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HOLOGIC PANTHER SYSTEM OPERATOR'S

MANUAL

Table of Contents
Revision History
Table of Contents
Table of Contents
List of Figures
Welcome to the Panther® System
Description and Intended Use
Using this Manual
Intended Reader
What This Manual Covers
Typographical Conventions
Safety Symbols
Terminology
Special Terminology
Acronyms/Abbreviations
Compliance and Safety
Compliance
Electromagnetic Compatibility
Safety
Panther System Warnings
System Handling Warnings
System Environment Warnings
System Configuration Warnings
Sample Handling Warnings
Consumable, Reagent, and Fluid Warnings
Consumable Warnings
Reagent Warnings
Fluid Warnings
Biological and Chemical Hazards
Electrical and Mechanical Hazards
Glove Usage Recommendations
Limitations
Table 1. Changing Gloves
Specifications and Requirements
Physical Specifications
Environmental Requirements
Table 2. Size and Weight Specifications
Table 3. Clearance Specifications
Table 4. Environmental Requirements
Power Requirements
Table 5. Environmental Output
Table 6. Power Requirements
Internal Specifications
Table 7. Internal Specifications
Sample Tube Specifications
Sample Tube Barcode Requirements
Table 8. Sample Tube Requirements
Table 9. Barcode Requirements
Figure 1. Sample Tube Barcode Label Requirements
Sample Requirements
Volume Requirements
Table 10. Allowable Barcode Characters
Table 11. Panther System Volume Requirements
Dead Space Volume Requirements
System Capacities and Throughput
Table 12. Panther System Dead Space Volume Requirements
Table 13. System Capacities and Throughput
Operator Prerequisites
Overview
Technology Overview
Target Capture
Figure 2. Target Capture
Transcription-Mediated Amplification (TMA)
Hybridization Protection Assay (HPA)
Figure 3. Hybridization Protection Assay
Dual Kinetic Assay (DKA)
Real-Time Assays
Internal Controls for Aptima Assays
Panther System Overview
Introduction
Instrument Overview
Figure 4. Panther System
Table 14. Panther System Components
Canopy
Figure 5. Canopy
Table 15. Canopy Location Descriptions
Panther Upper Bay Components
Figure 6. Panther Upper Bay
Table 16. Panther Upper Bay Descriptions
Reagent Bay
Figure 7. Reagent Bay
Panther Tip Drawer Module
Sample Bay Module
Target Capture Reagent (TCR) Carousel
Figure 8. Sample Bay Module
Panther Pipettor System
Fluid Pumps
Panther Mid Bay Components
Figure 9. Panther Pipettor System
Figure 10. Panther Mid Bay
Table 17. Panther Mid Bay Descriptions
Incubators
MTU Input Queue
Distributor
AMP Load Station
HPA Load Station
Magnetic Wash Module
Sample Mix Station
Luminometer
Output Queue
Panther Lower Bay Components
Figure 11. Panther Lower Bay
Table 18. Panther Lower Bay Descriptions
Computer
Panther Waste Drawer
Liquid Waste Container
Solid Waste Container
Panther Universal Fluids Drawer
NaOCl Bottle
Vacuum Pump
Printer
Panther System Software Overview
Introduction
Accessing the Panther System Software
Desktop Shield
Figure 12. Desktop Shield Screen (Example)
Login Screen
Navigating the Software
Figure 13. Login Screen (Example)
Table 19. Login Screen Interactive Item Descriptions
Figure 14. Screen Locations (Example)
Table 20. Universal Screen Interactive Item Descriptions
Menu Bar
Interactive Items
Figure 15. Menu Bar (Example)
Table 21. Menu Button Descriptions
Table 22. Interactive Item Descriptions
Selection Button
Status Panel
Figure 16. Row Selection Menu (Example)
Table 23. Row Selection Menu Buttons
Status Panel Bars
Figure 17. Status Panel (Example)
Table 24. Status Bar Updates
Additional Status Panel Icons
Table 25. Additional Status Icon Descriptions
Additional Status Panel Items
Table 26. Additional Status Panel Items
Panther System Software Screens
Desktop Shield Screen
Figure 18. Desktop Shield Screen (Example)
Table 27. Desktop Shield Screen Button Descriptions
Messages Screen
Figure 19. Messages Screen (Example)
Table 28. Message Screen Descriptions
Comments Screen
Pending Screen
Figure 20. Comments Screen (Example)
Table 29. Comments Screen Descriptions
Tasks Screen
Figure 21. Pending Screen (Example)
Figure 22. Tasks Screen (Example)
Table 30. Tasks Screen Buttons
Universal Fluid Bay Screen
Waste Management Screen
Figure 23. Universal Fluid Bay Screen (Example)
Table 31. Universal Fluid Bay Screen Descriptions
Maintenance Activities Screen
Figure 24. Waste Management Screen (Example)
Table 32. Waste Management Screen Descriptions
Figure 25. Maintenance Activities Screen (Example)
Table 33. Maintenance Activities Screen Descriptions
Assay Reagent Bay Screen
Figure 26. Assay Reagent Bay Screen (Example)
Assay Reagent Loading Screen
Table 34. Assay Reagent Bay Screen Descriptions
Sample Rack Bay Screen
Figure 27. Assay Reagent Loading Screen (Example)
Table 35. Assay Reagent Loading Screen Descriptions
Figure 28. Sample Rack Bay Screen (Example)
Table 36. Sample Rack Bay Screen Descriptions
Sample Rack Loading Screen
Figure 29. Sample Rack Loading Screen (Example)
Table 37. Sample Rack Loading Screen Descriptions
Sample Details Screen
Figure 30. Sample Details Screen (Example)
Table 38. Sample Details Screen Descriptions
Run Status Screen
Figure 31. Run Status Screen (Example)
Table 39. Run Status Screen Descriptions
Test Orders Screen
Figure 32. Test Orders Screen (Example)
Results Screen
Figure 33. Results Screen (Example)
Table 40. Test Orders Screen Descriptions
Table 41. Results Screen Descriptions
Report Menu Screen
Figure 34. Report Menu Screen (Example)
Table 42. Report Menu Screen Descriptions
Administration Screen
Figure 35. Administration Screen (Example)
Table 43. Administration Screen Button Descriptions
Data Management Screen
Figure 36. Data Management Screen (Example)
Table 44. Data Management Screen Button Descriptions
System Configuration Screen
Figure 37. System Configuration Screen (Expanded Example)
LIS Configuration Screen
Table 45. System Configuration Screen Descriptions
Figure 38. LIS Configuration Screen-General Settings (Example)
Figure 39. LIS Configuration Screen-Serial Settings (Example)
Figure 40. LIS Configuration Screen-TCP/IP Settings (Example)
Figure 41. LIS Configuration Screen-File Settings (Example)
Table 46. LIS Configuration Screen Location Descriptions
Operator Management Screen
Change Password
Figure 42. Operator Management Screen (Example)
Table 47. Operator Management Screen Location Descriptions
Quality Control Configuration Screen
Figure 43. Quality Control Configuration Screen-External Quality
Controls Tab (Example)
Table 48. Quality Control Configuration Screen Button Descriptions
(External Quality Controls Tab)
Reflex Testing Configuration Screen
Figure 44. Quality Control Configuration Screen-Manufacturer's
Controls/Calibrators Tab (Example)
Table 49. Quality Control Configuration Screen Button Descriptions
(Manufacturer's Controls/Calibrators Tab)
Figure 45. Reflex Testing Configuration Screen (Example)
Table 50. Reflex Testing Configuration Screen Button Descriptions
Assay Custom Cutoff Value Configuration Screen
Help Window
