Ph Azir Setup Utility

PHAZIR Setup Utility™

(MG) Instruction Manual

Version 3.10

PCX13-94-0003 Rev- PSU Manual V3.10

PHAZIR Setup Utility Main Screen

The following is the main screen of PHAZIR Setup Utility. The buttons and functions that areavailable are dependent on the permissions associated with the user account. The PHAZIRRx Software Suite has two pre-defined user accounts named ADMIN and GUEST. TheADMIN account is configured with all permissions. The GUEST account is configured withtypical user permissions.

Both accounts are configured with no password as the default. The password of the ADMINaccount can be added, or modified, but this account cannot be deleted from the PHAZIR.

The following image shows the main PHAZIR page with all options enabled

Only options that are enabled for a given user are displayed on the screen. Options that aredisabled are removed from the PHAZIR’s screen menu. For example, if an operator logs inwith the standard Guest account, the menu items that are disabled do not appear on thescreen.


PHAZIR Setup Utility Basic Configuration

Selecting the Basic Config button leads you to the Basic Config options page.

Enable User Selected Scan Markings: provides a convenient method for users toindicate when bad scans are collected. For example, if a user accidentally pulls the triggerwithout a valid sample being present. To attach a Scan Marking to a record the operatorcan press the down arrow key and select one of the available options. There are two ScanMarking definitions called Mark for Removal and Mark for Comment. A Mark forRemoval Scan Marking can be used to filter out undesirable records.

GMT Timestamps (otherwise local time is used): allows a user with administrativepermission to mark time/date stamps in GMT (Greenwich Mean Time) instead of local time.

Encode Data Files: enables encryption of the PHAZIR Data Files generated andtransferred from the PHAZIR system. When this option is enabled the PHAZIR Data Filesare produced in an encrypted and non-editable format.

Output European CSV Data File: controls the delimiting characters used in PHAZIRoutput data files. If checked the column delimiter is a “;” and the decimal place delimiter is a",". If not checked the column delimiter is a “,” and the decimal place delimiter is a ".".

Logout on Standby: All PHAZIR Methods have a standby setting, which is set in minutes.When the PHAZIR is left idle for a period of time that exceeds this setting, the PHAZIR goesinto standby mode. This turns off the PHAZIR source and, when the Logout on Standby


mode is enabled, the user is automatically logged off the PHAZIR.

Incorrect Login Attempts before ADMIN Login is required: This affects the Loginsecurity of the PHAZIR system. When a user incorrectly logs into the PHAZIR, beyond thisspecified number of attempts, the login function is locked. The ADMIN must successfullylogin to the PHAZIR to restore user access.

Type in UserID (instead of selecting it from a list): This option requires that users key intheir assigned UserID rather than selecting it from a pull down menu.

Idle Minutes before Windows software logs off: This option affects the PHAZIR DataManagement software and the PHAZIR Setup Utility. When either software package is leftidle for a period of time that exceeds this value, in minutes, the user will be automaticallylogged off. This option does not affect PHAZIR operation.

Cancel and Save: The values entered in this menu and all of the menus in PHAZIR SetupUtility must be saved before you return to the main PHAZIR Setup Utility page. If you selectcancel the values will be returned to their previous settings.


PHAZIR Setup Utility User Setup

The User Setup menu is one of the most important functions in PHAZIR Setup Utility. Herethe users with ADMIN (administrator) privileges can establish user accounts and configureuser permissions. An ADMIN and GUEST account are setup as default. Both accounts aresetup without passwords. Passwords can be assigned and modified for both account. TheADMIN account cannot be deleted from the PHAZIR

The table in the above image shows the User ID for each registered account and the accesslevel permissions for PHAZIR Setup Utility, and the PHAZIR Data Management System, andwhether the user has access to the PHAZIR.

To create new accounts you can select either ADD User or ADD Admin. These functionsgenerate new user accounts with either standard Administrative permissions or typical userpermissions.

If Add User is selected the operator is presented with the follow screen with typical defaultuser permissions pre-selected. In this case a new user account named NEWUSER for JSmith was created using the default permissions. The user account may be saved byselecting the Save button.


After saving the User account you can select Cancel to return to the main User Accountscreen. This shows that the NEWUSER account is registered with PHAZIR permission andUser privileges with PHAZIR Setup Utility and PHAZIR Data Management System.

The ADMIN user account is special and cannot be deleted. The Delete user button isdisabled when the ADMIN account is selected to prevent the user account from beingaccidentally deleted. Essential ADMIN user privileges are locked to ensure continuedaccess to ADMIN level permissions for PHAZIR Setup Utility and PHAZIR DataManagement System.


