1. ABBOTT PRISM® Retest Server Version 1.1
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ABBOTT PRISM® Retest Server
Version 1.1

2. ABBOTT PRISM® Retest Server, version 1.1
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Content or Pages Revised, Added, or Deleted
10/2006
New Release

3. ABBOTT PRISM® Retest Server
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ABBOTT PRISM® Retest Server
The ABBOTT PRISM Retest Server (APRS) is a computer system capable of transferring and receiving data from multiple ABBOTT PRISM Systems and on-site laboratory computers.
The APRS is an accessory to the ABBOTT PRISM System, designed to provide a common database for sample retest management and report generation for those laboratories with more than one ABBOTT PRISM System.

4. System Function Overview
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System Function
Overview
The ABBOTT PRISM® Retest Server is a computer system that assists laboratories:
To manage the sample retest function for multiple ABBOTT PRISM Systems (up to 8 systems).
To view sample results while the ABBOTT PRISM instrument is processing samples.
To provide a central location to obtain ABBOTT PRISM instrument reports.
To collect, track, and collate test results for each sample tested on the interfaced ABBOTT PRISM instrument(s).
To maintain an audit trail for each interfaced ABBOTT PRISM instrument and ABBOTT PRISM Retest Server.
To determine and communicate sample test requirements based on sample results received from each of the ABBOTT PRISM instrument.
To communicate with an ASTM compatible laboratory computer system to obtain test order information from the laboratory computer system, and to collect test results from the interfaced ABBOTT PRISM instrument.

5. System Function Test Management: View Sample results:
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System Function
Test Management:
The ABBOTT PRISM Retest Server (APRS) manages ABBOTT PRISM test and retest scheduling for all samples statuses across multiple ABBOTT PRISM instruments.
The ABBOTT PRISM Retest Server test recommendations are based on the criteria defined in the ABBOTT PRISM assay-specific package inserts.
NOTE: Overriding of the test recommendations by the operator at either the ABBOTT PRISM instrument or the site laboratory computer may result in processing a different number of replicates other than what is stated in the ABBOTT PRISM assay-specific package inserts.
View Sample results:
The ABBOTT PRISM Retest Server enables the user to view valid sample results while the ABBOTT PRISM instrument is processing samples.
ABBOTT PRISM Reports:
The ABBOTT PRISM Retest Server can print any of the ABBOTT PRISM System Reports , including the Event Log.
Configurable Reports:
The ABBOTT PRISM Retest Server allows the user to create, view, and print configurable sample, controls, and calibration reports using pre-defined options.

6. System Function Workflow
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System Function Workflow

7. System Function Test Scheduling
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System Function Test Scheduling
Test scheduling:
Information can be downloaded from the laboratory computer prior to loading sample racks onto the ABBOTT PRISM instruments.
Definition for each sample ID can be stored in the ABBOTT PRISM Retest Server database.
Test replicate status:
Test replicate status for each ABBOTT PRISM assay type is maintained for every sample ID in the ABBOTT PRISM Retest Server database.
The replicate status is updated when:
Sample results are sent to the ABBOTT PRISM Retest Server.
The testing laboratory overrides the ABBOTT PRISM Retest Server test replicate assignment using the laboratory computer.
The ABBOTT PRISM operator overrides the ABBOTT PRISM Retest Server test replicate assignment using the sample editing option on the ABBOTT PRISM instrument.

8. User Interface – Log-on Screen
System Function
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User Interface – Log-on Screen
Function Menu Options
Show PRISM Status
Show HOST Status
Open HOST Status Info
Open Printer Status

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System Function
The function menu window allows access to the following functions:
Show PRISM Statuses – Click, to show PRISM Port Status(es).
Show HOST Statuses – Click, to show HOST port status(es).
Open HOST Status information – Click, to open the HOST Status Information window, which allows users to resend batches to the host or delete batches.
Resend Procedure:
A Complete Batch (indicated in black) is a batch that was completely received by the APRS, but not completely sent to the host.
A Batch In Process (indicated in green) is a batch that is currently being received by the APRS.
An Incomplete Batch (indicated in red) is a batch that was not completely received from a ABBOTT PRISM instrument.

10. PRISM Port Status Indicators
System Function
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PRISM Port Status Indicators
PRISM port status indicators provide information to the user about the condition of the communication ports that connect the APRS to each ABBOTT PRISM instrument.
PRISM Port
Status Indicators

11. HOST Port Status Indicators
System Function
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HOST Port Status Indicators
HOST port status indicators provide information to the user about the condition of the communication ports that connect the APRS to each laboratory computer.
HOST Port
Status Indicators

12. System Function Status Indicator 1 2 3 4 Place for the logo
Export Status Indicator:
Informs users of the export status.
Backup Status Indicator:
Informs users when to perform a backup.
Archive Status Indicator:
Informs users when to archive and remove data from the APRS based on sample life interval.
Warning Status Indicator:
Notifies users that an event type is a warning.