Figure 46. Help Window (Example)
Table 51. Help Window Buttons
Logoff/Shutdown Screen
Figure 47. Logoff/Shutdown Screen (Example)
Table 52. Logoff/Shutdown Screen Buttons
System Operation
System Startup
Login/Logoff
Login
Logoff
System Operation
Load Tips
Figure 48. Tasks Screen (Example)
Figure 49. Tip Loading Management Window (Example)
Table 53. Tip Replacement Options
Load MTUs
Load Universal Fluids
Load Panther Universal Fluids
Replace Panther Universal Fluids
Figure 50. Bottle Status Panel (Example)
Empty Waste
Empty Waste-Warnings
Emptying Panther Waste
Figure 51. Disposing of Liquid Waste Container Contents (Example)
Perform Maintenance
Prime Instrument
Figure 52. Maintenance Activities Screen (Example)
Prime Criteria
Table 54. System Prime Resource Consumption
Prime Procedure
Force Full Prime
Load Panther Assay Reagents
Master Lot Setup
Add a New Master Lot
Figure 53. New/Activate Master Log Screen (Example)
Inactivate a Master Lot
Reactivate a Master Lot
Figure 54. Inactivate Master Lot Window (Example)
Reagent Kit Date Extension
Loading Panther Assay Reagents into Racks
Figure 55. Panther Reagent Rack (Example)
Loading Panther Assay Reagents
Figure 56. Supplemental Reagent Information Window (Example)
Unloading Panther Assay Reagents
Figure 57. Supplemental Reagent Information Window-Redundant
Lots (Example)
Load Samples
Adding a New Control/Calibrator Lot
Controls/Calibrators Setup
Figure 58. Control/Calibrator Lot Entry Screen (Example)
Figure 59. Sample Rack Bay Screen (Example)
Control/Calibrator Processing
Run New Controls/Calibrators
Loading Samples into Sample Racks
Sample Defaults
Adding an Assay to the Sample Defaults
Figure 60. Panther Sample Rack-With Retainer
Altering Replicate Count for Sample Defaults
Figure 61. Sample Defaults Window (Example)
Deleting an Assay Test from the Sample Defaults
Configuring Additional Sample Defaults
Figure 62. Expanded Sample Defaults Window (Example)
Table 55. Additional Sample Default Options
Manually Download Test Orders
Loading Sample Racks
Load Sample Racks into the Sample Bay
Assigning a Reagent Lane for Aptima Assays
Figure 63. Select Reagent Lanes Window (Example)
Editing Specimen Test Orders
Adding a Test Order
Figure 64. Add Test Orders Window (Example)
Deleting a Test Order
Scheduling STAT Test Orders
Running Controls/Calibrators as Specimens
Dilution Factors
Figure 65. Process as Specimen Checkbox (Example)
Apply Dilution Factors
Delete Dilution Factors
Unloading Sample Racks
Initiating Assay Processing
Pausing Sample Pipetting
Resume Pipetting Following Pause
Monitoring the System through Hardware
System LEDs
Reagent Bay Lane LEDs
Table 56. System LED Status Color Legend
Table 57. Reagent Bay Lane LED Status Color Legend
Sample Bay Lane LEDs
Tip Drawer, TCR Door, and MTU Input Queue LEDs
Table 58. Sample Bay Lane LED Status Color Legend
Table 59. Tip Drawer, TCR Door, and MTU Input Queue LED Status
Color Legend
System Alarm
Monitoring the System through Software
Monitoring the Menu Bar
Table 60. Menu Bar Status Descriptions
Monitoring the State Indicator
Table 61. System State Indicators
Monitoring the Status Panel
Status Panel
Status Panel Bars
Figure 66. Status Panel (Example)
Table 62. Status Bar Updates
System Activity Updates
Additional Status Panel Icons
Table 63. Status Icon Descriptions
Monitoring Pending Tasks
Monitoring Reagent Status
Panther Assay Reagent Bay Screen
Figure 67. Temperatures and Sensors Screen (Example)
Assay Reagent Loading Screen
Table 64. Reagent Rack Status Color Legend
Table 65. Assay Reagent Status Color Legend
Run Status Screen
Monitoring Test Orders
Figure 68. Assay Reagent Loading Screen (Example)
Figure 69. Assay Reagents Panel (Example)
Viewing Test Orders
Test Order Status
Figure 70. Test Orders Screen (Example)
Table 66. Test Order Screen Fields
Monitoring Loaded Specimen Status
Sample Rack Bay Screen
Table 67. Test Order Status Definitions
Table 68. Sample Rack Status Color Legend
Run Status Screen
Specimen Status
Figure 71. Run Status Screen (Example)
Figure 72. Sample Status Locations (Example)
Table 69. Specimen Status Definitions
Specimens Panel
Figure 73. Specimens Loaded Panel-Without LIS (Example)
Monitoring Control/Calibrator Status
Assay Reagents Panel
Figure 74. Specimens Loaded Panel-With LIS (Example)
Table 70. Control/Calibrator Status Definitions
Monitoring Results Timing
Results Management
Viewing Results
Figure 75. Assay Reagents Panel (Example)
Figure 76. Results Panel (Example)
Results Information
Figure 77. Results Screen-Expanded (Example)
Sample Curve Report
Figure 78. Sample Curve Report (Example)
Result Details
User Comment
Filter Results
Verifying Results
Editing Auto-Generated or Manually Entered Sample IDs
Figure 79. Results Screen with Filters Panel (Example)
Data Export
Exporting to a USB Flash Drive
Removal of a USB Flash Drive
Figure 80. USB Storage Removal Window (Example)
Exporting Raw Data
Exporting LIS Data
Sending Results to LIS
Export Viral Data
Reports Management
Table 71. Reports
Selecting Reports
Figure 81. Report Parameters for Results Report (Example)
Navigating Reports
Printing Reports
Figure 82. Panther System Report Navigation Bar
Table 72. Report Navigation Buttons
Exporting Reports
Reports
Activity Log Report
Assay Reagent Report
Figure 83. Activity Log Report (Example)
Table 73. Activity Log Report-Report Parameters
Configuration Report
Figure 84. Assay Reagent Report (Example)
Table 74. Assay Reagent Report-Report Parameters
Diagnostics Log Report
Figure 85. Configuration Report (Example)
Table 75. Diagnostics Log Report-Report Parameters
Exceptions by Worklist Report
Figure 86. Diagnostics Log Report (Example)
Table 76. Exceptions by Worklist Report-Report Parameters
Exceptions Report
Figure 87. Exceptions by Worklist Report (Example)
Table 77. Exceptions Report-Report Parameters
Levey-Jennings Report
Figure 88. Exceptions Report (Example)
Table 78. Levey-Jennings Report-Report Parameters
Lot Search Report
Figure 89. Levey-Jennings Report (Example)
Maintenance Checklist
Figure 90. Lot Search Report (Example)
Table 79. Lot Search Report-Report Parameters
Maintenance Log Report
Figure 91. Maintenance Checklist (Example)
Table 80. Maintenance Checklist -Report Parameters
Messages Log Report
Figure 92. Maintenance Log (Example)
Table 81. Maintenance Log Report-Report Parameters
Table 82. Messages Log Report-Report Parameters
Prevalence Report
Figure 93. Messages Log Report (Example)
Table 83. Prevalence Report-Report Parameters
Results by Worklist Report
Figure 94. Prevalence Report (Example)
Table 84. Results by Worklist Report-Report Parameters
Results Report
Figure 95. Results by Worklist Report (Example)
Table 85. Results Report-Report Parameters
Sample Audit Report
Figure 96. Results Report (Example)
Table 86. Sample Audit Report-Report Parameters
Test Count Report
Figure 97. Sample Audit Report (Example)
Table 87. Test Count Report-Report Parameters
Worklist Lot Report
Figure 98. Test Count Report (Example)
Table 88. Worklist Lot Report-Report Parameters
