these .pltx files from version 5, which contain the .pltx file format of
EndoScan-V™. All files and reports generated are read only. The user will not be able to edit or sign/unsign the
imported files.

.plt files from older versions of EndoScan-V™ can be converted to .pltx files using a converter tool available with
EndoScan-V™ version 6.1 and above; instructions are included in this section.

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7.1 Importing .pltx Files

Selecting a File or Folder to Import

Click Import and the following screen type will appear:

Select Choose PLTX Folder to locate files/folders to be imported. Once the user selects a folder to import from, the
software will check all levels of sub folders for all .pltx files; all identified files in the subfolders will be imported
when the user selects Import.

If the user selects a folder without any .pltx files, it will prompt the user to select a folder that does.

Once the user has selected the files to import, a status bar should appear listing the files being imported. The user
will be given a chance to cancel the import.

If the user imports multiple files, and some do not import, the user will be notified which ones did not import.

7.2 Converting .plt to .pltx Files

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For earlier versions of EndoScan-V™ (versions 1 to 4), .plt files were created by the software. From EndoScan-V™
version 6.1 and above a tool is provided to convert .plt to .pltx files so that the .pltx files may be imported as per
the instructions in section 7.1.

NOTE: EndoScan-V™ software is offered in multiple languages, however, the tool and its screens are only available
in English.

The tool also provides a function to split .pltx. This function allows the user of Charles River’s EndoScan-V™
software version 5.5.5 SP3 to separate cartridge files that contain multiple assays. The separated cartridge .pltx
files will be imported into EndoScan-V™ 6.1 or higher for archiving and printing purposes. If the cartridge file
contains a single cartridge assay, the splitter tool will return the same assay without splitting with the original assay
name and if the .pltx file contains multiple assays, the tool will separate each assay and rename them with 1, 2
along with original assay name (Example: cartridge assay name 123456.pltx is renamed as 123456_1.pltx and
123456_2.pltx etc.).

The application can be located at: “C:\Program Files (x86)\Charles River\EndoScan-V™” and contains two tabs:

 PLT to PLTX Converter.

 PLTX- Cartridge Assay Splitter.

PLT to PLTX Converter

Start the application using the following exe -> EndoScanV.Tools.PltToPltxConverter.exe

The tool will open.

 Choose PLT Folder button: Opens the browse folder window, which contains all the available directories on
the computer allowing the user to select the .plt files from the folder.
 Input Folder Path: Displays the path of the directory that the user selects from the browse folder window.
 Go back button: User can redirect to the previous directory from the current directory.
 Start button: Conversion of .plt to .pltx process starts by clicking on start button.
 Close button: Application will be closed.

Click on Choose PLT Folder button.

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The browse folder window opens allowing the user to select the folder containing the .plt files.

Select the folder that contains the .plt files and press on the OK button.

The tool will show all the available .plt files in the selected folder.

Click on the Start button to convert all the .plt files available in the selected folder.

Note: Users can select one or more files and/or folders from the list view to convert the file or folder.

On clicking the Start button the user is presented with the following message: Do you want to continue with the
entire folder and sub folders?

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Clicking on No stops this action and the user is taken back to the previous screen.

Clicking on Yes converts all the .plt files available in the folder and sub folders of the selected directory.

Once the conversion is completed the user will be prompted with the following screen, with details about the
number of files, total number of converted files, processing time, number of files specific to the type of instrument,
invalid files, and failed files.

Click here to open processed files: Opens the directory where the converted .pltx files are stored.

Summary button: Opens the csv file, which contains the summary details of the conversion.

To open the converted files directory -> Click on “Click here to open processed files”.

The tool will redirect to the folder where the converted .pltx files are stored.

 The name of the converted files in the directory will be unique for every conversion. An example for a
converted files directory is PLTX_04122022041245.
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  The software creates the converted files directory in the input folder path.
 The converted files will have sub directories based on reader type of successfully converted files.
 In the converted files directory, the failed files folder will have sub directories based on reader type for the
failed files. If the reader type is not known, then the failed files will be stored in the sub directory with the
directory name other files.
 If the .plt file is not supported for conversion due to invalid reader type, then those files will be kept under
the Invalid files folder.

To open the conversion summary report, click the Summary button.

The tool will redirect to the .csv file.

 For every batch of converted assays, a new .csv file is generated.

 The .csv file contains the details of converted files such as total number of files, total number of files
converted, processing time (mm:ss), number of successfully converted files with reader type information,
number of failed files, and number of invalid files.

PLTX Assay Splitter

Start the application using the following exe -> EndoScanV.Tools.PltToPltxConverter.exe

Switch the tab to PLTX – Cartridge Assay Splitter.

The below image shows the PLTX – Cartridge Assay Splitter dashboard.

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  Choose PLTX Folder button: Opens the browse folder window, which contains all the available directories in
the computer so that the user can select the .pltx files from the folder.
 Input Folder Path: Displays the path of the directory that the user selected from the browse folder window.
 Go back button: The user can redirect to the previous directory from the current directory.
 Start button: Splits the assays if a cartridge .pltx file contains multiple assays.
 Close button: Application will be closed.

Click on “Choose PLTX Folder” button.

The browse folder window will open allowing the user to select the folder containing the .pltx files.

Select the folder that contains the .pltx files and press on the OK button.

The tool will show all the available .pltx files in the selected folder.

Click on the Start button to split all the assays from the .pltx file available in the selected folder.

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Note: Users can select one or more files and/or folders from the list view.

Upon clicking Start, the user is presented with the following message: Do you want to continue with the entire
folder and sub folders?

Clicking on No stops this action and the user is returned to the previous screen.

Clicking on Yes splits the cartridge .pltx files, which have multiple assays from the folder and sub folders of the
selected directory.

Once the conversion is completed the user will be prompted with the following screen. Details about the number
of files, total number of processed cartridge files, total number of cartridge assays separated, total number of
duplicate cartridge assays, processing time, number of invalid files skipped, and number of files failed to split
assays will be presented.

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 Click here to open the processed files: Opens the directory where the separated cartridge .pltx assay files are
stored.

Summary button: Opens the .csv file that contains the summary details of the separated assays.

To open the separated assays files directory, click on “Click here” to open the processed files. The tool will redirect
to the folder where the separated assay files are stored.

 The name of the separated assays files directory will be unique for every conversion. For example, a
converted files directory is formatted as CartridgeAssays_05032022031220.
 The software creates the separated assays files directory in the input folder path.
 The separated assays files will have sub directories based on successfully separated cartridge files, duplicate
files, invalid files, and failed files.
 If the .pltx file is not cartridge reader type, then those files will be kept under the Invalid files folder.
 If the .pltx files failed to do the conversion, then those files will be kept under the Failed files folder.

To open the separated assays summary report -> Click the View summary button.

The tool will redirect to the .csv file.

For every batch of assays separated a new .csv file is generated.

The .csv file contains the details of separated cartridge assay files such as total number of files, total number of
processed cartridge files, total number of cartridge assays separated, total number of duplicate cartridge assays,
processing time (mm:ss), total number of invalid files, and total number of failed files.

8 EXPORT

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An authorized user can export any assay in the database to a .CRL, .CSV, or .XML file(s). The user can choose an
assay in the database, the file format, and then the file directory where the exported file will be stored.

The user can choose to export one file or a group of files. They can select a group of files by holding down the
control and shift keys as they select each file.

Once the records are selected, you then can choose what type of export file you would like by selecting the Export
button.

Export as .CSV or .XML will export in that file type.

Export as .CRL will encrypt the file so that it can be emailed to Charles River for support. Only Charles River licensed
employees have the software able to open a .CRL file.

If you choose to export more than one assay, the assay records are concatenated into one file. The user can choose
what folder to place the file into.