PHAZIR Setup Utility User Settings

There is a limitation on maximum number of characters allowed for USER ID andPasswords. This limit of 10 characters is defined by the software. What is displayed isdetermined by how much physical space characters occupies on the PHAZIR LCD display.Special Wildcard characters like (!@#$%^&*()_+={[}]”’|\:;?/>.~`) are not allowed in User IDand Passwords. First Name and Last Name fields can be upper and/or lower case andspecial characters are allowed.

User ID defines the user Login.

User Enabled can be unchecked to disable the user account.

Require Login if checked, the user will need to apply a password to access the Phazir andPhazirTools. If unchecked, no password is required for access.

Change Password will open a dialog box where the password can be entered. It must beall caps, no spaces or special characters, and must be entered once in each text box.


First Name and Last Name fields are fields that will define the user’s name.

Software Permissions define the user access privileges in the PHAZIR Setup Utility andthe PHAZIR Data Management Software. Privileges can be set to ADMIN (for full access) orUSER (for reduced access), or None (which restricts any access).

Data Signing Level The PHAZIR Rx System supports 21 CFR Part 11 compliance. ThePHAZIR Rx system provides up to four independent signature levels that can be selectedfrom this menu.


PHAZIR Permissions defines the level of access that the USER has to the PHAZIRanalyzer.

Allowed To Use PHAZIR: defines if the user has permission to use any PHAZIR functions.If this checkbox is unselected the user has no access. If the checkbox is selected then thespecific permissions are defined by the sub options below.

Connect on USB: The PHAZIR is interfaced to a PC with a USB connection. If thischeckbox is not selected the USB port will be disabled for the user. The ability of this user totransfer data or configure the PHAZIR Analyzer is prevented.

Select Application: permits the user to select or change the application that is beingperformed by the PHAZIR. If this checkbox is not selected then the user will not be allowedto change applications. If this checkbox is not selected the user will only be able to run thelast used PHAZIR Application.

Select Group ID and Sample Info: The PHAZIR Setup Utility provides a convenient way toconfigure and edit Group ID and Sample Information Fields. If this checkbox is not selectedthe user is not permitted to enter Group ID and Sample Information fields on the PHAZIRanalyzer.

Copy Raw Data to USB: Defines whether the user has access to the PHAZIR diagnosticsfunctions that are generated using the PHAZIR’s Download System Files function. When theDownload System Files function is selected on the PHAZIR a number of diagnostics filesare generated and stored in the PHAZIR/Diagnostics directory including a login audit trail,log file of system calibrations, source life log file.

Calibrate Wavelength: defines whether the user is able to execute the wavelengthcalibration routine on the PHAZIR analyzer. If this checkbox is not selected then the user willnot be allowed to execute the wavelength calibration routine. The user would still be able toperform a wavelength calibration using the PQ function.Delete App Results: Defines whether or not the user has the permission to delete resultdata from the PHAZIR that the loaded application created. Normally it is recommended thata user not be allowed to delete application data.

Perform PQ: Defines whether or not the user has the permission to execute a PQ test. This may be helpful in preventing an untrained user from performing the test accidentally orincorrectly, causing a faliure and preventing the PHAZIR from operating porperly.

Perform OQ: Defines whether or not the user has the permission to execute a OQ test. This may be helpful in preventing an untrained user from performing the test accidentally orincorrectly, causing a faliure and preventing the PHAZIR from operating porperly.Perform Internal Reference Calibration: The microPHAZIR uses an internal referenceflag for background references. It is recommended that this flag be calibrated occasionallyusing an external white reference. This option will be available on a PHAZIR regardless ofthe state of this permission.


Delete All Results: Defines whether or not the user has the permission to delete all resultdata from the PHAZIR regardless of which application created it. Normally it isrecommended that a user not be allowed to delete application data.

Advanced Functions: limits user access from certain advanced functions on the PHAZIRAnalyzer including (1) the ability to set the time and date from the PHAZIR, (2) reset scannumber, and (3) make a restore to factory defaults permanent. Generally it is recommendedthat all users be restricted from accessing these functions and that the user account beconfigured with this checkbox not selected.


PHAZIR Setup Utility Group IDs

Group IDs are a convenient way to record additional information about the samples beinganalyzed. Users can select Set Group ID from the PHAZIR menu system and select from thelist or manually enter information from the PHAZIR keyboard. This information isautomatically stored with subsequent records in the Group ID field. This is particularly usefulwhen spectral data is being collected to generate a qualitative library with PHAZIR MethodGenerator Software. When spectra are imported into the PHAZIR Method Generator theGroup ID field is used to define group member classes. Using the Group ID can simplifyspectral data collection, reduce the need for additional notes, and reduce data entry andtranscription errors.

The area in the red box (above) is a list of Group IDs that can be manually entered usingconventional Windows cut and paste methods. Each row is a separate item, which will bedisplayed on the PHAZIR as separate item in the Group ID list.