System Shutdown
Figure 99. Worklist Lot Report (Example)
Figure 100. Shutdown Confirmation Window
Maintenance
General Maintenance Information
Maintenance Task Summary
Table 89. Maintenance Task Summary
Maintenance Activities Screen
Maintenance Task Details Screen
Figure 101. Maintenance Activities Screen (Example)
Set Maintenance Tasks to Required
Figure 102. Maintenance Task Details Screen-Clean Sample Shield
(Example)
Schedule an Automated Maintenance Task
Figure 103. Edit Maintenance Task Screen Mag Wash Cleaning
(Example)
Tracking the Maintenance Schedule
Figure 104. Scheduled For Automated Start Panel (Example)
Figure 105. Maintenance Table (Example)
Maintenance Reports
Record Maintenance Comments
Recommended Cleaning Agents
Figure 106. Maintenance Task Completed Screen (Example)
Table 90. Recommended Cleaning Agents
Preparing Sodium Hypochlorite Solution
Preparing Bleach Enhancer Solution
Laboratory Check and Cleaning
Table 91. Environmental Specifications
Preparing a Clean Workspace
Clean with Sodium Hypochlorite Solution
Clean with Prepared Bleach Enhancer Solution (if applicable)
Checking for Leaks and Spills
Mag Wash Clean
Table 92. Example Mag Wash Maintenance Tasks Cleaning
Schedules
Clean the Sample Shield
Table 93. Mag Wash Cleaning Inventory
PC Reboot Maintenance
Monthly Maintenance
Step 1. Clean the Monitor and Scanner
Step 2. Clean the Tip Drawers
Step 3. Clean the Reagent Bay
Step 4. Clean the Sample Bay
Step 5. Clean the Panther Universal Fluid Drawer
Step 6. Clean the Panther Waste Drawer
Figure 107. Disposing of Liquid Waste Container Contents
(Example)
Step 7. Clean the External Surfaces
Replace Mag Wash Cleaning Solution
Idle Maintenance
Table 94. Idle Maintenance Procedures
Clean Sample Racks and Reagent Racks
Database Maintenance
Database Backup
Database Restore
Delete Database
System Administration
Specimen Processing Modes
Random Access Loading-Bidirectional LIS Host Query
Manual Download
Automatic Host Query
Batch Loading
Samples with Barcodes
Samples without Barcodes
Database Administration
Auto Purge Log Configuration
Purge Logs
Purge Results
Configuration
Figure 108. Purge Results Window (Example)
User Interface
Table 95. User Interface Options
Enable Automatic Log Off
Threshold Management
Waste Threshold
Table 96. Threshold Management Options
Universal Fluid Management
Table 97. Universal Fluid Management Options
Priming Management
Enable Automatic Priming
Table 98. Priming Management Options
Assay Reagent Loading
Default Reconstitution Date Selection
Figure 109. Assay Reagent Loading Window (Example)
Table 99. Assay Reagent Loading Options
Specimen Loading
Table 100. Specimen Loading Options
Enable Non-Barcode Sample Loading
Enable Auto Sample ID Assignment
Enable Detection and Flagging of Repeat Barcodes/Reject All
Repeat Test Orders
Manual Barcode Entry Mode
Enable Worklist ID Suffix
Table 101. Manual Barcode Entry Modes
ISBT128 Barcodes Enabled
Results Management
Enable RLU Value Suppression for Aptima Combo
Table 102. ISBT128 Barcodes Stripping Options
Table 103. Results Management Options
Panther Calibrator and/or Control Frequency
Report Management
Enable Temperature Check Reporting
Report Export Directory
Table 104. Report Management Options
Data Export Management
Delimiter Character for Export Files
Table 105. Data Export Management Options
Raw Data Export Directory
Security Management
Figure 110. Delimiter Character for Export Files Window
Table 106. Security Management Options
Cybersecurity and Data Protection
Power Save Management
Table 107. Power Save Management Options
Enable Power Save Mode
Time to End Power Save Mode
UPS Management
Printer Management
Default Printer Name
Table 108. UPS Management Setting Options
Table 109. Printer Settings Options
LIS Configuration
Table 110. LIS Configuration Options
Enable LIS Connection
Disable the LIS Connection
Enable Automatic Results Holding
LIS Messages
Operator Management
Enable/Disable Operator Accounts
Adding Operator Accounts
Table 111. Operator Management Options
Figure 112. Add Operator Window (Example)
Editing Operator Accounts
Table 112. Operator Roles
Deleting Operator Accounts
Change Password
Figure 113. Edit Operator Window (Example)
Quality Control Configuration
Figure 114. Change Password Window (Example)
Adding/Editing Quality Controls
Adding External Quality Controls
Table 113. External Quality Control Configuration Options
Table 114. Manufacturer's Controls/Calibrators Configuration
Options
Figure 115. Add Quality Control Window (Example)
Editing Quality Controls
Copying External Quality Controls
Deleting Quality Controls
Loading Unlabeled Quality Controls
Figure 116. Copy Quality Control Window (Example)
Selecting Assays During EQC Loading
Adding Manufacturer Control/Calibrator Overrides
Figure 117. Add Manufacturer Control/Calibrator Override Window
(Example)
Reflex Testing Configuration
Table 115. Reflex Testing Configuration Options
Configuring Automatic Reflex Test Order Assignment
Configuring Reflex Test Order Assignment During Rack Load
Designating Reflex Tests During Sample Rack Loading
Assay Custom Cutoff Value Configuration
Troubleshooting
Hologic Technical Support
Troubleshooting Over the Phone
Troubleshooting with PRO360° Software
Initiating a Remote Diagnostics Session
Figure 118. Remote Diagnostics Management Window
Figure 119. PRO360° Software Window (Example)
Terminating a Remote Diagnostics Session
Panther System Operator's Manual
Instrument Information
Figure 120. PRO360° Software Connection in Progress (Example)
Instrument Info Panel
Module Information
Assay Versions
Figure 121. Instrument Info Window-Module Information View
(Example)
Silence Alarm
Force MTU Unload
Figure 122. Instrument Info Window-Assay Versions View (Example)
Send Logs
Figure 123. Send Logs Window (Example)
Send Logs Directly to Service Support
Disposing of Contaminated Waste
Figure 124. Disposing of Liquid Waste Container Contents
(Example)
Dropped Tip Inside Sample Tube
Resolving Barcode Issues
Using the Handheld Scanner for Unreadable Barcodes
Figure 125. Sample Rack Loading Screen During Barcode Error
(Example)
Using the Virtual Keyboard for Unreadable Barcodes
Unresponsive System Shutdown
Replaceable Parts
Vacuum Trap Filter Replacement
Universal Fluid Caps Replacement
Waste Bottle O-rings Replacement
Appendix A. Panther System Operation Checklist
Appendix B. Processing Flags
Assay Processing Flags
Table 116. Assay Processing Flags
Results Processing Flags
Table 117. Results Processing Flags
Appendix C. System Messages
Table 118. System Messages
Appendix D. Support Contact Information
REV AUTHORED BY DATE
CHRIS WALSH 04/09/21
REV DRAFTED BY DATE
CHRIS WALSH 04/09/21
PROPRIETARY: This document contains TITLE DOCUMENT NUMBER REV
proprietary data of Hologic, Inc. No
disclosure, reproduction or use of any part PANTHER OPERATOR'S MANUAL, V 6.2,
thereof may be made except by written GLOBAL, IVD, ENGLISH AW-17791-001 002
permission from Hologic.
REV. RELEASE DATE: 05/04/2021 SIZE A SHEET 1 OF 1