Export File Naming Convention

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 The Export file name will be the concatenation of:

EndoScanV-Export-Timestamp (YYYYMMDDHHMMSS). CSV, XML, or CRL

Example: EndoScanV-Export -20190222113356.csv

9 COPY FROM/CREATE TEMPLATE (MICROPLATE MODE ONLY)

This icon in Microplate Mode will present the user with a drop-down box as follows:

Note: If a user has an open grid and leaves the software open overnight, and then utilizes the same instance of
software without exiting, the assay naming convention will have the date from the previous day. The software
knows when the new assay was created and doesn’t name based on the date it was run.

9.1 Create Template

Templates can be created, edited, and deleted by authorized users. Creating templates allows the user to control
the assay setup so that other users can create new assays from these templates.

Navigate to New Assay in the main menu and choose Create Template. Enter a Template Name for the new
template and select OK to continue.

Image 9-1 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

Set the Assay Type, add Samples and Standards, and configure Assay Properties. When ready, select Save from
the Dashboard toolbar to add the new template to the database.

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 Image 9-2 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

To make changes to an existing Template, navigate to Results in the main menu to open the Assay Explorer in
Results mode. Locate your target Template using the filters at the top of the table and double-click the row to open
it in the Endogrid.

Configure your changes and then select Save from the Dashboard toolbar to update the Template.

Image 9-3 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

To delete a Template, follow the same steps to modify but instead of double-clicking to open the template in the
Endogrid, select the Template once to highlight the row and choose Delete from the top right of the window.

9.2 Copy From

Copy From allows users to create a new assay from an existing Template or use a completed assay as a template
for a new assay. Using Copy From creates a copy of the original Template or completed assay used; no details of
the original are changed when using this function.

To use Copy From, users must first connect an instrument and mark it as active in the Instrument Manager. If there
are no active instruments, this option is disabled in the New Assay menu.

Navigate to New Assay in the main menu and choose Copy From to open Assay Explorer in Copy From mode. Use
the filters at the top of the table to locate the Template or completed assay and double-click the row to create a
new assay using the details from the copied template or completed assay.

Before the assay is created from the template, users must assign an instrument and Assay Type to the new assay.
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 To assign an instrument, choose an option from the Instrument Serial Number drop-down list of active
instruments. If the original template or completed assay has an Assay Type assigned, the new assay will be created
with that type; if not, choose one now in the Assay Type drop-down list. Choose OK to load the new assay to the
Endogrid.

Only active, idle instruments may accept new assays for configuration; if all instruments are currently busy running
other assays, the system will serve a message advising all instruments are currently busy and the new assay will not
be added.

Image 9-4 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

Note: When using Copy From using a completed assay as a template, the Collection Time value from the original
assay will not be copied over to the new assay; the default value for all new assays will be used instead.

10 SETTING UP AND RUNNING A MICROPLATE ASSAY

If creating a new assay from a previous assay or template, follow the instructions in Section 9.

When one or more microplate instruments of the same type are marked as active in the Instrument Manager, the
Dashboard will open a tab for every active instrument. Each tab contains a toolbar to manage instrument functions
and configure assays, a 96-well grid interface, and a status ribbon which displays instrument and assay information
in real time.

From here, users may configure a new assay by adding samples and standards to the grid directly (see Section 10.1)
or leverage the Copy From feature to use a predefined assay configuration (see Section 9.2).

10.1 Adding Samples and Standard to the Template Grid

Before Samples or Standards may be added to the grid, users are required to select the Assay Type.

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Image 10-1 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

Located in the toolbar above the well grid and to the left of Views, the Assay Type describes the type of reagent to
be used in the assay. Used with the Performed With value on the Sample, these fields work together to ensure
users are correctly matching the reagent used in the assay with the reagent required for the sample.

To set the Assay Type, select one of the following from the drop-down
menu:

 LAL (Limulus amebocyte lysate)

 rCR (recombinant Cascade Reagent).

Note: When the Assay Type is set to “rCR”, the Collection Type in Assay
Properties is automatically set to “Kinetic Chromogenic” and may not be
changed.

If users attempt to add Samples or Standards to the grid before assigning

the Assay Type, the system will block the user from adding the item and
will receive a message reminding them to configure this field before
continuing: “Please choose an assay type before adding
samples/standards/controls to the grid.”

Once the Assay Type is configured and as users add samples to the well
grid, the system will perform validation against the Performed With field
on the Sample record to confirm the reagent assigned to the assay
matches the reagent assigned to the sample.

If the values match, the system will allow the sample to be added to the
well grid.

If the values do not match, the system will not add the sample to the
assay and instead serve a message to the user warning of the mismatch:
“Assay type chosen is [LAL or rCR], this sample is to be performed with
[LAL or rCR].”
Image 10-2 "Please choose an assay
type before adding samples/standards/
controls/accessories to the grid."

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 Image 10-3 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

The user can cut Standards and Samples after they have been added to the template and paste them in another
location. When cutting on the screen the user will find the following pop up:

Image 10-4 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

Click OK to accept the changes.

When pasting the cut Standards or Samples, users will receive a notification to confirm the change as follows:

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 Image 10-5 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

Click OK to accept the changes.

 If the desired sample or standard replicate will not fit in the desired pasted location, the software will look
to overwrite the information in the other wells; please check the pop-up screen that warns of the change.

 When adding standards to a plate, if the replicates will not fit in the desired wells, the software will look to
overwrite information in the other wells; please check the pop-up screen that warns of the change.

 When adding samples to the template in outer wells, the samples and spikes will wrap to the other side of
the plate. If the action will overwrite other wells a pop-up screen warns of the change and asks to confirm.

 When cutting samples/standards, the user will be allowed to cut and paste to other wells. If the action will
overwrite other wells a pop-up screen warns of the change and asks to confirm.

 When cutting standards from a template prior to an assay being run, the standards will be deleted from the
plate and the standards list. The software will notify the user with a message.

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Click OK to accept the change.

When deleting samples from a plate prior to an assay being run, all highlighted fields will be deleted, including the
spike wells.

The software will notify the user with a message of the changes; click OK to proceed.

Based on the user’s privileges, the user will be able to delete standards/samples when an assay is complete.

Each assay will require the user to add standards to the assay grid before starting the assay. If the user fails to do
so, a dialog box will appear that states: “Warning: there are not enough standards defined on the plate to perform
the desired regression. Do you want to continue anyway?” Selecting Yes will allow the plate to start without
standards added to the plate.

If an assay is closed while the assay is running, a prompt will display: “You are about to stop the assay testing
<ASSAY NAME>. Do you want to stop?” Selecting Yes will close the assay and save the file. A note will be made in
the Audit Trail that the assay was closed prior to all standards/samples reacting.

The minimum number of replicates are 1 and the maximum replicates is 96.

The software has the ability to run multiple standard curves on one template and calculate the standard curve
reaction times separately.

The toolbar above the well grid contains the following functions::

Assay Properties

Cut

Copy

Paste

Undo

Redo

Print Grid

Plate In
(PRS Only)

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 Plate Out
(PRS Only)

Start Collection

Stop Collection

Save (for use when

saving Templates)

10.2 View List

Users may toggle between different Views of the well grid. Located in the Dashboard toolbar, use the drop-down
menu to select a View.

Image 10-6 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

The available views in EndoScan-V™ are Template, OD Graph, Max V, Reaction Time, EU, and Data Values. Select
the desired view from the drop-down list.

 Template View displays the text designators of the well contents. In the Template View, the menu bar also
includes a Replicate selector. The Replicate selector multiplies the sample, standard, or control by the
number selected when the item is added to the grid area. In this view, the Properties dialog box can be
edited through the properties icon at the top of the grid, or by using the right mouse button menu on a well
or wells and selecting properties. Additionally, the right mouse button will allow a user to Undo, Cut, Copy,
Paste, Clear, or Mask; these functions can also be accessed via the icons at the top of the grid.
 OD Graph View shows a graph of Optical Density (OD) versus time for each well. This view is available
during and after data collection for kinetic collections only. The Well Zoom feature can be used in this view
to “zoom” into a well, providing an expanded view of the well information. To display a Zoom window for
the currently selected well, double-click a well. Multiple well Zoom windows may be open at one time.
 For PRS instruments only, when in OD Graph View the Well Zoom window includes an additional field for
instrument Temperature.