13. System Function Status Indicator
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System Function Status Indicator
1. Export Status Indicator:
A color change from yellow to green indicates the APRS is exporting results and/or batches.
Double click on the Export Indicator and it displays the Exported Batch Report.
Set the system to automatically export results and/or batches using Configuration.
2. Backup Status Indicator:
A color change from orange to green indicates backup has been performed.
Double click on the Backup Status Indicator and it displays the Backup Preview Batch Report.
Set the time for Backup using Configuration.
3. Archive Status Indicator:
A color change from orange to green indicates an archive has been performed.
Double click on the Archive Status Indicator and it displays the Archive Review Batch Report.
Set up the sample life interval to archive sample using Configuration.
4. Warning Status Indicator:
A color change to orange for an event code type that is a warning.
When an Event report is created, the color of the indicator changes from orange to green.
Double click on the Warning Status Indicator and it displays a Local Events Report showing all event codes types that are warnings.

14. Report PRISM Report Window
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Report PRISM Report Window
The Report tab allows users to access the report
window to create a report.
The PRISM Report Option window pop-ups when
the user selects Create Report. Only one report type can be selected at any one time.
There are various criteria that can be selected for a report, such as:
1. Date Range
2. Sample IDs
3. PRISMs ID Number
4. Report Type
5. Assay
6. Batch 4 3 5 6 2 1

15. Report Configurable Report Window
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Report Configurable Report Window
1. Only Sample, Control and Calibration reports
types are configurable.
2. Different fields can be selected to be included
in the configurable report.
Different criteria can be set under Report Criteria File Manager. The user can save specific created report options with a different report title and comments.
Note: Only one report type can be selected at any one time. 1 2 3

16. Status Local Event Report Window
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Status Local Event Report Window
Refresh
ABBOTT PRISM Retest Server Local Event Reports that occur during APRS operations can be created, viewed and printed by accessing the Status Menu.
Reports are created based on the events in the current database.
To update the database the “Refresh” feature can be selected to provide the user with the most current event log.

17. Status PRISM Event Report Window
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Status PRISM Event Report Window
Refresh
ABBOTT PRISM Events Reports that occur during the ABBOTT PRISM instrument operations can be created, viewed and printed by accessing the Status Tab.
Reports are created based on the events in the current database.
To update the database the “Refresh” feature can be selected to provide the user with the most current event log.

18. Status User Report Window
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Status User Report Window
The User Report provides a list of users that have logged onto the APRS.
The addition or deletion of a user is logged as an event that appears in the Local Event Report.

19. Status PRISM Information Window
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Status PRISM Information Window
The PRISM Information window displays information about each ABBOTT PRISM’s channel and assay status, along with a list of samples that were run on each connected ABBOTT PRISM instrument.

20. Maintenance Database
Archive database: Copies data files from the ABBOTT PRISM Retest Server database to an external storage media or a network drive, and removes the archived data files from the APRS database.
Select and Load Archive database: An existing archived database from a removable storage media or a network drive can be reloaded onto the APRS.
Backup database: Data and system files can be copied from the APRS to a removable storage media or a network drive.
Restore database: Data and system files can be replaced with files from an external storage media or a network drive.
Rebuild database: Optimizes hard drive storage media space by eliminating unused sectors of the database on the hard drive.
Export database: Provides the ability to export ABBOTT PRISM data onto a local network-shared drive and copy to a removable storage media.

21. Maintenance Archive Database Window
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Maintenance Archive Database Window
The color of the Archive Status Indicator turns orange when an archival of data is required.
Batches or sample data are tagged as due for archival according to the archival notification time previously set.
Archive time and storage location for the archive media is set under “Miscellaneous Parameters Window”.
Archive Status Indicator

22. Maintenance Backup Database Window
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Maintenance Backup Database Window
The color of the Backup Status Indicator
turns orange when a backup of data is
required.
Data is tagged as due for backup according
to the backup notification time previously
set.
It is recommended that backup files be
stored using a minimum of 2 Jaz or
CD-R/CD-RW disks, alternating between
the disks.
Backup Status Indicator

23. Maintenance Export Database Window
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Maintenance Export Database Window
To export data the following options are available:
Export database will export data to the shared drive
Copy after the database exported subsection will allow the user to specify a destination to copy data automatically after the export is finished.
Copy exported database from shared location. Data can be selected from the shared drive and copy to a destination of choice.
Delete exported database from shared location. The desired data from the shared drive can be selected and then deleted.
Move exported database from shared location. The desired data from a shared drive can be selected and then moved to a destination of choice.
Export Status Indicator