Before using this document, please consult Agile for the latest revision. Form ENG-0034-T01, Rev. 006
 This manual was produced for use with the Panther System.
Please address all questions, comments, and requests for additional copies to the
address below:

Hologic, Inc.
10210 Genetic Center Dr.
San Diego, CA 92121

U.S. and international contact information:

+1 800 442 9892
Customer Support:
[email protected]
+1 888 484 4747
Technical Support:
[email protected]

For more contact information visit www.hologic.com.

HOLOGIC, Aptima, Aptima Combo 2, Panther, TMA and associated logos, are
trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the
United States and/or other countries.
All other trademarks that may appear in this manual are the property of their respective
owners.
This product may be covered by one or more U.S. patents identified at
www.hologic.com/patents.

©2010–2020 Hologic, Inc. All rights reserved.

Panther System® Operator’s Manual

AW-17791-001 Rev. 002 (EN) i
 Revision History

Revision History
Panther System Operator's Manual
The following table lists the current revision history for the manual:

Part Number Revision Sections Revised Date

903111 1 All 2011-03
Use marking and Material
903448 A 2012-03
Nubmer
903566 A Throughout 2012-06
903629 A Throughout 2012-12
903629 A.1 Clerical correction to page ii 2013-06
AW-10867 001 Throughout 2014-02
Formatting throughout, Real Time
AW-12347 001 2014-10
TMA, Quantitative Assay
AW-12522-001 001 5.3 Software Upgrades 2015-04
AW-15263-001 001 Throughout 2016-08
AW-15263-001 002 Throughout 2017-05
AW-17791 001 6.2 Software Upgrades 2018-03
Updated European Authorized
AW-17791 002 2020-02
Representative

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 Table of Contents

Table of Contents
Revision History ii
Table of Contents iii
List of Figures xvi
List of Tables xxi
Welcome to the Panther® System 1
Description and Intended Use 1
Using this Manual 2
Intended Reader 2
What This Manual Covers 2
Typographical Conventions 2
Safety Symbols 3
Terminology 3
Special Terminology 3
Acronyms/Abbreviations 4
Compliance and Safety 6
Compliance 6
Electromagnetic Compatibility 6
Safety 6
Panther System Warnings 6
System Handling Warnings 6
System Environment Warnings 8
System Configuration Warnings 8
Sample Handling Warnings 8
Consumable, Reagent, and Fluid Warnings 9
Consumable Warnings 9
Reagent Warnings 10
Fluid Warnings 10