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 Image 10-7 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

 MaxV View shows the maximum slope (Max V) value for each well. This view is available after data
collection for kinetic collections only.
 Reaction Time View shows the time to the Onset OD value for each well. This view is available after data
collection for kinetic collections only.
 EU View shows the Endotoxin Unit (EU) value for each well. This view is available after data collection.
 Data Values View shows the numeric optical density (OD) values for each well. For kinetic collections, the
operator may step through the series of values by changing the read number on the menu bar. This view is
available during and after data collection of a kinetic endpoint assay.

10.3 Print Grid

Each of the above views can also be printed. This can be achieved by selecting the View and then choosing Print
Grid from the Dashboard toolbar. The system will generate and open a PDF of the grid as it appears in your
selected View.

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 Image 10-8 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

10.4 Read Number and Read Time

The Read Number is a count of the number of data reads the program has made during a data collection. In the
Data Values View on kinetic collection, the Read Number can be changed to view the optical density value for each
read.

The Read Time box indicates the time that a data collection has been running. In the Data Values View, the Read
Time field indicates the time of the read corresponding to the Read Number.

Image 10-9 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

10.5 Well/Grid

Each cell in the Well Area grid represents an individual well. The wells are named using an alphabetic character (A-
H) for the row and a numeric character (1-12) for the column. For example, G3 or C11.

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The text options for each well are the sample name or one of the following designators: SPL# (sample), SPK#
(spike), STD# (standard), and CTRL (control). Sample, spike, and standard have a number associated with the text to
indicate to which group the sample, spike, or standard belongs.

Samples, spikes, standards, and controls are entered onto the plate either by dragging and dropping from their
respective area (including from the sample and accessory database) or by entering or editing the contents of a well.

Using the drag and drop method, the name of the sample (abbreviated as necessary) is displayed in the well area.
Information from the sample area for the sample is copied into the well and can be viewed using the well
properties menu. Replicates may be entered either from top to bottom or from left to right, based on operator
preference. Spikes are entered into the wells either by automatic creation of spikes or by entering or editing the
well information. If automatic spike creation is selected in the global settings, spikes and spike replicates are
automatically added to the plate. The first sample entered on the plate is designated as SPL1, the next is
designated as SPL2, and so on.

Well information can be created using the keyboard or editing by selecting the text in a well and using the
keyboard. Other editing options can be accessed using the right mouse button on a well.

10.6 Standards and Samples Lists

Standards List

The Standards List of the Main Window provides user access to the Standards List during assay configuration. The
Standards List displays the general standards available and the standards on each open assay. Standards for each
plate are indicated under the assay name.

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Standard Sets are entered onto the grid by clicking on the row containing the desired standard set and dragging the
highlighted standard set onto a well in the Well Area. If the standard set is not already on the grid, it will be added
to the list of standard sets under the assay name.

New Standard Sets may be added by entering the Standard Set name, using the appropriate naming convention as
in the default Standard Sets, and Concentrations in the appropriate blank row.

Sample Information

The Sample Information Area of the Main Window provides a list of all samples, spikes, and controls entered onto
the grid during the assay setup under the assay name. This area provides the group information, the product name,
and the product’s lot number. Lot numbers can be typed directly into the sample information grid or added via the
Properties window. Refer to section 10.7 on Properties.

Items listed in this window can be dragged onto the grid during assay setup by holding down the right mouse
button and dragging and dropping onto the appropriate well.

New samples, spikes, and controls may be added by entering the group name in the appropriate blank row. The
group name, product name, and lot number may be edited directly on the Sample Information area. To remove a
sample, spike, or control, highlight in the grid those to be deleted, right click, and press cut.

To create a negative control, drag from the Drag for Negative Control area. Controls will be added into the wells,
following the automatic replication set for the microplate.

10.7 Assay Properties

There are two (2) methods for opening the Assay Properties window: Select Assay Properties from the Dashboard
toolbar or right-click in any cell in the well grid and choose Properties.

The Assay Properties window opens by default on the Well/Group tab but there are four (4) tabs in total:
Well/Group, Assay, Collection, and Calculations.

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 Image 10-10 Assay Properties: Well/Group Image 10-11 Assay Properties: Assay

Image 10-12 Assay Properties: Collection Image 10-13 Assay Properties: Calculations

Assay Properties: Fields And Descriptions

WELL/GROUP TAB
The Well/Group tab allows the user to set the properties for the well and samples, spikes, controls, and standards (groups of
wells) contained in the current assay.
Well Details
The well details list displays the groups of samples, standards, spikes, and controls entered on the grid.
When group identifier in this list is selected, it is highlighted and the fields to the right of the list show
properties of that item. Information in these fields can be edited.
 To display a list of which wells contain a group, click on the plus sign by the
group identifier. To hide the list of wells, click on the minus sign by the
group identifier.

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WELL/GROUP TAB
The Well/Group tab allows the user to set the properties for the well and samples, spikes, controls, and standards (groups of
wells) contained in the current assay.
Sample Name
The Sample Name field identifies the sample name of the sample or spike selected in the Group/Well
list. This will be pre-populated if added from the sample database.
Sample Lot Number
A user can add the sample lot number.
Sample ID
A user can enter a sample ID for the sample.
 This will be pre-populated if added from the sample database.
Dil./Conc. (Dilution/Concentration)
Enter the Concentration or Dilution for the sample or spike.
 If the dosage units are milliliters, this value can be expressed as a Dilution, i.e., a ratio
(1:10).
 If dosage units are other than milliliters, this value must be expressed as a Concentration,
i.e., a decimal number.
Changing the Concentration/Dilution for a sample changes the Concentration/Dilution displayed for the
sample’s spike, and vice-versa. This will be pre-populated if added from the sample database.
Associated Standards
The Associated Standard Set is the standard set that will be used to evaluate endotoxin for this group.
 More than one standard set can be included on a single assay.
 Select the standard set from the pull-down list.
Changing the Associated Standard Set for one well/tube in a group will change the Associated Standard
Set for all other wells/tubes of that group. Changing the Associated Standard Set for a sample will
change the Associated Standard Set for the sample’s spike, and vice-versa.
Endotoxin Limit
This field contains the Endotoxin Limit for a sample or spike.
 This value is used on reports.
Changing the Endotoxin Limit for a sample changes the Endotoxin Limit for the sample’s spike, and vice-
versa. This will be pre-populated if added from the sample database.
Std Curve Orientation
A user can choose to have the standard curve in ascending or descending order.
 The user must set the Std Curve Orientation PRIOR to drag/drop of the Standards onto the
grid.
 The default for all plates is standards in descending order; this setting must be done at the
plate level each time to change to ascending.
Spike/Standard Concentration
For a sample, enter the amount of endotoxin spike for the sample. For a spike or standard, enter the
endotoxin concentration of the spike or standard.
 This will be pre-populated if added from the sample database.
Performed With
This field is read-only and will display the Performed With value assigned to the sample(s) currently
included in the assay.
 If samples have not yet been added to the assay configuration, the field will be blank.
Mask
The Mask checkbox indicates whether the selected well is masked.
 It is always unchecked when no well is selected.
 The Mask checkbox is enabled when a well identifier is selected (highlighted) in the
Group/Well list and the user has masking privileges.

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WELL/GROUP TAB
The Well/Group tab allows the user to set the properties for the well and samples, spikes, controls, and standards (groups of
wells) contained in the current assay.
Automatic Creation of Spikes
When selected, the Automatic Creation of Spikes property directs the program to automatically create
a spike group for the sample when it is entered onto the assay.
 To select this property, click the Automatic Creation of Spikes checkbox.
 This will be pre-populated if added from the sample database.
Sample Comments
The Sample Comments field is available to enter a text description of a sample or spike.
 Changing the Sample Comments of a sample changes the Sample Comments of a spike, and
vice-versa.
Group Criteria
The Group Criteria are the equations to be evaluated as true or false for the assay by EndoScan-V™.
 Criteria entered into the Group Criteria field will be included on reports for the assay.
 Enter all applicable criteria for the plate, connecting criteria expressions with logical “AND”
operators.

