Endosafe nexgen-pts Sw 10.2.2 Users Guide

contents 1 Document Conventions... 1 2 Abbreviations... 1

8.1.1 Types of User Accounts... 5

8.4.1 About Test Reports... 11

8.1.2 Create a New User... 6

8.4.2 View and Print Test Reports... 12

8.1.3 Change the Currently Active User’s Password ... 6

8.4.3 Search for Test Reports... 12

3 Warranty and Service Programs... 1

8.1.4 Reset a Password... 7

8.5 Administration (System Settings)... 13

3.1 Warranty with Purchase... 1

8.1.5 Delete Users... 7

8.5.1 Language... 13

3.2 Service Programs... 1

8.2 Sample Database (for use with Endotoxin and Beta-Glucan Test Cartridges only)... 8

8.5.2 Date and Time... 14

8.2.1 Creating a New Sample ID... 8

8.5.4 Network Configuration... 23

3.3 Additional Information... 1 4 Introduction to the Endosafe® nexgen-PTS™ Instrument... 1

8.2.2 Edit the Sample Database... 8

5 Notification Panel... 2

8.2.4 Loading a Test with the Selected Sample ID... 9

6 Navigation... 3

8.3.1 Inserting a USB Device... 10

7 Keyboards... 4

8.2.3 Deleting a Sample ID... 9 8.3 USB Devices (Data Only)... 10 8.3.2 Saving Log Files to a USB Device... 10 8.3.3 Saving Test Report Files to a USB Device... 11

8 Menu... 5

8.3.4 Updating Software with USB... 11

8.1 User Accounts... 5

8.4 Test Reports... 11

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8.5.3 General Settings... 16 8.5.5 Printer Configuration... 25 8.5.6 Audit Logs... 26 8.5.7 Calibrate Touchscreen... 27 8.5.8 System Information... 27 8.5.9 Shutdown ... 28 9 Troubleshooting... 28

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Document Conventions

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The following conventions are used throughout this document to highlight specific information:

3.1

WARRANTY WITH PURCHASE

For detailed information regarding the warranty of the Endosafe® nexgen-PTS™ instrument, please visit our Terms and Conditions webpage.

Caution – Warns the user that failure to avoid a specific action could result in physical harm to the user or the hardware. Caution – Warns the user of a potential shock situation.

3.2

SERVICE PROGRAMS

For information regarding our service programs for the Endosafe® nexgen-PTS™ instrument, please contact us at [email protected].

Informational – Advises of important information for completing the task.

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Warranty and Service Programs

3.3

Abbreviations

ADDITIONAL INFORMATION

All warranty and service options are subject to the Terms and Conditions specified in the Service Agreement. For answers to questions about any of these components for the Endosafe® nexgen-PTS™ instrument or for additional product information, please contact the Charles River Laboratories Technical Services department:

Abbreviations used in this manual: AP

Access Point

DHCP

Dynamic Host Configuration Protocol

DST

Daylight Saving Time

United States

Europe

EU

Endotoxin Unit (Note: 1 EU is equivalent to 1 IU (International Unit)

FDA

Food and Drug Administration

IP

Internet Protocol

1023 Wappoo Road, Suite 43B Charleston, SC 29407 (843) 402-4900 [email protected]

9 Allée Moulin Berger 69130, Ecully, France 00 800 15 78 97 43 [email protected]

LAL

Limulus Amebocyte Lysate

LAN

Local Area Network

LRW

LAL Reagent Water

MAC address Media Access Control address RGA

Returned Goods Authorization

PDF

Portable Document Format

PTS

Portable Test System

SOP

Standard Operating Procedure(s)

SSID

Service Set Identifier

USB

Universal Serial Bus

Wi-Fi

The standard wireless local area network (WLAN) technology for connecting computers and myriad electronic devices to each other and to the Internet. Only applicable for models equipped with a wireless module.

WLAN

Wireless Local Area Network

WPA-2

Wi-Fi Protected Access 2

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Introduction to the Endosafe nexgen-PTS™ Instrument

®

The Endosafe® nexgen-PTS™ instrument is a rapid, point-of-use handheld spectrophotometer that utilizes disposable cartridges for accurate, convenient, and real-time endotoxin, Gram ID, and Beta-glucan testing. The instrument provides quantitative LAL test results in approximately 15 minutes. For further information pertaining to the instrument, please refer to the Endosafe® nexgen-PTS™ hardware manual. For further information pertaining to the cartridge test procedures please refer to the Endosafe® nexgen-PTS™ assay guides.