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 Table of Contents

Biological and Chemical Hazards 11

Electrical and Mechanical Hazards 12
Glove Usage Recommendations 13
Limitations 14
Specifications and Requirements 15
Physical Specifications 15
Environmental Requirements 15
Power Requirements 16
Internal Specifications 17
Sample Tube Specifications 18
Sample Tube Barcode Requirements 18
Sample Requirements 21
Volume Requirements 21
Dead Space Volume Requirements 22
System Capacities and Throughput 23
Operator Prerequisites 24
Overview 25
Technology Overview 25
Target Capture 25
Transcription-Mediated Amplification (TMA) 27
Hybridization Protection Assay (HPA) 27
Dual Kinetic Assay (DKA) 29
Real-Time Assays 29
Internal Controls for Aptima Assays 29
Panther System Overview 29
Introduction 29
Instrument Overview 29
Canopy 31
Panther Upper Bay Components 32
Reagent Bay 33

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 Table of Contents

Panther Tip Drawer Module 34

Sample Bay Module 34
Target Capture Reagent (TCR) Carousel 34
Panther Pipettor System 35
Fluid Pumps 35
Panther Mid Bay Components 35
Incubators 37
MTU Input Queue 38
Distributor 38
AMP Load Station 38
HPA Load Station 38
Magnetic Wash Module 38
Sample Mix Station 38
Luminometer 38
Output Queue 39
Panther Lower Bay Components 39
Computer 40
Panther Waste Drawer 41
Liquid Waste Container 41
Solid Waste Container 41
Panther Universal Fluids Drawer 41
NaOCl Bottle 41
Vacuum Pump 41
Printer 42
Panther System Software Overview 42
Introduction 42
Accessing the Panther System Software 42
Desktop Shield 42
Login Screen 43
Navigating the Software 43
Menu Bar 45

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 Table of Contents

Interactive Items 46
Selection Button 47
Status Panel 47
Status Panel Bars 48
Additional Status Panel Icons 49
Additional Status Panel Items 50
Panther System Software Screens 51
Desktop Shield Screen 51
Messages Screen 53
Comments Screen 54
Pending Screen 55
Tasks Screen 56
Universal Fluid Bay Screen 58
Waste Management Screen 59
Maintenance Activities Screen 60
Assay Reagent Bay Screen 62
Assay Reagent Loading Screen 63
Sample Rack Bay Screen 64
Sample Rack Loading Screen 66
Sample Details Screen 68
Run Status Screen 70
Test Orders Screen 72
Results Screen 73
Report Menu Screen 75
Administration Screen 76
Data Management Screen 77
System Configuration Screen 79
LIS Configuration Screen 80
Operator Management Screen 84
Change Password 84
Quality Control Configuration Screen 85

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 Table of Contents

Reflex Testing Configuration Screen 87

Assay Custom Cutoff Value Configuration Screen 89
Help Window 89
Logoff/Shutdown Screen 90
System Operation 92
System Startup 92
System Startup 92
Login/Logoff 92
Login 92
Logoff 93
System Operation 93
Load Tips 94
Load MTUs 97
Load Universal Fluids 98
Load Panther Universal Fluids 98
Replace Panther Universal Fluids 99
Empty Waste 101
Empty Waste—Warnings 101
Emptying Panther Waste 101
Perform Maintenance 104
Prime Instrument 104
Prime Criteria 105
Prime Procedure 106
Force Full Prime 106
Load Panther Assay Reagents 106
Master Lot Setup 106
Add a New Master Lot 107
Inactivate a Master Lot 108
Reactivate a Master Lot 108
Reagent Kit Date Extension 109

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 Table of Contents

Loading Panther Assay Reagents into Racks 109

Loading Panther Assay Reagents 110
Unloading Panther Assay Reagents 112
Load Samples 113
Adding a New Control/Calibrator Lot 113
Controls/Calibrators Setup 114
Control/Calibrator Processing 115
Run New Controls/Calibrators 115
Loading Samples into Sample Racks 116
Sample Defaults 117
Adding an Assay to the Sample Defaults 117
Altering Replicate Count for Sample Defaults 118
Deleting an Assay Test from the Sample Defaults 119
Configuring Additional Sample Defaults 119
Manually Download Test Orders 121
Loading Sample Racks 121
Load Sample Racks into the Sample Bay 121
Assigning a Reagent Lane for Aptima Assays 122
Editing Specimen Test Orders 123
Adding a Test Order 123
Deleting a Test Order 125
Scheduling STAT Test Orders 126
Running Controls/Calibrators as Specimens 127
Dilution Factors 127
Apply Dilution Factors 128
Delete Dilution Factors 128
Unloading Sample Racks 129
Initiating Assay Processing 130
Pausing Sample Pipetting 130
Resume Pipetting Following Pause 130

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 Table of Contents

Monitoring the System through Hardware 130

System LEDs 131
Reagent Bay Lane LEDs 131
Sample Bay Lane LEDs 132
Tip Drawer, TCR Door, and MTU Input Queue LEDs 132
System Alarm 133
Monitoring the System through Software 133
Monitoring the Menu Bar 133
Monitoring the State Indicator 134
Monitoring the Status Panel 136
Status Panel 137
Status Panel Bars 137
System Activity Updates 138
Additional Status Panel Icons 138
Monitoring Pending Tasks 140
Monitoring Reagent Status 140
Panther Assay Reagent Bay Screen 140
Assay Reagent Loading Screen 141
Run Status Screen 142
Monitoring Test Orders 142
Viewing Test Orders 143
Test Order Status 143
Monitoring Loaded Specimen Status 144
Sample Rack Bay Screen 144
Run Status Screen 145
Specimen Status 146
Specimens Panel 148
Monitoring Control/Calibrator Status 149
Assay Reagents Panel 149
Monitoring Results Timing 150