ASSAY TAB
Lab Name
User can enter the laboratory name.
Endotoxin Units
Determines what unit the assay will be calculated in. Options are EU (Endotoxin Units) or IU
(International Units).
 NOTE: 1EU = 1IU.
Assay Comments
Comments can be added for the assay that will be added to the report.
Auto Stop
Selection of Auto Stop will complete the assay once Lambda has reacted.
Accessories
These are the accessories that have been added to the assay either by them being listed as default in
the accessory database, or by being dragged and dropped onto the grid.
 Accessories can be deleted by those authorized to do so from the assay on this screen by
checking the Delete cell for each Accessory to remove from the assay.
 To save this change, select Apply to save and remain on Assay Properties or select OK to
save the change and close the window.

COLLECTION TAB
Instrument Properties
Collection Time
Collection Time is used for kinetic collections only.
 Entering the desired number of seconds in this box sets the maximum Collection
Time for the entire collection, specified in seconds.
 For PRS instruments, the Collection Time must be set to a minimum of 60 seconds; if
users enter a lower value, the system will automatically update the field to the
minimum value.

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COLLECTION TAB
Read Interval
Read Interval is used for kinetic collections only. The number of seconds entered in this field
defines at what interval data is gathered during a data collection.
 Enter the desired Read Interval, in seconds, into this field.
 If the selected reader cannot support the defined Read Interval, it will be adjusted as
needed and indicated on the display.
 For PRS instruments, the Read Interval must be set to a minimum of 60 seconds; if
users enter a lower value, the system will automatically update the field to the
minimum value.
Plate Temperature
Displays the temperature, in degrees Celsius, of the assay at the beginning of collection and at
the end of collection.
 The temperature is not displayed before collection or if the instrument does not have
an incubator.
 This field is disabled if the assigned instrument cannot report assay temperature.
Plate Temperature Setting
The temperature entered in this field is the desired temperature to which the plate should be
warmed.
 Enter the desired temperature, in degrees Celsius, for the plate, if the instrument has
a heater.
 The default setting is 37 (degrees Celsius).
Wavelength
Specific filter wavelength values supported by the instrument will be listed in the pull-down menu
with the default value assigned based on the Collection Type selected. Select filter wavelength
from the drop-down list or enter a custom value by typing into the field.
 List of supported values: 340, 405, 490, 620, 630.
 If the custom value is used, the system will check to confirm the selected filter value
is valid for the connected instrument.
Instrument
The Instrument area of the Collection tab displays the information for the selected instrument.
 Instrument Type
 Serial Number
 Port Number
 Baud Rate
Shake
For instruments with a shaker device attached, the shake intensity and time can be controlled by the
EndoScan-V™ software. This property will be disabled if it is not supported by the instrument.
Select Shake Enable to have the instrument shake the plate at the intensity and time indicated in the
Shake Intensity and Shake Time fields.
Shake Intensity
Enter the desired Shake Intensity of the assay in this field.
Shake Time
Enter the time—in seconds—for the microplate to be shaken prior to beginning data collection.
Shake Enabled
Check or clear to enable or disable this setting.

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COLLECTION TAB
Collection Type
Three (3) types of data collection can be performed using the EndoScan-V™ program for a microplate
instrument: Endpoint, Kinetic Chromogenic, and Kinetic Turbidimetric.
 Set the Collection Type by selecting the radio button by the desired Collection Type.
 The default Wavelength value will change depending on the Collection Type selected, and
some Assay Types restrict which Collection Types are available.
Endpoint
Endpoint collection gathers data from the assay a single time and then automatically stops.
Kinetic Chromogenic
Kinetic Chromogenic gathers data from the assay over a user-specified collection time, measuring
the color change of the samples, standards, spikes, and controls on the assay.
Kinetic Turbidimetric
Kinetic Turbidimetric gathers data from the assay over a user-specified collection time, measuring
the change in turbidity of the samples, standards, spikes, and controls on the assay.

CALCULATIONS TAB
Regression
The EndoScan-V™ software is capable of performing either Linear or Polynomial Regression to
determine the standard curve. Select the type of regression desired for the assay.
 For Linear Regression to be performed there must be at least three (3) data points
defined.
 For Polynomial Regression to be performed there must be one (1) more data point
than the defined Polynomial Order.
 If Polynomial Regression is selected, the Polynomial Order option will be enabled.
 If the selected order, or degree, of polynomial regression cannot be performed due to an
inadequate number of standards or points, linear regression will be used to determine
the standard curve.

The regression value is calculated using the following algorithm, where R is the Correlation Coefficient
for the regression line:
TestStatistic= R* SquareRoot(#points-2) divided by SquareRoot (1-R2)

Polynomial Order
Polynomial Order value is established by selecting the value from the pull-down list.
 The possible values are 2, 3, and 4.
Onset OD
The onset optical density (OD) defined for an assay.
 Enter the desired onset OD.
CV Limit – Samples
EndoScan-V™ calculates the coefficient of variation (CV) of the well results for each sample and spike.
 The limit entered into this field, in percent, is the acceptable limit for sample and spike
CV and will be included on reports.
 The CV% is calculated using the standard deviation of the replicates. Standard Deviation
is calculated using the following equation:
SD= SquareRoot(Sum divided by # points)
 The CV is used for samples and standards; it is calculated using the
following equation:
(Standard Deviation divided by the Mean) x 100

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CALCULATIONS TAB
CV Limit – Standards
EndoScan-V™ calculates the coefficient of variation (CV) of the well results for each standard and
control.
 The limit entered into this field, in percent, is the acceptable limit for standard and
control CV and will be included on reports.
 CV is calculated as noted in CV Limit – Samples.
Y Axis Maximum
Optical Density is plotted on the Y axis.
 When a new assay is created, the Y Axis Maximum is set to 3 times the
Onset OD.
X Axis Maximum
Time is plotted on the X axis.
 Typically, the X Axis Maximum should be at least the actual collection time.
# (Number) of Points to Use for MaxV
The number of data points used to calculate the maximum slope or MaxV.
 Possible options for the number of data points are 2, 3, or 4 data points.
 This is only used during the Performance Qualification.
Spike Recovery Range
EndoScan-V™ calculates spike recovery as a percentage for spiked sample groups.
 The software uses the following equation to calculate Spike Recovery:
100 * (EU of Spiked Group-EU of Sample Group)
divided by Theoretical EU of Spiked Group
Enable Validation
Selecting this option directs the program to evaluate the well criteria (found under the well/group tab)
for the assay.
Show CV Prefix
Selecting this option will add the < or > prefix before the %CV if the calculation criteria warrant it.
Average Replicates
When Average Replicates is selected, EndoScan-V™ will average the reaction times of each well in a
sample, spike, control, or standard group before calculating the group endotoxin value. Otherwise, the
group endotoxin value is the mean of the well endotoxin values.

10.8 Starting an Assay

Once all samples, standards, and controls have been added to the assay and all information is complete, proceed
to preparing the microplate.

For PRS Instruments Only

Use Plate Carrier In and Plate Carrier Out to control the Plate Carrier tray on the instrument.

Plate Carrier In
Close the Plate Carrier tray.

Plate Carrier Out

Open the Plate Carrier tray.

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 PRS Instruments have a feature
which allows users to set and
monitor the instrument’s
internal Plate Temperature.
(See Assay Properties–
Collection Tab: Plate
Temperature)

For PRS instruments, the “Start

Collection” button will be
disabled until the instrument
reaches the Plate Temperature
value.

By default, the Plate

Temperature is set to 37°C.

Once the microplate to be assayed is ready, load the microplate into the instrument and select Start Collection.