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Notification Panel

Power Notifications

This section explains the meanings of the various notifications encountered in the notification panel when using the nexgen-PTS™ instrument.

Description External AC Power icon – Instrument is charging when this icon is displayed. If the External AC Power icon is not displayed, then the instrument is operating on battery power and is not charging.

Notification Panel Screen

Icon

Icon

Description Power notifications will display in the indicated location. See Power Notifications. The Wi-Fi icon will display when a Wi-Fi connection has been set up, provided Wi-Fi is available on the unit. See section 8.5.4.2. The Current Date and Time will display at the top of the screen. See section 8.5.2 for setting date and time.

Battery Power icon green – Battery voltage is sufficient for operation. The Battery Power icon will update during use, displaying a battery power gauge. Battery Power icon red – Battery voltage is low and the instrument should be charged. The Battery Power icon will display a battery power gauge (percent charge remaining) when it gets below 25%. If the AC Power icon is not displayed, then the instrument is operating on battery power and is not charging. The system will notify the user with a prompt that it should be connected to AC power if the level gets below 10%. It will also notify the user once the battery level is so low that the system can no longer run on battery, and will begin a shutdown two minutes after this notification.

The Ethernet icon will display when a wired network connection exists. See section 8.5.4.1. If User Management is On, the currently logged-in user account will display. Temperature of Internal Testing Chamber will update as the internal temperature changes. At initial boot-up of the instrument, the temperature of the internal testing chamber will increase as the instrument warms up.

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Navigation

Instrument Navigation

This section explains the function of the navigation icons.

Button

Menu Screen Navigation Screen

Button

Back – Returns the user to the previous screen. Function Previous Page – Allows the user to navigate to the previous page when multiple pages are available.

Menu – Toggles between the running sample test functions and the main menu functions.

Next Page – Allows the user to navigate to the next page when multiple pages are available.

ABC – Displays the Alpha Characters Keyboard (allows access to Numeric Keyboard and Special Characters Keyboard). 123 – Displays the Numeric Characters Keyboard (123 button will replace the ABC when Alpha Keyboard is launched). Back – Returns the user to the previous screen. Home – Returns the user to the main menu screen.

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Function

Save – Used to save a setting.

(selected) (not selected)

Radio Button – Displays with corresponding text to enable or disable an option or function. When the button is selected, it will display full. When the button is not selected, it will display empty.

The Back button will take you to the previous screen. It may need to also be depressed several times in order to go back to the Main Menu or Insert Cartridge screens.

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Keyboards

Keyboard Symbols

This section explains the keyboards and any special characters the user will encounter when input into an open field is required. The Endosafe® nexgen-PTS™ instrument is configured with an Alpha Characters Keyboard (ABC…), a Numeric Characters Keyboard (123…), and a Special Characters Keyboard (@#$…). The Alpha Characters Keyboard and Numeric Characters Keyboard can be displayed by selecting the corresponding Keyboard button located at the bottom of the screen (indicated by ABC or 123). The Special Characters Keyboard is displayed using the Special Characters Keyboard button (!?) from the Alpha Characters Keyboard.

Keyboards

Clear – Deletes all information typed in a field.

Backspace – Deletes information in a field one character at a time.

Enter – Activates next available field.

Close – Hides the keyboard from view.

Caps – Switches the Alpha Characters Keyboard between all UPPER CASE letters and all lower case letters. Special Characters Keyboard (button) – Switches back to the Special Characters Keyboard when the Alpha Characters Keyboard is active. Alpha Characters Keyboard

Numeric Characters Keyboard

Special Characters Keyboard

Alpha Characters Keyboard (button) – Switches back to the Alpha Characters Keyboard when the Special Characters Keyboard is active.

For most fields, when the field is selected, the instrument will automatically display a keyboard to allow for user input. If the keyboard is not present and it is needed, select the ABC or the 123 button to display the keyboard.