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 Table of Contents

Results Management 150

Viewing Results 150
Results Information 151
Sample Curve Report 152
Result Details 153
User Comment 154
Filter Results 154
Verifying Results 155
Editing Auto-Generated or Manually Entered Sample IDs 155
Data Export 156
Exporting to a USB Flash Drive 156
Removal of a USB Flash Drive 156
Exporting Raw Data 157
Exporting LIS Data 157
Sending Results to LIS 158
Export Viral Data 159
Reports Management 159
Selecting Reports 162
Navigating Reports 163
Printing Reports 163
Exporting Reports 164
Reports 165
Activity Log Report 165
Assay Reagent Report 166
Configuration Report 167
Diagnostics Log Report 168
Exceptions by Worklist Report 170
Exceptions Report 171
Levey-Jennings Report 173
Lot Search Report 175

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Maintenance Checklist 176

Maintenance Log Report 177
Messages Log Report 178
Prevalence Report 180
Results by Worklist Report 181
Results Report 182
Sample Audit Report 184
Test Count Report 185
Worklist Lot Report 186
System Shutdown 187
Maintenance 189
General Maintenance Information 189
Maintenance Task Summary 189
Maintenance Activities Screen 190
Maintenance Task Details Screen 191
Set Maintenance Tasks to Required 192
Schedule an Automated Maintenance Task 193
Tracking the Maintenance Schedule 194
Maintenance Reports 195
Record Maintenance Comments 195
Recommended Cleaning Agents 195
Preparing Sodium Hypochlorite Solution 198
Preparing Bleach Enhancer Solution 198
Laboratory Check and Cleaning 198
Preparing a Clean Workspace 199
Clean with Sodium Hypochlorite Solution 199
Clean with Prepared Bleach Enhancer Solution (if applicable) 199
Checking for Leaks and Spills 199
Mag Wash Clean 200
Clean the Sample Shield 201

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PC Reboot Maintenance 202

Monthly Maintenance 203
Step 1. Clean the Monitor and Scanner 203
Step 2. Clean the Tip Drawers 203
Step 3. Clean the Reagent Bay 204
Step 4. Clean the Sample Bay 204
Step 5. Clean the Panther Universal Fluid Drawer 206
Step 6. Clean the Panther Waste Drawer 207
Step 7. Clean the External Surfaces 209
Replace Mag Wash Cleaning Solution 209
Idle Maintenance 210
Clean Sample Racks and Reagent Racks 211
Database Maintenance 211
Database Backup 211
Database Restore 212
Delete Database 212
System Administration 214
Specimen Processing Modes 214
Random Access Loading—Bidirectional LIS Host Query 214
Manual Download 214
Automatic Host Query 214
Batch Loading 215
Samples with Barcodes 215
Samples without Barcodes 215
Database Administration 215
Auto Purge Log Configuration 216
Purge Logs 216
Purge Results 217
Configuration 218
User Interface 219

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Enable Automatic Log Off 220

Threshold Management 220
Waste Threshold 220
Universal Fluid Management 221
Priming Management 222
Enable Automatic Priming 222
Assay Reagent Loading 223
Default Reconstitution Date Selection 223
Specimen Loading 224
Enable Non-Barcode Sample Loading 225
Enable Auto Sample ID Assignment 225
Enable Detection and Flagging of Repeat Barcodes/Reject All Repeat Test
Orders 225
Manual Barcode Entry Mode 226
Enable Worklist ID Suffix 226
ISBT128 Barcodes Enabled 227
Results Management 227
Enable RLU Value Suppression for Aptima Combo 2 228
Panther Calibrator and/or Control Frequency 228
Report Management 229
Enable Temperature Check Reporting 229
Report Export Directory 229
Data Export Management 230
Delimiter Character for Export Files 230
Raw Data Export Directory 231
Security Management 231
Cybersecurity and Data Protection 232
Power Save Management 232
Enable Power Save Mode 234
Time to End Power Save Mode 234

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 Table of Contents

UPS Management 234

Printer Management 235
Default Printer Name 235
LIS Configuration 236
Enable LIS Connection 237
Disable the LIS Connection 238
Enable Automatic Results Holding 238
LIS Messages 239
Operator Management 240
Enable/Disable Operator Accounts 240
Adding Operator Accounts 240
Editing Operator Accounts 242
Deleting Operator Accounts 243
Change Password 243
Quality Control Configuration 244
Adding/Editing Quality Controls 245
Adding External Quality Controls 245
Editing Quality Controls 247
Copying External Quality Controls 247
Deleting Quality Controls 248
Loading Unlabeled Quality Controls 248
Selecting Assays During EQC Loading 249
Adding Manufacturer Control/Calibrator Overrides 249
Reflex Testing Configuration 251
Configuring Automatic Reflex Test Order Assignment 252
Configuring Reflex Test Order Assignment During Rack Load 252
Designating Reflex Tests During Sample Rack Loading 253
Assay Custom Cutoff Value Configuration 253
Troubleshooting 254
Hologic Technical Support 254

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 Table of Contents

Troubleshooting Over the Phone 254

Troubleshooting with PRO360° Software 254
Initiating a Remote Diagnostics Session 254
Terminating a Remote Diagnostics Session 256
Panther System Operator's Manual 256
Instrument Information 256
Instrument Info Panel 257
Module Information 257
Assay Versions 257
Silence Alarm 258
Force MTU Unload 258
Send Logs 259
Send Logs Directly to Service Support 260
Disposing of Contaminated Waste 260
Dropped Tip Inside Sample Tube 262
Resolving Barcode Issues 263
Using the Handheld Scanner for Unreadable Barcodes 263
Using the Virtual Keyboard for Unreadable Barcodes 264
Unresponsive System Shutdown 264
Replaceable Parts 265
Vacuum Trap Filter Replacement 265
Universal Fluid Caps Replacement 268
Waste Bottle O-rings Replacement 269
Appendix A. Panther System Operation Checklist 271
Appendix B. Processing Flags 272
Assay Processing Flags 272
Results Processing Flags 283
Appendix C. System Messages 290
Appendix D. Support Contact Information 398