Start Collection

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 Image 10-14 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

The assay will begin collecting data.

The assay can be stopped before it completes via time assigned or auto stop. This can be done by clicking the Stop
Collection icon.

Note: When the microplate instrument is running an assay, the “Clear Grid” button should be disabled by default;
this is to prevent users from inadvertently clearing the grid before the system is able to save the assay data which
may result in data loss.

Stop Collection

The screen below shows when the instrument is connecting:

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 Image 10-15 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

If the instrument does not connect, click the Reconnect Instrument button. If connection issues continue, refer to
section 4.4 on Instruments in this manual.

The screen below shows when the instrument is connected and ready:

Image 10-16 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

The screen below shows when the instrument is Running and Collecting Assay Data:

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 Image 10-17 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

The screen below shows when the assay has stopped collecting data:

Image 10-18 Example image for Microplate Mode taken using a PRS instrument; other instrument dashboards may have different options.

11 CARTRIDGE MENU (CARTRIDGE AND NEXUS 200 MODES ONLY)

When in the Cartridge Reader Mode a user can select the Cartridge menu under the cartridge icon:

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When selected a drop-down menu will appear:

All functions under this menu can be completed on nexgen instruments.

 Download Logs

Selecting Download Logs will save the application (nexgen instruments only) logs and Audit Trail PDF (nexgen
instruments only) from all the panels that are connected and visible to EndoScan-V™. The application logs are
retrievable as text files, and the Audit logs are retrievable as PDF files.

The application logs are different than the test reports. These logs show the reader self-check, the IR intensity, and
the UV intensity and can assist Technical Support in troubleshooting any issues concerning the reader or the assay.

The Audit Trail log shows the Audit Trail from the panel of each instrument (and it is not the EndoScan-V™ Audit
Trail). The Audit Log will show the beginning and end of every test, whether a test was aborted, and if any settings
have been changed. The user will appear as N/A, as EndoScan-V™ only sends down the username for test result
information.

When Download Logs is selected, it will provide the option of ‘Last 100’ or ‘All’; when one is selected it will search
for logs on the connected device as follows:

The storage path is the Export File Path setting in Global Settings and will be stored in a folder for each bay, with
the folder name being the IP address for each bay.

 Download Results

For nexgen instruments, selecting Download Results will retrieve all Results from the instrument. When done, a
notification will summarize how many assays were downloaded.

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The assay name for a downloaded result is based on the FLT file name on the nexgen (e.g., FLT name is
FLT20170817071123.txt, so the assay name is 201709171071123). The assay name and the instrument bay serial
number make the downloaded test result unique.

Any assay stopped before completion is not loaded into the results database.

 Instrument Version

This command displays serial number and software version information for connected cartridge instruments.

 nexgen Instrument Software Update

Selecting nexgen Instrument Software Update allows the user to update the instrument firmware. The user selects
the update file.

If a user selects update software, it will update all connected panels from this menu. The user can update software
individually by bay under the Cartridge panel cog. The software update operation is associated with the privilege
“nexgen Instrument Software Update”.

 Reconnect
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 Selecting Reconnect will result in EndoScan-V™ attempting to reconnect to the default instruments.

Reconnect is done when a) the Reconnect menu item is selected on this screen, b) the default instrument has been
changed, and c) a bay is selected for reconnection within the Manage Instruments screen. This Reconnect function
will prompt the user if assays are running in any panel to confirm the Reconnection. The Reconnect operation is
associated with the privilege Reconnect.

 Restart

Selecting Restart will result in EndoScan-V™ attempting to restart the instrument.

 Shutdown

The shutdown function will shut down all bays on the nexgen instrument. The Shutdown operation is associated
with the privilege Shutdown. The shutdown can take several minutes.

The user can shut down individual bays under the “Manage Instrument” window.

NOTE: The nexgen-MCS™ MUST be shut down using this function. Utilizing the power button on the rear of the
instrument can result in a power toggle situation or files not being properly written to the bay. Improper shutdown
of the nexgen-MCS™ can result in failures within the instrument. It is very important that the proper shutdown
procedure is followed.

If the nexgen-MCS™ is shut down via EndoScan-V™, the power button on the back of the instrument must be
pressed to turn it back on.

12 SETTING UP AND RUNNING A CARTRIDGE ASSAY (CARTRIDGE MODE

ONLY)
For setting up a Nexus 200 assay please refer to the Nexus 200 User Manual.

When any PTS™ instrument is set as the Active Instrument, the cartridge interface will be displayed. This can take
different forms depending on whether this is a nexgen-PTS™ or nexgen-MCS™ instrument.

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12.1 nexgen-MCS™ Cartridge Panel

This section reviews the information found on the Cartridge Panel display.

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  Instrument Icon: Displays an icon of the
nexgen-MCS™ instrument.
 Tab and Bay Numbers: Example “2-1” refers
to Tab #2 and Bay #1.
 Instrument Serial Number: Identifies the
instrument.
 Bay Serial Number: Identifies the bay within
the instrument.
 Assay Name: Combination of Assay Prefix
(configured in Global Settings), Bay Serial
Number, Panel Number, Date (in
YYYYMMDD format), Sequence Number (set
on the bay, reset daily, increments with each
new assay), and Assay Suffix (configured in
Global Settings).
 Status Indicator: See nexgen-MCS™
Cartridge Panel Test Sequence for more
information.
 Assay Setup: See nexgen-MCS™ Assay Setup
for more information.
 Assay Results: See nexgen-MCS™ Assay
Result Screen for more information.
 Test Sequence Message: See nexgen-MCS™
Cartridge Panel Test Sequence for more
information.
 Bay IP Address: Identifies the IP address of
the bay within the instrument.
 Cartridge Panel Menu: Opens the Cartridge
Panel Menu where users can download log
files, send commands to the instrument,
download results, etc.
 Cartridge Type: Displays the current
Cartridge Type assigned to the assay based
on the Cartridge Lot # assigned; will be blank
until Cartridge Lot # entered.

12.2 nexgen-MCS™ Assay Setup

Field Name Requirement Source
Cartridge Lot Mandatory Pulled from Accessory Database – If global settings option for open fields is
Number chosen then user can type in.
Cartridge Code Mandatory Pulled from Accessory Database – If global settings option for open fields is
chosen then user can type in.
Sample Name Optional Pulled from Sample Database or typed in by user.
Sample Lot Optional Typed in by user.
Dil./Conc. Mandatory Pulled from Sample Database or typed in by user.
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 Endotoxin Limit Optional Pulled from Sample Database or typed in by user.

Sample Information can be filled by dragging and dropping a row from the Sample Database.

Accessory information can also be added to the panel. Authorized users can type in the cartridge lot number and
calibration code directly onto the panel. If cartridge lot number is manually typed into the panel, the expiration
date for the cartridge lot number will display as N/A.

For Cartridge Accessory Types, when a Cartridge accessory type is added to the assay, the system will update the
Cartridge Type in the bottom right corner of the Assay panel based on the Cartridge Lot #; until a Cartridge Lot # is
added to the assay (by typing it in or by adding a Cartridge accessory type) the field will be blank.

 Accessories can be added by dragging and dropping from the Accessory Database onto the panel.
 Accessories can be deleted from the panel by highlighting the accessory and clicking delete.

12.3 nexgen-MCS™ Run Assay

Each panel has a status bar that displays the current activity. For a typical nexgen-MCS™ assay, the status will move
through the following stages:
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Color chart:

Not ready to begin

Red test or Test
Completed
Bay Connected;
Green
Ready for Cartridge
Cartridge Detected
Assay Setup in
Blue
Progress or Assay in
Progress

Grey Bay not connected

Order Status Panel User’s Next step Status Beep

color
1 Enter Assay Configure the Assay N/A
Setup Parameters and Insert a
Cartridge
Insert
Cartridge

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 Order Status Panel User’s Next step Status Beep
color
2 Checking Wait for Status to change N/A
Cartridge to “Enter Assay Setup”.