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8

Menu

8.1

This section describes the Menu, functions, and options that are accessible from the Menu. The Menu is accessed by selecting the Menu button at the bottom of the screen.

This section describes how to manage user accounts, how to create user accounts, and instrument accessibility by user account type. To access user accounts, select the User Accounts icon from the Menu screen. User accounts can be set up at any point during instrument setup and/or use of the Endosafe® nexgen-PTS™ instrument.

Menu Screen

Icon

Description

USER ACCOUNTS

The instrument does not come configured with default active users, and does not require user accounts to run a test.

If User Management (requiring log-in, and limiting user access) is required, an initial Administrator account must be created. Once an initial Administrator account is added, User Management can be turned On (see section 8.5.3.1). Additional users can be created before or after the User Management function is turned on.

User Accounts

Sample Database

When User Management is enabled, the name of the currently active user account will display in the notification panel at the top of the screen USB Device

8.1.1 Test Reports

Types of User Accounts

There are three types of user accounts, limiting access as noted when User Management is On (see section 8.5.3.1): Type

Description

User

Allowed to run tests, view test reports, save test reports to a USB device, print data, and load a test from the Sample Database. Has access to the Administration (system settings) page to set up a printer, view the Audit Logs, and view system information. Does not have access to any additional functions, including editing the Sample Database and setting up user accounts.

Manager

Has all of the same access as a User. Additionally, the Manger has full access to the Sample Database and User Accounts screens.

Administrator

By default, an Administrator has access to the complete instrument. If Administrators can run tests is set to No (see section 8.5.3), the Administrator cannot run a test.

Administration (system settings)

Shutdown

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8.1.2

Create a New User

If User Management is On (see section 8.5.3.1), only an Administrator or Manager account can create a new user. 1. Select the Create New User button. 2. Enter a user name in the User Name field. The user name is limited to 11 characters and must have a minimum of 3 characters. 3. Enter a user password in the Password field. If simple passwords are being used, the password must be 3-16 characters of any type. If complex passwords are being used, the password must be 8-16 characters and contain at least one UPPERCASE letter, one lowercase letter, and one number or special character. 4. Re-enter password in the Confirm Password field.

When inputting a password, the frame of the password field will highlight in red if the password does not meet the requirements and/or the passwords in both fields do not match. 5. Select the User Type

8.1.3

Change the Currently Active User’s Password

All user types can change their password. 1. Log in using the user’s current password. 2. Navigate to the Menu, using the Menu icon. 3. Select the User Accounts icon and select the Reset Password button. 4. Enter the user’s current password in the Current Password field. 5. Enter a new user password in the New Password field. The password must be 8-16 characters and contain at least one UPPERCASE letter, one lowercase letter, and one number or special character. 6. Re-enter the new password in the Confirm Password field. 7. Select the Save button to save the new user password.

Select the Show Password radio button to display the password text.

Change the Currently Active User’s Password

6. Select the Save icon to save the new user. Repeat steps 1-6 for additional new users. Create a New User

With User Management On, after 30 minutes of inactivity, the user will need to re-enter their password. The last screen viewed will be displayed; use the Back or Menu buttons to navigate to the Enter Password screen.

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8.1.4

Reset a Password

If User Management is On (see section 8.5.3.1), only an Administrator or Manager account can reset a password for another user; a User can only reset (change) their own password. An Administrator or Manager will follow these steps to reset an Administrator’s password, Manager’s password, or User’s password: 1. On the User Accounts screen, select the user name whose password needs to be reset. (The Previous Page and Next Page buttons can be used to navigate through all users assigned to the instrument.) 2. Select the Edit User button. 3. Select the Reset Password to Default button. 4. The default password will be changed to “pts12345AB”; select OK to confirm.

