Health Reports

Scope

The Panther Dashboard software contains new functionality for generating Health Reports for the Panther System. The three Health Reports that are part of the Panther Dashboard software are:

• The One-Day Health Report
• The Panther (System) Health Report
• The System Health Report

Health Report Sections

Software Version(s)

System History with the software installation dates and software version numbers.

Firmware Version(s)

System History with the firmware installation dates and firmware version numbers.

Installed Assay(s)

The Installed AssayProcedures required to prepare and perform a specific test. In the context of this document, assay refers exclusively to a Hologic test, such as Aptima Combo or Ultrio.(s) version numbers and their installation dates.

System Statistics

Statistics of the System: Uptime, Number of Restarts, and Number of Fatal Errors that occurred since the previously generated report.

Assay Test Order Count

Assay types that ran on the system and the total number of assays executed over the duration of the report.

Rate of Invalids

Statistics of the System: Number of Tests, Number of Invalids, and Rate of Invalids that occurred since the previously generated report.

Total Test Orders with Flags

The number of test orders attempted on the system with the percentage of samples flagged during the interval of the report generated.

Test Orders with Single Flags

The number of test orders released with a single flag and the corresponding percentage.

Test Orders with Multiple Flags

The number of times this specific confirmation of flags occurred over the time interval of the report generated.

Flags By Module

The number of flags that occurred per system module.

Notable Events

A Subset of events that occurred during system activity and message log events filtered for system critical events: I.E. PrimeOperation of pumping fluid through tubing to ensure proper and consistent fluid delivery (remove air from the tubing, etc.)., Hardware Failures, Non Fatal Hardware Events, and Issues.

Event Numbers for Modules, SubModules

Event Numbers per SubModule when:

• Message—Green text
• Warning—Orange text
• Critical—Red text
• Fatal—Red background with black text

Threshold Table—Lumo and Output Queue

Air/Liquid Threshold values determined during the Luminometer/Output OLV sensor calibration performed during prime.

MagWash Table

Commands	Description	Details
34	Tip Pick	Confirmed tiplet is picked at the beginning of the Magnetic Wash process
45	Wash Volume Verify	Occurs after wash dispense
46	Residual Wash Check	Occurs at the end of the Magnetic Wash process to verify the MTUMulti-tube unit—Container used to process tests in the instrument. An MTU contains five separate reaction tubes. The MTU is moved through the instrument by the linear distributor and includes five tiplets for pipettiing to be used in the mag wash station. is empty
51	Tip Still On	TipletDisposable tip within an MTU. check to verify the tiplet is on during Magnetic Wash processing
35	Tip Strip	Stripping of the tip at the end of the process
47	Empty Check (PRIME)	Verify the MTU is empty at the end of the Prime

Flags

A subset of Assay Processing Codes "Flags" and generates the process control graphs of interest for particular flags.

Sensor Readings

Temperature and Vacuum measurements per module over the duration of the report.

Health Report Summary

	One-Day Health Report	System Health Report	Panther (System) Health Report
For Technical Support Use	X	N/A	X
For Field Service Use	X	N/A	X
For Marketing Use	X	X	N/A
Software Version(s)	X	X	X
Firmware Version(s)	X	X	X
Installed Assay(s)	X	X	X
System Statistics	X	X	X
Assay Test Order Count	X	X	X
Rate of Invalids	X	X	X
Total Test Orders with Flags	X	X	X
Test Orders with Single Flags	X	X	X
Test Orders with Multiple Flags	X	X	X
Flags by Module	X	N/A	X
Notable Events	X	N/A	X
Module to Severity Level Break Down	X	N/A	X
Event Numbers for Modules, SubModules	X	N/A	X
Threshold Table—Lumo and Output Queue	X	N/A	X
MagWash Table	X	N/A	X
Flags	X	N/A	N/A
Sensor Readings	X	N/A	N/A

Send Logs

	One-Day Health Report	System Health Report	Panther (System) Health Report
Report is created if less than 32 hours has elapsed from the previously generated report	X	N/A	N/A
Report is created if greater than 32 hours has elapsed from the previously produced report	N/A	N/A	X