3 Enter Assay Select “Send Setup” N/A

Setup

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 Order Status Panel User’s Next step Status Beep
color
4 Sending Assay Wait for Status to change Yes
Setup to “Add Sample and Click
Start”.

5 Add Sample Select “Start” N/A

And Click
Start

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 Order Status Panel User’s Next step Status Beep
color
6 Preparing None N/A
Assay

7 Performing None N/A

Assay

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 Order Status Panel User’s Next step Status Beep
color
8 Assay Remove cartridge Yes
complete –
Remove
cartridge if
inserted

9 Initializing Select New Assay to start Start

Remove a new test. back at
Cartridge if step
Inserted one.

(Optional)

Waiting for
Temperature

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 Order Status Panel User’s Next step Status Beep
color

12.4 nexgen-MCS™ Assay Result Screen

See nexgen-PTS™ Assay Result section.

12.5 nexgen-PTS™ Cartridge Panel

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  Instrument Icon: Displays an icon of the
nexgen-PTS™ instrument.
 Tab and Panel Numbers: Example “2-1”
would refer to Tab #2 and Panel #1.
 Instrument Serial Number: Identifies the
instrument.
 Assay Name: Combination of Assay Prefix
(configured in Global Settings), Bay Serial
Number, Date (in YYYYMMDD format),
Sequence Number (set on the bay, reset
daily, increments with each new assay), and
Assay Suffix (configured in Global Settings).
 Status Indicator: See nexgen-PTS™ Cartridge
Panel Test Sequence for more details.
 Assay Setup: See nexgen-PTS™ Assay Setup
for more information.
 Assay Results: See nexgen-PTS™ Assay Result
Screen for more information.
 Test Sequence Message: See nexgen-PTS™
Cartridge Panel Test Sequence for more
information.
 Bay IP Address: Identifies the IP address of
the bay within the instrument.
 Cartridge Panel Menu: Opens the Cartridge
Panel Menu where users can download log
files, send commands to the instrument,
download results, etc.
 Cartridge Type: Displays the current
Cartridge Type assigned to the assay based
on the Cartridge Lot # assigned; will be blank
until Cartridge Lot # entered.

12.6 nexgen-PTS™ Assay Setup Section

See nexgen-MCS™ Assay Setup.

12.7 nexgen-PTS™ Run Assay

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Step 1

The panel will display “Enter Assay Setup Insert

Cartridge” and the status light at the top right corner of
the panel will be green.

In this step, users will configure the assay parameters.

Users will notice once the Cartridge Lot # field has

been configured, the panel will display the Assay Type
in the lower right corner.

Step 1 (Continued)

Once the assay parameters have been configured,

insert the cartridge into the instrument’s bay.

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Step 2

Once a cartridge is inserted into the instrument’s bay,

the panel message will update to “Checking Cartridge”
and the status light at the top right corner of the panel
will be blue.

Step 3

When the instrument is ready, the panel message will

update to “Enter Assay Setup”.

Select Enter Assay Setup to submit the assay

configuration.

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Step 4

Once the user submits the assay parameters, the

system will update the panel message to “Sending
Assay Setup”.

Step 5

Once the assay parameters have been sent to the

instrument, the system will update the panel message
to “Cartridge Warming”.

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Step 6

Once the cartridge has been warmed, the system will

update the panel message to “Add Sample and click
Start”.

At this time, add the sample material to the cartridge

wells.

When the sample material has been added to the

cartridge wells, select Start to begin the assay.

Step 7

Once the user has started the assay, the system will
update the panel message to “Preparing Assay”.

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Step 8

Once the system has completed assay preparation

procedures, the panel message will update to
“Performing Assay [#]” where the “[#]” value is the
amount of time—in seconds—which have elapsed
since the assay began.

Step 9

Once the assay has completed, the system will update

the panel message to “Assay complete, Remove
Cartridge” and the status light at the top right corner of
the panel will be red

Users should remove the cartridge at this time and

review the assay results.

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Step 9 (Continued)

The system will automatically begin preparing for the

next assay and the panel message will update to
“Initializing Remove Cartridge if Inserted”.

If users have not yet removed the cartridge, remove it

at this time.

To begin a new assay, select New Assay.

12.8 nexgen-PTS™ Assay Result Section

In the bottom right corner of the cartridge panel, select the cog icon to open the Cartridge Panel Menu. The
Cartridge Panel Menu options are disabled when an assay is in progress.

 Download Logs (see section 11 Cartridge Menu for more info)

 Save Audit Log
 Restart (see section 11 Cartridge Menu for more info)
 Shutdown (see section 11 Cartridge Menu for more info)
 Save Test Reports
 Download Results (see section 11 Cartridge Menu for more info)
 nexgen Instrument Software Update
 Reconnect (see section 11 Cartridge Menu for more info)
 Assay Status

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Download Logs

This function takes all the logs off the nexgen instrument and saves them in the default directory:

C:\ProgramData\Charles River\EndoScan-V\Export\[NEXGEN SERIAL NUMBER]\[NEXGEN IP ADDRESS]

The cartridge panel will display “Save Logs” once the download is complete.

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Save Audit Trail

This function takes all the logs off the nexgen instrument and saves them in the default directory:

C:\ProgramData\Charles River\EndoScan-V\Export\[NEXGEN SERIAL NUMBER]\[NEXGEN IP ADDRESS]

The Audit Trail log shows the Audit Trail from the panel of each instrument (and it is not the EndoScan-V™ Audit
Trail). The Audit Log will show the beginning and end of every test, whether a test was aborted, and if any settings
have been changed. The user will appear as N/A, as EndoScan-V™ only sends down the username for test result
information.

The cartridge panel will display “Save Audit Log” once the download is complete.

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Save Test Reports

This function takes all the test reports from the nexgen instrument and saves them in the default directory:

C:\ProgramData\Charles River\EndoScan-V\Export\[NEXGEN SERIAL NUMBER]\[NEXGEN IP ADDRESS]

This function is used to refresh the assay status, which will update the cartridge panel to show the current assay
status instead of any other text that has been displayed there.

Before Assay Status, “Save Audit Log” is displayed over the current Assay Status.

After Assay Status, the assay status is now displayed on the cartridge panel.

12.9 nexgen-PTS™ Multiple Bays Display

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 Up to five (5) nexgen-PTS™ systems can appear in one tab at a time. The tab is to be labelled as “PTS 1” “PTS 2”
“PTS 3”.

Multiple nexgen-PTS™ systems are displayed in one tab called 1-PTS.

13 AUDIT TRAIL
The software has a fully searchable Audit Trail which logs specific user and
system actions to support traceability. The Audit Trail is found in the Main
Menu under Tools/Administration by selecting the Audit Trail icon.

When selected, the Audit Trail window will open.

The software Audit Trail captures all actions within the software.

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The Audit Trail From Date and To Date filter range is set to the previous day and the current day, respectively, by
default. If any settings are changed, the next time the screen is accessed, as long as the software has not been
restarted, it will use those settings. If the check box next to the “From Date:” is unchecked, then the Audit Trail will
use the oldest entry as the Starting Date. If the check box next to the “To Date:” is unchecked, then the Audit Trail
will use the most recent entry in the Audit Trail as the Ending Date.

13.1 Date Range Fields

From Date: and To Date: fields contain a built-in calendar.

13.2 Print Button

The print button will preview a report that lists all the audit entries in the current window. If a user has completed
a search and only five (5) records match that search and then they select Print, only those five (5) records will
appear in the report. The report filters will display at the top of the page to include all search criteria and the date
range.

When printing an Audit Trail report, users have the option to apply a manual signature template to the report.
After selecting Print, users are given a choice to display the signature lines on all pages of the report or only the last
page. Select your choice and choose Preview to open the report or Cancel to return to the Audit Trail window.

The report will have a signature box for manual signatures with two (2) lines: Analyst and Reviewer. The order of
the entries listed on the report will be in the same order displayed in the Audit Trail window.