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 List of Figures

List of Figures
Figure 1. Sample Tube Barcode Label Requirements 20
Figure 2. Target Capture 26
Figure 3. Hybridization Protection Assay 28
Figure 4. Panther System 30
Figure 5. Canopy 31
Figure 6. Panther Upper Bay 32
Figure 7. Reagent Bay 33
Figure 8. Sample Bay Module 34
Figure 9. Panther Pipettor System 35
Figure 10. Panther Mid Bay 36
Figure 11. Panther Lower Bay 39
Figure 12. Desktop Shield Screen (Example) 42
Figure 13. Login Screen (Example) 43
Figure 14. Screen Locations (Example) 44
Figure 15. Menu Bar (Example) 46
Figure 16. Row Selection Menu (Example) 47
Figure 17. Status Panel (Example) 48
Figure 18. Desktop Shield Screen (Example) 52
Figure 19. Messages Screen (Example) 53
Figure 20. Comments Screen (Example) 55
Figure 21. Pending Screen (Example) 56
Figure 22. Tasks Screen (Example) 57
Figure 23. Universal Fluid Bay Screen (Example) 59
Figure 24. Waste Management Screen (Example) 60
Figure 25. Maintenance Activities Screen (Example) 61
Figure 26. Assay Reagent Bay Screen (Example) 62
Figure 27. Assay Reagent Loading Screen (Example) 64

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 List of Figures

Figure 28. Sample Rack Bay Screen (Example) 65

Figure 29. Sample Rack Loading Screen (Example) 67
Figure 30. Sample Details Screen (Example) 69
Figure 31. Run Status Screen (Example) 70
Figure 32. Test Orders Screen (Example) 72
Figure 33. Results Screen (Example) 73
Figure 34. Report Menu Screen (Example) 75
Figure 35. Administration Screen (Example) 76
Figure 36. Data Management Screen (Example) 78
Figure 37. System Configuration Screen (Expanded Example) 79
Figure 38. LIS Configuration Screen—General Settings (Example) 81
Figure 39. LIS Configuration Screen—Serial Settings (Example) 82
Figure 40. LIS Configuration Screen—TCP/IP Settings (Example) 82
Figure 41. LIS Configuration Screen—File Settings (Example) 83
Figure 42. Operator Management Screen (Example) 84
Figure 43. Quality Control Configuration Screen—External Quality Controls Tab
(Example) 85
Figure 44. Quality Control Configuration Screen—Manufacturer's
Controls/Calibrators Tab (Example) 87
Figure 45. Reflex Testing Configuration Screen (Example) 88
Figure 46. Help Window (Example) 89
Figure 47. Logoff/Shutdown Screen (Example) 91
Figure 48. Tasks Screen (Example) 94
Figure 49. Tip Loading Management Window (Example) 95
Figure 50. Bottle Status Panel (Example) 100
Figure 51. Disposing of Liquid Waste Container Contents (Example) 103
Figure 52. Maintenance Activities Screen (Example) 104
Figure 53. New/Activate Master Log Screen (Example) 107
Figure 54. Inactivate Master Lot Window (Example) 108

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 List of Figures

Figure 55. Panther Reagent Rack (Example) 109

Figure 56. Supplemental Reagent Information Window (Example) 111
Figure 57. Supplemental Reagent Information Window—Redundant Lots
(Example) 112
Figure 58. Control/Calibrator Lot Entry Screen (Example) 114
Figure 59. Sample Rack Bay Screen (Example) 114
Figure 60. Panther Sample Rack—With Retainer 117
Figure 61. Sample Defaults Window (Example) 118
Figure 62. Expanded Sample Defaults Window (Example) 120
Figure 63. Select Reagent Lanes Window (Example) 122
Figure 64. Add Test Orders Window (Example) 124
Figure 65. Process as Specimen Checkbox (Example) 127
Figure 66. Status Panel (Example) 137
Figure 67. Temperatures and Sensors Screen (Example) 140
Figure 68. Assay Reagent Loading Screen (Example) 142
Figure 69. Assay Reagents Panel (Example) 142
Figure 70. Test Orders Screen (Example) 143
Figure 71. Run Status Screen (Example) 146
Figure 72. Sample Status Locations (Example) 147
Figure 73. Specimens Loaded Panel—Without LIS (Example) 148
Figure 74. Specimens Loaded Panel—With LIS (Example) 149
Figure 75. Assay Reagents Panel (Example) 150
Figure 76. Results Panel (Example) 150
Figure 77. Results Screen—Expanded (Example) 151
Figure 78. Sample Curve Report (Example) 152
Figure 79. Results Screen with Filters Panel (Example) 155
Figure 80. USB Storage Removal Window (Example) 156
Figure 81. Report Parameters for Results Report (Example) 162
Figure 82. Panther System Report Navigation Bar 163

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 List of Figures

Figure 83. Activity Log Report (Example) 166

Figure 84. Assay Reagent Report (Example) 167
Figure 85. Configuration Report (Example) 168
Figure 86. Diagnostics Log Report (Example) 170
Figure 87. Exceptions by Worklist Report (Example) 171
Figure 88. Exceptions Report (Example) 173
Figure 89. Levey-Jennings Report (Example) 175
Figure 90. Lot Search Report (Example) 176
Figure 91. Maintenance Checklist (Example) 177
Figure 92. Maintenance Log (Example) 178
Figure 93. Messages Log Report (Example) 180
Figure 94. Prevalence Report (Example) 181
Figure 95. Results by Worklist Report (Example) 182
Figure 96. Results Report (Example) 184
Figure 97. Sample Audit Report (Example) 185
Figure 98. Test Count Report (Example) 186
Figure 99. Worklist Lot Report (Example) 187
Figure 100. Shutdown Confirmation Window 188
Figure 101. Maintenance Activities Screen (Example) 191
Figure 102. Maintenance Task Details Screen—Clean Sample Shield (Example) 192
Figure 103. Edit Maintenance Task Screen Mag Wash Cleaning (Example) 193
Figure 104. Scheduled For Automated Start Panel (Example) 194
Figure 105. Maintenance Table (Example) 194
Figure 106. Maintenance Task Completed Screen (Example) 195
Figure 107. Disposing of Liquid Waste Container Contents (Example) 208
Figure 108. Purge Results Window (Example) 218
Figure 109. Assay Reagent Loading Window (Example) 223
Figure 110. Delimiter Character for Export Files Window 231
Figure 111. LIS Messages Window with ASTM 1394 Selected (Example) 239

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 List of Figures

Figure 112. Add Operator Window (Example) 241

Figure 113. Edit Operator Window (Example) 243
Figure 114. Change Password Window (Example) 244
Figure 115. Add Quality Control Window (Example) 246
Figure 116. Copy Quality Control Window (Example) 248
Figure 117. Add Manufacturer Control/Calibrator Override Window (Example) 250
Figure 118. Remote Diagnostics Management Window 255
Figure 119. PRO360° Software Window (Example) 255
Figure 120. PRO360° Software Connection in Progress (Example) 256
Figure 121. Instrument Info Window—Module Information View (Example) 257
Figure 122. Instrument Info Window—Assay Versions View (Example) 258
Figure 123. Send Logs Window (Example) 259
Figure 124. Disposing of Liquid Waste Container Contents (Example) 261
Figure 125. Sample Rack Loading Screen During Barcode Error (Example) 263