8.1.5

Delete Users

If User Management is On (see section 8.5.3.1), only an Administrator or Manager account can delete an Administrator, Manager, or User account. 1. On the User Accounts screen, select the user name to be deleted. (The Previous Page and Next Page buttons can be used to navigate through all users assigned to the instrument.) 2. Select the Delete User button. 3. A prompt will display, “Are you sure you want to delete this user?” Press Yes to delete the user, press No to cancel. Deleted users cannot be recovered. (Test reports completed by deleted users will be retained by the instrument.) Delete User

5. The user will be prompted to enter the default password when logging in and then prompted to create a new password. Reset a User’s Password

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8.2

SAMPLE DATABASE

8.2.2

(FOR USE WITH ENDOTOXIN AND BETA-GLUCAN TEST CARTRIDGES ONLY)

If User Management is On (see section 8.5.3.1), only an Administrator or Manager account can edit the Sample Database

This section describes the process for editing, reviewing, and adding information to the Sample (or product) Database. To access the Sample Database, select the Sample Database icon from the Menu screen. The Endosafe® nexgen-PTS™ instrument stores a sample database consisting of Sample ID, Dilution, Endotoxin Limit, and the units. If User Management is On, access to certain Sample Database functions will be limited to Administrator and Manager accounts (see section 8.1.1). All users can view the Sample Database and select sample information with which to load a test. If User Management is On (see section 8.5.3.1), Sample IDs can only be deleted by an Administrator or Manager account (see section 8.1.1).

8.2.1

Edit the Sample Database

1. Select the Sample Database field to edit. (The Previous Page and Next Page buttons can be used to navigate through the Sample Database on the instrument.) 2. Select the Edit Row button. 3. Select the field that needs to be edited: Sample Lot, Dilution, or Endotoxin Limit. (From the drop-down box next to the Dilution field, select mL/mL, L/mL, g/mL, mg/mL, µg/mL, device/mL, or Unit/mL. The Endotoxin Limit will automatically change depending on Dilution units.) 4. Select the Save button when complete. Edit the Sample Database

Creating a New Sample ID

If User Management is On (see section 8.5.3.1), only an Administrator or Manager account can create a new Sample ID in the Sample Database. 1. Select the New Row button. 2. Enter information for the Sample ID. 3. Enter the Dilution, along with the correct units from the drop-down menu. 4. Enter the Endotoxin Limit, if necessary. The units will update based on the Dilution units. 5. Select the Save button when finished. Creating a New Sample ID

When setting up the Sample Database, fields can be left blank, such as Endotoxin Limit. If a field is left blank, the user will need to input the information while running the sample. The only required fields are Sample ID and Dilution.

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8.2.3

Deleting a Sample ID

If User Management is On (see section 8.5.3.1), only an Administrator or Manager account can delete a Sample by Sample ID in the Sample Database. 1. Select the Sample Database field to edit. (The Previous Page and Next Page buttons can be used to navigate through the Sample Database on the instrument.) 2. Select the Delete Selected Row button. 3. A prompt will display, “Are you sure you want to delete this row?” Press Yes to delete the row, press No to cancel. Deleted Sample ID cannot be recovered.

8.2.4

Loading a Test with the Selected Sample ID

All user types can load a test from the Sample Database. 1. Highlight the desired row to load in for the next test. 2. Select the Load Test with Selected Row button. 3. A pop-up box will notify the user that the values from the selected row are loaded for the next test. Press OK. 4. When setting up the next test, the instrument will preload the selected sample information into open fields (please reference applicable assay guide). Loading a Test with the Selected Sample ID

Deleting a Sample ID

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8.3

USB DEVICES (DATA ONLY)

This section describes how to connect a USB device, save log file(s), save test report(s), and update software from a USB device. To access USB devices, select the USB Devices icon from the Menu. All test reports saved to the USB device from the Endosafe® nexgen-PTS™ instrument will be saved as a PDF (Portable Document Format).

To set up a USB printer, see section 8.5.5.

8.3.2

Saving Log Files to a USB Device

If User Management is On (see section 8.5.3.1), only an Administrator or Manager account can save logs to a USB device. 1. Insert the USB device using the USB type A adapter, or directly connect the micro-USB device. 2. Select the device from the Menu. (Buttons for Save Logs to USB, Save Test Reports to USB, and Update Software from USB will be grayed out until a USB device is selected.) Select the Refresh USB Devices button if the device is not displayed. 3. Select Save Logs to USB button.