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At the top of the screen the following options are available:

Print: By clicking on Print, the report will print to

a connected printer.

Save: By clicking on Save, the user will have the

option to save the report to a chosen folder as a
PDF. If save is chosen, this does not archive any
information from the Audit Trail.

13.3 Search Criteria Field

The Search Criteria list allows the user to search on specially tagged critical events.

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The Search Criteria field has the following entries:

 Blank – No search criteria selected.

 Add/Modify/Delete/Archive Users – Will search all Audit Trail entries and detail when a user has been
added/modified, deleted, or archived.
 Add/Modify/Delete/Privilege Group – Will search all Audit Trail entries and detail when a privilege group
has been added, edited, or deleted.
 Add/Modify/Delete Sample – Will search all Audit Trail entries and detail when a sample has been
added/modified or deleted.
 Add/Modify/Delete Sample Group – Will search all Audit Trail entries and detail when a sample group has
been added/modified or deleted.
 Changes to Global Settings – Will search all Audit Trail entries and detail when global settings have been
changed.
 Changes to Global Settings Comments – Will search for all Audit Trail entries and detail when comments
have been listed when making a change to a global setting.
 Post Assay Comments – Will search for all Audit Trail entries and detail when comments have been listed
when making post assay changes.
 Signature Applied – Will search all Audit Trail entries that show a digital signature has been applied.
 Signature Cancelled – Will search all Audit Trail entries that detail a cancelled signature.

13.4 Search Keyword Field

The user can type any word into the Search Keyword field and the search function will search all the columns of
the Audit Trail.

13.5 Show PC Name/PC Address Checkbox

This checkbox allows the user to add the PC Name and PC Address to the audit table. The PC Address is the actual
network address of the computer that generated the Audit Trail entry. This checkbox is unchecked by default.

13.6 Show Windows Username Checkbox

This checkbox allows the user to add the Windows Username to the audit table. This information can be useful
when troubleshooting database connection issues. This checkbox is unchecked by default.

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13.7 Display Time in UTC Checkbox

This checkbox allows the user to change the Date/Time time zone from local time to UTC (Universal Time
Coordinated) and adds a new column called Time Zone where the local time zone is displayed for reference. This
checkbox is unchecked by default.

13.8 Audit Entry Table

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Table columns are:

Date/Time – date, time, time zone. Example: 30-May-2018 08:34:50 AM EST. The software will use the system date
on the PC.

Time Zone (Hidden column) – If Display Time in UTC is selected, column 1 will display the UTC time and then
column 2 will display the original time zone, e.g., EST or GMT, etc.

Full Name – Full name of user that created the audit entry.

Windows Username – The Windows username of the user (If Show Windows Username checkbox is selected).

Instrument Serial Number – Serial number of the instrument that generated the entry.

Audit Details – Description of the action. If the Global setting ‘Require Comments for Post Assay Changes’ or
‘Require Comments for Global Settings Changes’ is enabled, the comments will be appended to the text in the
Audit Details column.

Example: Onset OD changed from 0.03 to 0.1. COMMENT: Incorrect Onset OD chosen at start of assay.

PC Name – The network or machine name of the user’s PC.

PC Address – The machine address of the user’s PC.

 Table Sorting

When the user first opens the Audit Trail, all entries will be shown with the latest entry first.

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The user can sort the table by clicking on the column header they would like to sort on. The sorting arrow appears
above the column header – see below.

Clicking on the sorting arrow toggles it between an up and a down arrow. The arrow pointing up  sorts the
column in Ascending order. The arrow pointing down sorts the column in Descending order.

 Table Search and Filter

The user can search the table by hovering over the column header they would like to search on. When the mouse
hovers over the column header, the search arrow appears to the right of the column header if the field is
searchable.

A search column window appears when the arrow to the right of the column is clicked. You can select what values
you would like to include by clicking the check boxes. The window also allows you to type in a specific value (Text
Filter). To apply your search criteria select Apply.

There is a scroll bar at the bottom of the Audit Trail page to allow the user to scroll over to columns on the far
right.

13.9 Audit Trail Entries – Examples

 Audit Trail Entries – First time Logging In
Action Audit Trail Entry
Import Feature File Following Feature imported: "[FILE PATH and .LIC FILE NAME] ", registration key:
"[REGISTRATION KEY]", type: "[LICENSE TYPE]",
expiration date: "[N/A or DD-MM-YYYY]", valid: "TRUE", enabled: "TRUE".
Login Failed Because Login failed. Password is expired.
Password Is Expired
Changed Password Changed password.
Open Software EndoScan-V™ Version: [#.#.#], Build Date: [DD-MM-YYYY HH:MM:SS TZD] opened.
Close Software EndoScan-V™ closed.
Incorrect Password Invalid Password: 2 remaining login attempts until EndoScan-V™ account “[LOGIN
Entered NAME]” will be disabled
 Audit Trail Entries – User Management
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 Action Audit Trail Entry
Add new user Added user “[LOGIN NAME]” to the system. Full name = “[FULL NAME]”, Active =
“checked”, Password Expired = “checked”, User Default Password = “checked”.
Add user to a Added user “[LOGIN NAME]” to the privilege group “Administrator”.
privilege group
Add user to sample Added user “[LOGIN NAME]” to the following sample group(s): “All Samples”.
group
Add privileges to a The following privileges were added to the group “Administrator”: “Run Assay, Assay
privilege group Properties, Number of Replicates, Add Disclaimer to All Reports”.
Add new Sample The “CBH Samples” sample group was successfully added with the following
Group sample(s): “SWI”. Users = “N/A”. Description =“my sample group”.
Add new Privilege The “Testing Staff” privilege group was successfully added with the following
Group privileges: xxxxxx
Assign a Signature Building B Lab Manager: privilege group was successfully added with the following
Role privilege(s): “Auto Export and Export File Path, Assay Name Prefix, Assay Name Suffix,
Spike Recovery Range, Include Headers in CSV, Auto Print, Allow Expired Accessories,
Require Comments for Global Settings Changes, Require Comments for Post Assay
Changes, Require Comment on Signature Cancellation, Validation Terminology,
Sample Limit Value Terminology, Run Assay”. Description = “N/A
Delete a User User “TempUser” was successfully deleted.
Delete a Sample The “CBH Samples” sample group was successfully deleted.
Group
Delete a Privilege The “Uber User” privilege group was successfully deleted.
Group
 Settings – Global Settings
Action Audit Trail Entry
Add a file path Changed Database Backup Destination from C:\Program Data to C:\Documents