24. Maintenance Other
Select and Load Archive: Previously archived database can be reloaded on the APRS for report generation.
Restore a database: Existing data on the ABBOTT PRISM Retest Server will be deleted during a restore operation. It is recommended that a printout of the Backup Preview Batch Report be obtained in order to compare with Backed-Up Batch Report. All batches must be re-sent (listed on the Backup Preview Batch Report) from the ABBOTT PRISM instruments that were not restored onto the APRS. The APRS will not accept data from the ABBOTT PRISM instruments or respond to the laboratory computer during a restore operation.
Rebuild a database: Rebuilding the database optimizes hard drive storage media space by eliminating unused sectors of the database on the hard drive. The APRS will not accept data from the ABBOTT PRISM instruments or respond to the laboratory computer during a restore operation.
Incomplete Batches: The maintenance option provide a means to create an Incomplete/Invalid Batch Report. The report provides a list of all the incomplete (non-terminated or invalid) batches currently on the APRS, which need to be resent from an ABBOTT PRISM instrument.

25. Diagnostics Communication
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Diagnostics Communication
The Diagnostics option allows the user to verify communication between the ABBOTT PRISM Retest Server and one or more connected ABBOTT PRISM Instruments.
Communication can also be verified between the Retest Server and a connected laboratory host computer.

26. Configuration Communication
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Configuration Communication
The Configuration option allows:
Setting of the communication parameters of the APRS connected to the ABBOTT PRISM and laboratory computer.
Activation and deactivation of current assays from the ABBOTT PRISM instruments.
Users to be added or deleted, and passwords can be modified.
The user to:
Set the date and time
Select a keyboard
Map a network drive
Disconnect a network drive
Setup a printer
Set other miscellaneous parameters

27. Configuration Assays
Allows users with administrator access to enable/disable existing assays in the database.
New assays are introduced to the database the first time results are sent from the ABBOTT PRISM instrument(s) to the ABBOTT PRISM Retest Server.
The status of each assay in the assay list is configurable to either Active or Inactive.
Grayzones are not accessible for use in U.S. or in FDA licensed facilities outside the U.S.

28. Configuration Users
Users can be added or deleted from the ABBOTT PRISM Retest Server system.
Every user is assigned to a user group where each user group has a pre-configured set of privileges that allow access to certain system function tabs.

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Configuration Setting Miscellaneous Parameters Life of samples/batches, password expiration, and auto logoff settings.
Specifies the number of days that sample and batches can remain in the database without signaling to archive.
Sets the password expiration. The default is 90 days.
Sets the time required before auto logoff. The default is 10 minutes.

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Configuration Setting Miscellaneous Parameters Batch and Group Auto Export Settings
By enabling Batch Exporting On the batch data will be automatically exported at the end of each batch
By enabling Release Group Exporting On sample results will be automatically exported at the end of each release group
Users can now export reports to a CD or mapped network drive (limited to Adobe Acrobat, HTML, and Excel formats)
NOTE: Batch(s) without a release control will not be automatically exported to the shared drive

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Configuration Setting Miscellaneous Parameters Backup and Archive Settings
To change the path to the backup media click on the “B” button to browse/select a new backup drive and path. Default setting is a Jaz Drive (or D Drive).
The number of days for a backup and /or archive notification can be set anywhere from 1 to 60 days.
To change the path to archive media, click on the “A” button to browse/select the new archive drive and path.

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Configuration Setting Miscellaneous Parameters Log Events and Confirmatory Rack Messages
When switch set to Log All Events all APRS events will be displayed in the Local Event Log
When switch set to Log Some Events only fatal errors, warnings, and some informational events will be displayed
When the Confirmatory Rack Data Msg On switch is enabled Confirmatory Rack Data messages will be forwarded from the ABBOTT PRISMs to the Host

33. System Function Communication Interface:
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System Function
Communication Interface:
Users can send batches from the APRS that have not been received by the Host.
A backup of the database can be performed even when the APRS communication ports are busy.
The APRS accepts a PRISM Channel Offline message allowing the user to process samples from the failed channel on a different PRISM instrument.
Miscellaneous Features:
Users have print screen capability using the “F3” or “Print Screen” keys.
Users can display the assay and sample status for each PRISM channel.
The ability to perform a System Shutdown while the communication ports are busy is limited to users with Supervisor level access.
A screen saver is available to disable the monitor image after 20 minutes of inactivity.

34. User Interface – Keyboard functionality
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User Interface – Keyboard functionality
F1 – Help
F2 – Function Popup Menu
F3 – Print Screen
F4 – Exit
F5 – Report
F6 – Status
F7 – Maintenance
F8 – Diagnostics
F9 – Configuration
Print Screen - <F3>
CTRL left arrorw – Move to Left Tab Selection
CTRL right arrow – Move to Right Tab Selection
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