List Order: controls how the Group ID list items are arranged. The choices are Static List,which keeps the arrangement of the list items fixed, Recent First, which arranges the GroupID lists so that the most recently used item appears at the top of the list, or Recent Last,which forces the most recently used Group ID to the bottom of the list.

Alphabet (During Edit on PHAZIR): provides a way to define the character set that isavailable if the operator would like to manually enter the Group ID items. Controlling the typeof available characters during editing (letters, numbers, both) and the case (upper andlower) can reduce the number of characters the user must scroll when entering information.Reducing the types of characters to those that are necessary will reduce the amount of timethe user will need to make entries on the PHAZIR keyboard.



PHAZIR Setup Utility Sample Info

Sample Information fields are additional fields where you can store additional informationabout your samples. Sample Information fields are similar to GroupIDs but are only used toprovide additional sample annotations whereas the GroupIDs have specific purposes formember class assignment with the PHAZIR Method Generation software.

In version 2.29 and later the Sample Information categories can be customized by PHAZIRMethod Generation Software. Up to five Sample Information categories are supported. TheSample Information Categories are stored within the PHAZIR Application. The Default PMGSample Field categories are:

In order for a customized Sample Information category to be available to PHAZIR SetupUtility for editing purposes, the corresponding PHAZIR Application must first be added tothe PHAZIR Setup Utility Applications button. This procedure is described in theApplications section. Not every application will use all of the Sample info lists and some listsmay be used by more than one application.


By Selecting the Sample Information field (left) a configuration menu will appear. A sampleInformation list section (right, shown in red) allows you to construct a list by entering each listitem on a separate row. When the operator selects SampleID item the corresponding listwill appear.

When using the PHAZIR, Sample Info fields must be selected prior to a scan, and theselected Sample Info will remain selected for all ofthe following scans until a new selection ismade. The Sample Info fields are stored automatically in the PHAZIR database after eachmeasurement.

List Order: controls how the Group ID list items are arranged. The choices are Static List,which keeps the arrangement of the list items fixed, Recent First, which arranges the GroupID lists so that the most recently used item appears at the top of the list, or Recent Last,which forces the most recently used Group ID to the bottom of the list.

Alphabet (During Edit on PHAZIR): provides a way to define the character set that isavailable if the operator would like to manually enter the Group ID items. Controlling the typeof available characters during editing (letters, numbers, both) and the case (upper andlower) can reduce the number of characters the user must scroll when entering information.Reducing the types of characters to those that are necessary will reduce the amount of timethe user will need to make entries on the PHAZIR keyboard.



PHAZIR Setup Utility Scan Marks

Occasionally when operating the PHAZIR analyzer the operator may accidentally pull thetrigger to start a measurement or the operator may not position the PHAZIR correctlyagainst the sample. The Scan Mark function provides the operator with a method to identifyaccidental measurements. Whereas Sample ID and Group ID must be selected prior to ameasurement, the Scan Marks can be selected subsequent to a measurement.

To configure Scan Marks select Scan Marks from the main menu. You will see the ScanMarks setup page (see below).

There are two Scan Marks, Mark for Removal and Mark as Comment. In addition youmust add a text comment in the fields highlighted in red. Data bearing the Mark forRemoval are flagged in the PHAZIR Data Management Software so they can be filteredout. Data bearing the Mark for Comment are not filtered out.

To enable the Scan Mark function on the PHAZIR analyzer, select the down arrow buttonsubsequent to the measurement. This will present a list box with the defined options listedper the PHAZIR Setup Utility Scan Mark definition.

Note that the Enable User Selected Scan Marking option must also be checked in theBasic Config section of PHAZIR Setup Utility for the scan markings to appear on thePHAZIR. However, this is the default setting.


PHAZIR Setup Utility OQ and PQ

The OQ/PQ function allows the Administrator to configure the PHAZIR’s OperationalQualification (OQ) and Performance Qualification (PQ) tests

The OQ/PQ Monitoring function continuously checks the PHAZIR to ensure that the OQ andPQ tests have been successfully completed within the specified period of time. The OQ testis based on the USP 1119 protocol, which requires two types of traceable standards(wavelength and a set of photometric linearity standards). The PQ test uses a serializedreference standard, which is provided with the PHAZIR as standard feature. The OQ test isintended to be performed during the initial qualification and annually. PQ is performedduring the initial qualification and for short-term verification which can be daily or weekly oreven with each use.

If the OQ/PQ Monitor is enabled the PHAZIR will continuously monitor the expiration statusof the PHAZIR. When enabled the OQ & PQ expiration and warning period must be defined.In version 2.29 and later the OQ & PQ Monitoring functions can be enabled/disabledindependently from one another.