Check a checkbox Changed “Show Accessories in Report Setting” from

unchecked to ‘checked.
Uncheck a checkbox Changed “Show Accessories in Report Setting” from
“checked” to “unchecked”.
Change value of a Changed “Password Timeout - Days” from “80” to “90”.
field
Add Disclaimer Disclaimer value changed from “N/A” to “Per our NDA”.
Add Logo image Changed logo image from abclogo.png to xyzlogo.png
Change a color value Changed SPL color value from “16711680” to “65280”.
Change to Global Changed Auto Print setting from “Checked” to “Unchecked”. Comments: Print not
Setting with required.
Comments
 Audit Trail Entries – Instruments
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 Action Audit Trail Entry
Add Instrument Instrument “nexgen-PTS™” with serial number 247582 was successfully added to the
software.
Activate an Changed instrument from active to inactive.
instrument
Delete an instrument Instrument “2247582” configured using the computer “MAR-L9X6TTT2” was
successfully deleted.
Deactivate an The active instrument type is changed from BioTekELx808 to nexgen.
instrument
 Audit Trail Entries – Microplate Assay
Action Audit Trail Entry
Assay started Data collection started for “CRL-180511A-20190122-002”.
Assay finished Data collection stopped for “CRL-180511A-20190122-002”.
Added Changed Well: “Crl-180511A-20190122-001” “B2” “Group Name” from “N/A” to
Standard/Spike to “STD1”.
Well
Added Standard to a Changed Well: “CRL-1805111A-20190122-002” “D7” Group Name” from “N/A” to
Well STD1”.
Added Spike to a Well Changed Well: “Crl-1805111A-20190122-002” “D7” Group Name” from “N/A” to
SPK1”.
Post assay change Changed “Standard CV Limit” from “10” to “20” in “CRL-180511A-20190402-002. Post
with comments Assay Comments: CV Limit set incorrectly for assay.
 Audit Trail Entries Digital Signatures
Action Audit Trail Entry
Added new signature Added New signature meaning (“chocolate”) for the role “Quality Control”.
meaning
User validated for Digital Signature validation was successful for “[LOGIN NAME]”.
digital signature
User signed an assay Assay “CRL-16480018-20190122-001-SUF” was digitally signed by “[LOGIN NAME]”
with the role “Analyst”.
User cancelled a Digital Signature cancelled for “CRL-7548-20190401”
signature
User cancelled a Digital Signature cancelled for “CRL-7548-20190401”. Comments: Post assay changes
signature with required so signature cancelled.
comments
 Audit Trail Entries – Accessory Database
Action Audit Trail Entry
Add Accessory Added Accessory - Type: “Cartridge”; Description: “LAL Cartridge”, Product Code: “10
- 0.05”, Lot Number: “9502168”. Calibration Code:”512345678910”, Expiration
Date:”31-Jan-2020 12:00 AM”.
Delete Accessory Deleted Accessory - Type: “Cartridge”; Lot Number:

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 Action Audit Trail Entry
“9502168”; Expiration Date: “31-Jan-2020 12: 00:00 AM”.
Add Accessory Type Added Accessory Type “Copper tubing”.
Delete Accessory Type Deleted Accessory Type “Copper tubing”.
Modify Accessory Modified Accessory Type from “Tubes” to “Tubes 25”.
Type

 Audit Trail Entries – Sample Database

Action Audit Trail Entry
Add Sample Added Sample - Product Family: “WFI”, Sample Name: “Insulin 1077”, Sample ID: “F-
099”, Max. Dosage: “5”, Units: “mL/mL”, Dil/Conc.: “1:1”, Endotoxin Limit: “0.125”,
EU Criteria: “<”, Alert Limit: N/A”, Auto Spike: “Yes”, Spike Conc.: “0.5”, Performed
with: “rCR”, Comments: “Batch 44”.
Modify Modified Sample Name “Insulin 1077”, Sample ID “F-099” Modified
Sample Comments from “Batch 44” to “Batch 55”.
Delete Deleted Accessory - Type: “Cartridge”; Lot Number: “9502168”;
Sample Expiration Date: “31-Jan-2020 12: 00:00 AM”.
Delete Accessory Deleted Accessory Type “Petri dish”.
Type
Modify Accessory Modified Accessory Type from “Tubes” to “Tubes 25”.
Type

14 BACK UP AND RESTORE DATABASE

The Connect/Restore function in the software allows users to connect to a database, and, for specific users or
administrators, to restore. Most users will not have both privileges. For more details on restoring the database, see
Restore Database.

Connect/Restore Window

The Connect/Restore window can be accessed from the login screen under the Settings menu.

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Select Connect/Restore Database, and the following screen is displayed.

14.1 Connect to Database

The following fields are required to be filled in correctly in order to successfully connect.

Database Address is the IP address of the Database. If the database is on the local PC, the Database Address will be
localhost.

Database Port is used to communicate to the database. By default, it is set to the CRL standard of 18083.

When these fields are populated, click the Connect to Database button. The user should then receive a message
saying, Successfully connected to Database, as below.

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If an error has been made, the software will display the following error screen:

If the connection is unsuccessful, the Database Address and Database Port will not be stored, and the fields will be
filled in with the last successful connection Database Address and Database Port, or blank if there has not been a
successful connection yet.

14.2 Backup Database

Backups of all the data in the database should be regularly created. This feature can be set up as a recurring task by
using the Auto-backup feature or can also be created in the moment by simply clicking on the Backup Now button.

Authorized users are granted access to the Global Settings/Security tab.

Then, select the Security tab on the left-hand side, where the Server Backup Details section is found.

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The backup process will be run using the computer account of the system where EndoScan-V™ Services is installed.
If a network share is being used to save the backup data, this computer account must be given access to that
network share.

If a database error occurs with EndoScan-V™ the software will create offline files located in
C:\ProgramData\Charles River\EndoScan-V™\Offline\Audit Trail and C:\
ProgramData\Charles River\EndoScan-V™\Offline\Plate.

Once a database connection is reestablished, the files will then be imported into the database with the correct
timestamps and actions or assays that were performed during the disconnected period. These files are locked
down to the SYSTEM user of the PC and will not be able to be deleted before or after they are successfully
imported.

14.3 Auto-Backup

To enable automatic backups, select Yes from the Backups Enabled drop-down menu.

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In the next box, under Backup Interval – Days, enter the number of days you wish to pass until the next backup is
performed.

The Prefix field can be used to create an identifier to change the default, which is discussed in the Naming
Convention section below.

The time of the Next Backup can be set by clicking the calendar icon in the drop down, as below. The date can be
selected from the calendar, and once the date is selected, the time of day can be manually entered.

Finally, Backup Destination can be established by using the Browse button and navigating to a folder. We
recommend using a network location and a secure folder where the data is protected.

Clicking on the Apply button will commit the backup schedule. Click OK to close the window and return to the main
screen.

14.4 Backup Now

Administrators can choose to make an immediate backup of the database if required. To do this, simply click the
Backup Now button. An immediate backup will be created to the pre-established Backup Destination, using the
filename as in the Naming Convention section below.

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A message will appear in the lower right-hand corner of the screen stating “Starting Database Backup”. Once
completed, if the Global Settings dialog is open a message will appear in the lower right-hand corner stating
“Backup Complete”.

14.5 Restore Database

The Restore Database function will rarely be used, only if a customer had a catastrophic failure and needed to
restore their complete EndoScan-V™ database from a backup.

Restore Database function is only available under the following conditions:

 The Windows user is in the EndoscanAdmins Windows group.

 The Windows user is logged on to the PC where the database is stored.
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  The EndoScan-V™ Services software is installed on the PC.

Charles River recommends performing a Backup of the current database before performing the Restore function.
Once a backup is done, proceed with the Restore as below.

Note: Before performing a restore ensure that no users are logged in to EndoScan-V™. It is also advisable to restart
the Microbial Solutions Database Service prior to the restore process if an error is encountered.

The Restore function is found from the login screen of the software.

Click Settings, then select Connect/Restore Database.

From the next screen, select Browse and the software will open a window where the user can navigate to the
folder where backups are stored.

Select the .tar (backup) file to restore and click Open.

After Restore is clicked, the software will create a backup of the database and then populate it with the file that
was selected for restore.

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Click Yes to restore the database; users will be served a confirmation message, “Database successfully restored
from file “[FILE PATH]”.

Choose No to abort the restore; users will be served a confirmation message, “Database restoration aborted”.

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Any Backup or Restore functions will be noted in the Audit Trail.

Naming Conventions for Backup Files

Different naming conventions will be used to make the backup file type easier to identify by the file name.

If the user has the Scheduled Backup feature turned on, the file name will be created as:

• Prefix_EndoScan-V™ScheduledBackupYYYY-MM-DD_HH-MM-SS
• Example: Prefix_EndoscanVSchduledBackup2019-04-10_15-23-56.tar

If the user initiates a Backup Now function, the file name will be created as:

• Prefix_EndoScan-V™ImmediateBackupYYYY-MM-DD_HH-MM-SS
• Example: Prefix_EndoscanVImmediateBackup2019-04-10_15-23-56.tar

If the user initiated a Restore database call, the file name will be created as:

• Prefix_EndoScan-V™RestoreBackupYYYY-MM-DD_HH-MM-SS

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 • Example: Prefix_EndoscanVRestoreBackup2019-04-10_15-23-56.tar

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