8.3.1

Saving Log Files to a USB Device

Inserting a USB Device

A USB B micro male device can be directly plugged into the micro-USB (type B) receptacle port on the rear of the instrument. To communicate with standard USB A connections, use the USB type A adapter cable (see Hardware Manual section 4.2) included with the device. Inserting a USB Device

USB B micro male directly-connected device (USB flash drive shown)

USB type A adapter to USB A device (USB flash drive shown)

USB Connector(s)

USB (type A) male connector

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Micro-USB (type B) male connector

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8.3.3

Saving Test Report Files to a USB Device

All user types can save Test Report Files to a USB device. 1. Insert the USB device using the USB type A adapter, or directly connect the USB device. 2. Select Refresh USB Devices button if the device is not displayed. 3. Select the device from the Menu. (Buttons for Save Logs to USB, Save Test Reports to USB, and Update Software from USB will be grayed out until a USB device is selected.) 4. Select Save Test Reports to USB button. Saving Test Report Files to a USB Device

8.4

TEST REPORTS

This section describes the process for accessing, searching, and reviewing reports. The Endosafe® nexgen-PTS™ instrument can store over 10,000 readable reports accessible by users. The instrument stores all test reports that have not been deleted. To access test reports, select the Test Reports icon from the Menu. When saving test reports to USB, see section 8.3.2; for restoring test reports that have been deleted, see section 8.5.3.5).

8.4.1

About Test Reports

All completed test reports are stored on the instrument and will be accessible from the Test Reports screen. At the completion of a test (see assay guides), its report will display. If the results are invalid or do not pass the defined limits, the invalid section(s) of the test will be highlighted in red. Test suitability will fail if any part of the test is invalid or if the endotoxin limit is exceeded. Test Reports

8.3.4

Updating Software with USB Please reference the Installation Instruction guide when updating software versions. “Invalid/Did not pass” endotoxin limit test report

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“Passed” test report

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8.4.2

View and Print Test Reports

8.4.3

Search for Test Reports

All user types can view and print test reports.

All user types can search for test reports.

1. Select a report to view on the screen. (The Previous Page and Next Page buttons can be used to navigate through all test reports on the instrument.)

1. Input the search criteria in the open field at the top of the screen. Use the drop-down at Search by to select the search criteria (Sample ID, Sample Lot, and Date).

2. The report will display the complete results of that test. 3. The complete report can be reviewed by using the Up Arrow and Down Arrow buttons at the top of the screen. 4. If the Graph feature is turned on, the user can elect to show the graph using the Show Graph button.

2. As the search criteria is typed, the instrument will update, showing only test reports that fit the criteria. (The Previous Page and Next Page buttons can be used to navigate through all search results.) Search for Test Reports

5. The user can elect to print the report using the Print Report button to a configured printer. (If the setting requiring a password before printing has been turned on by the Administrator, the user will have to enter their password before printing.) 6. The user can use the Save to USB button to save a PDF copy of the test report to a connected USB storage device. View and Print Test Reports

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8.5

ADMINISTRATION (SYSTEM SETTINGS)

This section describes configurable options available in the Administration page. To access Administration (system settings), select the Administration (system settings) icon from the Menu.

If User Management has been turned On (see section 8.5.3.1), access to certain Administration (system settings) options will be limited by user type (the button will be inaccessible and display gray).

Icon

Administration page 1 (system settings) screen

Description

The Endosafe® nexgen-PTS™ instrument in can be configured to English, French, German, Italian, Spanish, and Portuguese languages. If User Management is On (see section 8.5.3.1), only an Administrator can select the Language icon. 1. Select a language from the list of languages available. 2. Press the Save button. 3. The Administrator will then be prompted to restart the reader to apply changes in the language selected. Select Yes to save and restart, or No to cancel changes.

Icon

Administration page 2 (system settings) screen

Description

Language – Select a language.

Network Configuration – Set up a wired Ethernet or Wi-Fi internet connection.

Date and Time – Configure the date and time.

Printer Configuration – Set up a compatible USB or network printer.

General Settings – Customize system settings and preferences.

Audit Log – Review system audit logs.

Calibrate Touchscreen – Change the calibration of the touchscreen.

System Information – Displays device information (serial number, software version, and temperature calibration date).

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Language

Select a Language

Administration (System Settings)

Menu screen

8.5.1

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8.5.2

Date and Time

Setting the Time

This section describes setting the date and time to the local time zone. To access the date and time settings, select the Date and Time icon from the Administration screen. If User Management is On (see section 8.5.3.1), only an Administrator can select the Date and Time icon.