The default values are as follows:

PQ Expires: 24 hours

PQ Warning: 20 hours

OQ Expires: 730 Days

OQ Warning: 725 Days

An OQ/PQ Monitor icon is displayed on the PHAZIR’s color LCD display for each test. Theicon is in the form of a colored oval with the letters "OQ" or "PQ". The oval is color coded asfollows:

Green = OQ or PQ tests have passed within the specified period of time


Red = OQ and/or PQ tests have expired. These tests must be successfully passed beforecontinuing use of the PHAZIR. Data taken after OQ or PQ expiration will be automaticallymarked for deletion.

White w/ Red “X” = OQ and/or PQ tests have failed. These tests must be successfullypassed before continuing use of the PHAZIR. Only the OQ and PQ applications will beallowed to run until the failed test has been passed.

Yellow = OQ and/or PQ test are close to the expiration period. The system is ready for usebut preparations for re-qualification should be made.

OQ / PQ Settings are values associated with the certified values of the 4 NIR traceablephotometric standards that are used to test the PHAZIR’s photometric linearity and noiseaccording to the USP 1119 NIR protocol. A NIR traceable wavelength standard is used totest the PHAZIR’s wavelength accuracy according to the USP 1119 NIR protocol.

The 2% Standard, 10% Standard, 40% Standard, and 99% Standard values must beset to the corresponding standards that will be used in the PHAZIR testing. The CalibrationWL (Calibration Wavelength) value defines the reference peak that will be used for thewavelength accuracy testing according to the USP NIR protocol. The Linearity WL(Linearity Wavelength) value defines the wavelength over which the photometric linearity willbe tested.

The Advanced button displays the acceptance criteria for the USP 1119 OQ andPolychromix PQ test routines. These acceptance criteria are predefined in the USP 1119and Polychromix documentation and generally do not require adjustment. Note theAdvanced parameters are only displayed and available to users with Admin privileges.

*See the USP 1119 Chapter of the PHAZIR Rx IQ/OQ/PQ manual for more detailedinformation related to the USP 1119 test protocol.


PHAZIR Setup Utility Applications

The Applications function assist the administrator in managing applications stored on thePHAZIR.

You can add applications by selecting the Add/Replace button, which will allow you tobrowse your computer for PHAZIR applications. Applications can be enabled or disabledwith the Active/ScriptName check box.


PHAZIR Setup Utility Languages

This function allows for System messages on the PHAZIR to be displayed in a languageother than English. Once the user selects a language from the list of Languages, as shownbelow, and performs a Config PHAZIR, then PHAZIR will restart and begin displayingmessages in the chosen language.

English, German, Hungarian, and Spanish are installed with PHAZIRTools 2.30 andlater. The User can add a new Language by pressing the Add button, or edit any of themessage translations in one of the included Languages by selecting the desired Languageand pressing Edit.

The Edit window, as shown below, allows for the user to alter an existing translation add anew message to be translated, or remove a message, causing it to be shown in English. PHAZIR Messages appear on the left column and should appear exactly as they do on thePHAZIR, capitalization, spaces, and punctuation is important. The translation for eachPHAZIR Message into the chosen language appears in the right column. Any PHAZIRMessage or Translated message may be edited directly by clicking in a selected row andtyping.

Save applys any changes made to the PHAZIR messages and Translated messages.

Delete removes the selected row, this will cause that PHAZIR Message to appear inEnglish on the PHAZIR.


Save to File will export all of the PHAZIR messages and their translations to a csv file. Thisfile can then be viewed in Excel or imported in another installation, but only if the correctformatting is preserved. It is recommended that the translations be edited within PHAZIRSetup Utility and that the Save to File function is only used as a means of sharingtranslations amoung multiple installations.

Import will attempt to import a csv file that has previously been created in PHAZIR SetupUtility.

Continue exits the Language translation editing window.


PHAZIR Setup Utility Config PHAZIR

The Config PHAZIR function manages uploading PHAZIR Setup Utility configurations ontothe PHAZIR Analyzer. In order for settings within the PHAZIR Setup Utility to become activethe PHAZIR must be synchronized.

The synchronization process is automated and the user only needs to plug in the USB cableand press one button.

Selecting Configure PHAZIR(s) starts the synchronization process.

When the USB cable is disconnected the PHAZIR will restart and load the new configurationwith the new settings. This process takes less than 30 seconds.


PHAZIR Setup Utility About

This function display the current version number of the software package


PHAZIR Setup Utility Exit

This function exits the PHAZIR Setup Utility software.

The PHAZIR Setup Utility and PHAZIR Data Management System software cannot beoperated at the same time. The operator must exit and log out of one package prior tostarting and logging into the other.

If the operator attempts to open one of the software packages while the other is running, theoperator will be prompted. If Yes is select the active package will be closed and the othersoftware package will be started. The operator must log in each time the software isstarted.


Ph Azir Setup Utility

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