8.5.2.1 Setting and Adjusting the Time In this screen, the Set Time field will be displayed and set as a 24-hour clock. The time will be displayed on test reports and in instrument logs using a 12-hour clock with AM/PM. The configured time zone will display to the right of the Time Zone button. If the displayed time zone is accurate but the system time needs to be adjusted, go to step 4 of this section. Adjusting the Time 1. Select the Time Zone button. 2. Select the local time zone to adjust the instrument’s time, offset from GMT (Greenwich Mean Time). (The system will automatically adjust the time from the set time to match the indicated time zone.) 3. Select the Save button. 4. To adjust the time: a. Select the Edit button next to the time field. b. To change time by hour, select the Hour field and use the Up and Down Arrows to increase or decrease the time by hour. The Numeric Keyboard can be used to type the correct digit. Highlight the digit to be changed and type in the number. c. To change time by minute, select the Minute field and use the Up and Down Arrows to increase or decrease the time by minute. The Numeric Keyboard can be used to type the correct digit. Highlight the digit to be changed and type in the number. 5. When the time is set, select the Save button. (Save button will be accessible if a change is made.) 6. Time zones are selectable using the Time Zone button. Using the Time Zone button will automatically adjust the time from the set time to match the indicated time zone.

DST (Daylight Saving Time) can be selected to move the time forward one hour during the Daylight Saving Time period.

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8.5.2.2

Setting the Date

8.5.2.3 NTP (Network Time Protocol)

Modification of the date can be completed by selecting the date by day, month, or year and using the arrows to adjust, or using the Calendar icon and calendar pop-up to select a date. 1. Set the date. Date format is displayed YYYY-MM-DD (YYYY = numerical year, MM = numerical month, DD = numerical day).

The displayed time on the instrument can update and set automatically when using a valid NTP server IP address. 1. Select the NTP Settings button. 2. The NTP Settings window will display. 3. To enable NTP, select the On radio button. To disable NTP, select the Off radio button.

a. Select the Edit button next to the time field.

4. Type the NTP server IP address.

b. To change the date by day, select the day field of the screen. Use the Up and Down Arrows to cycle through the days.

5. Select Apply. If a connection cannot be established, an error message will display indicating, “There was an error connecting to the NTP server. Please verify the IP address is correct.”

c. To change the date by month, select the month field of the screen. Use the Up and Down Arrows to cycle through the months. d. To change the date by year, select the year field of the screen. Use the Up and Down Arrows to cycle through the years. 2. To change the date using the calendar, select the Calendar icon. Select the date on the screen and use the OK button to confirm, or Cancel button to disregard the change. Arrows are located at the top of the pop-up to view additional months in the calendar.

6. When NTP is on, the Date and Time screen will display NTP: On. 7. The instrument date and time will update approximately 60 seconds after being configured. Using NTP

3. When the date is set with the arrows or calendar, select the Save button when complete. (Save button will be accessible if a change is made.) Setting the Date

OR

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8.5.3

General Settings

This section defines the general settings that can be configured on the instrument. To access the general settings, select the General Settings icon from the Administration screen. If User Management is On, only an Administrator can select the General Settings icon. When modifying the general settings, select the Save button to save changes. To scroll through the pages of General Settings, press Next Page or Previous Page. The user will be notified by an onscreen prompt that the changes will not take effect until the system is restarted. The user must restart the system at this point to implement the changes. To restart the instrument, select the Shutdown icon from the Menu screen, then restart. General Settings

8.5.3.1 General Settings Page 1 General Settings Page 1 is a selectable page of settings to customize the system. All options are Yes/No or On/Off. When a customized selection is made, select Save prior to navigating away from the General Settings screens. Function

Description/Setting

User Management

On – Enables the requirement of user account(s) for access to the Endosafe® nexgen-PTS™ instrument. An initial Administrator user type must be created to enable this function (see section 8.1). Off – Disables the requirement of user account(s) for access to the Endosafe® nexgen-PTS™ instrument (see section 8.1).

Beep sounds

On – System will audibly sound during a test. Off – System will not make any audible sounds during a test. On – System will emit a short beep after each key press.

Key beep sounds

Endotoxin limit

Off – System will not emit beeps for key presses. On – Allows the user to enter an endotoxin limit for the test. Off – Does not allow the user to enter an endotoxin limit for the test. On – Displays the absorbance graph during the test.

Graph

Off – Does not display the absorbance graph during the test or when viewing past results. On – Will abort the test if “Sample not seen” is reported.

General Settings Screens

Halt on no sample

Halt on sample size error

Sample size detection

Report signature lines

Individual Sample Values

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Off – Will show error message if “Sample not seen” and continue the test. On – Will abort the test if “Sample size too large” or “Sample size too small” are reported. Off – Will show error message if “Sample size too large” or “Sample size too small” and continue the test. On – The user will receive a notification if too much or too little sample is detected. This is primarily a diagnostic tool to help catch pipetting errors. A precise 25 μL aliquot delivery is required into each well for an accurate assay. Off – No notification will be made if too much or too little sample is detected. If no sample is detected, then the user is notified that a sample was not detected in one or more wells. On – Will append signature lines for an Analyst and Reviewer to the end of a printed test report. Off – Will not append signature lines to printed test reports. On – Sample values will be reported individually for each well on the test report. Off – Sample values will be averaged.

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8.5.3.2 General Settings Page 2 (Automatic Network Save Settings)

General Settings Page 2 (Automatic Network Save Settings)

The Automatic Network Save function allows the instrument to be configured to automatically save reports (PDF) to a Windows® Network Share location. This page also contains the setting for automatic printing.

On – The most recent test report will be automatically printed when a test is finished.

Automatic Print

Off – Test reports will not be automatically printed.

Automatic Network Save Settings: 1. To enable the network save location, select the On radio button. To disable the network save function, select the Off radio button. 2. Input the Automatic Network Save Location path into the Automatic Network Save Location field. Reports (PDF) will automatically be sent to the designated location on the network. 3. Select Edit button for the Network User. a. In the open field, input an approved Network User Name with proper permissions to access the Network Save Location. b. Select the Save button. The active Network User will display in the Network User field. 4. Select Edit button for the Network Password. a. In the open field, input the password associated with the previously input user name. b. Select the Save button. The active Network Password hidden character (*) marks will display in the Network Password field. Select the Show Password radio button to display the password text. 5. Select Edit button for the Network Domain. a. In the open field, input the domain associated with the connected network. b. Select the Save button. 6. Select the Save button to save the settings before navigating away from General Settings Page 2 screen.

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8.5.3.3 General Settings Page 3

2.

General Settings Page 3 allows the customization of the User Time Out (amount of time a user is inactive before the instrument will require them to log in again), and provides the option to Clear Users.

Administrators can run tests

Users must enter password before printing test report

Clear Users The Clear Users button, when selected, will remove all users that have been set up in User Accounts (see section 8.1). a. To clear users, select the Clear Users button. b. Dialog box will display, “This will permanently clear all User Accounts. Is this what you want?” i.

On – Administrator users can run tests. Off – Administrator users cannot run tests.

Select Yes to confirm or No to cancel. Selecting Save is not required; when Yes is selected, the User Accounts are removed.

ii. Once the User Accounts are cleared, they cannot be recovered. General Settings Page 3 Clear Users

On – The user is required to enter their password to print test reports. Off – The user is not required to enter their password to print test reports.

Cleared Users cannot be recovered.

1.

Setting User Time Out User Time Out will adjust the amount of time (in minutes) a user can remain inactive before the instrument will log them out (5 minutes to 999 minutes). a. To adjust the amount of time in minutes, select the + (plus) or - (minus) buttons. b. Select the Save button to save the settings before navigating away from General Settings Page 3 screen. General Settings Page 3 User Time Out

3.

Setting Discovery Domain Discovery Domain is a network domain for device discovery. To set the Discovery Domain, select the Edit icon and input the connected network domain. a. Select the Save button. The active Discovery Domain will display in the Discovery Domain field. b. Select the Save button to save the settings before navigating away from General Settings Page 3 screen. General Settings Page 3 Discovery Domain

Setting up Discovery Domain is not currently required. Additional instructions will be provided when the functionality is required. (For Charles River Cortex™ users only.)

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