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 List of Tables

List of Tables
Table 1. Changing Gloves 14
Table 2. Size and Weight Specifications 15
Table 3. Clearance Specifications 15
Table 4. Environmental Requirements 16
Table 5. Environmental Output 16
Table 6. Power Requirements 17
Table 7. Internal Specifications 17
Table 8. Sample Tube Requirements 18
Table 9. Barcode Requirements 19
Table 10. Allowable Barcode Characters 21
Table 11. Panther System Volume Requirements 22
Table 12. Panther System Dead Space Volume Requirements 23
Table 13. System Capacities and Throughput 24
Table 14. Panther System Components 31
Table 15. Canopy Location Descriptions 31
Table 16. Panther Upper Bay Descriptions 33
Table 17. Panther Mid Bay Descriptions 37
Table 18. Panther Lower Bay Descriptions 40
Table 19. Login Screen Interactive Item Descriptions 43
Table 20. Universal Screen Interactive Item Descriptions 45
Table 21. Menu Button Descriptions 46
Table 22. Interactive Item Descriptions 46
Table 23. Row Selection Menu Buttons 47
Table 24. Status Bar Updates 48
Table 25. Additional Status Icon Descriptions 50
Table 26. Additional Status Panel Items 50
Table 27. Desktop Shield Screen Button Descriptions 52

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 List of Tables

Table 28. Message Screen Descriptions 54

Table 29. Comments Screen Descriptions 55
Table 30. Tasks Screen Buttons 58
Table 31. Universal Fluid Bay Screen Descriptions 59
Table 32. Waste Management Screen Descriptions 60
Table 33. Maintenance Activities Screen Descriptions 62
Table 34. Assay Reagent Bay Screen Descriptions 63
Table 35. Assay Reagent Loading Screen Descriptions 64
Table 36. Sample Rack Bay Screen Descriptions 66
Table 37. Sample Rack Loading Screen Descriptions 68
Table 38. Sample Details Screen Descriptions 70
Table 39. Run Status Screen Descriptions 72
Table 40. Test Orders Screen Descriptions 73
Table 41. Results Screen Descriptions 74
Table 42. Report Menu Screen Descriptions 76
Table 43. Administration Screen Button Descriptions 77
Table 44. Data Management Screen Button Descriptions 79
Table 45. System Configuration Screen Descriptions 80
Table 46. LIS Configuration Screen Location Descriptions 83
Table 47. Operator Management Screen Location Descriptions 84
Table 48. Quality Control Configuration Screen Button Descriptions (External
Quality Controls Tab) 86
Table 49. Quality Control Configuration Screen Button Descriptions (Manufacturer's
Controls/Calibrators Tab) 87
Table 50. Reflex Testing Configuration Screen Button Descriptions 88
Table 51. Help Window Buttons 90
Table 52. Logoff/Shutdown Screen Buttons 91
Table 53. Tip Replacement Options 96
Table 54. System Prime Resource Consumption 105

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 List of Tables

Table 55. Additional Sample Default Options 120

Table 56. System LED Status Color Legend 131
Table 57. Reagent Bay Lane LED Status Color Legend 132
Table 58. Sample Bay Lane LED Status Color Legend 132
Table 59. Tip Drawer, TCR Door, and MTU Input Queue LED Status Color Legend 132
Table 60. Menu Bar Status Descriptions 134
Table 61. System State Indicators 136
Table 62. Status Bar Updates 138
Table 63. Status Icon Descriptions 140
Table 64. Reagent Rack Status Color Legend 141
Table 65. Assay Reagent Status Color Legend 141
Table 66. Test Order Screen Fields 143
Table 67. Test Order Status Definitions 144
Table 68. Sample Rack Status Color Legend 145
Table 69. Specimen Status Definitions 148
Table 70. Control/Calibrator Status Definitions 149
Table 71. Reports 161
Table 72. Report Navigation Buttons 163
Table 73. Activity Log Report—Report Parameters 166
Table 74. Assay Reagent Report—Report Parameters 167
Table 75. Diagnostics Log Report—Report Parameters 169
Table 76. Exceptions by Worklist Report—Report Parameters 171
Table 77. Exceptions Report—Report Parameters 172
Table 78. Levey-Jennings Report—Report Parameters 174
Table 79. Lot Search Report—Report Parameters 176
Table 80. Maintenance Checklist —Report Parameters 177
Table 81. Maintenance Log Report—Report Parameters 178
Table 82. Messages Log Report—Report Parameters 179
Table 83. Prevalence Report—Report Parameters 180

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 List of Tables

Table 84. Results by Worklist Report—Report Parameters 182

Table 85. Results Report—Report Parameters 183
Table 86. Sample Audit Report—Report Parameters 184
Table 87. Test Count Report—Report Parameters 185
Table 88. Worklist Lot Report—Report Parameters 186
Table 89. Maintenance Task Summary 190
Table 90. Recommended Cleaning Agents 197
Table 91. Environmental Specifications 198
Table 92. Example Mag Wash Maintenance Tasks Cleaning Schedules 200
Table 93. Mag Wash Cleaning Inventory 201
Table 94. Idle Maintenance Procedures 210
Table 95. User Interface Options 220
Table 96. Threshold Management Options 220
Table 97. Universal Fluid Management Options 221
Table 98. Priming Management Options 222
Table 99. Assay Reagent Loading Options 223
Table 100. Specimen Loading Options 225
Table 101. Manual Barcode Entry Modes 226
Table 102. ISBT128 Barcodes Stripping Options 227
Table 103. Results Management Options 228
Table 104. Report Management Options 229
Table 105. Data Export Management Options 230
Table 106. Security Management Options 232
Table 107. Power Save Management Options 233
Table 108. UPS Management Setting Options 235
Table 109. Printer Settings Options 235
Table 110. LIS Configuration Options 237
Table 111. Operator Management Options 240
Table 112. Operator Roles 242

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 List of Tables

Table 113. External Quality Control Configuration Options 245

Table 114. Manufacturer's Controls/Calibrators Configuration Options 245
Table 115. Reflex Testing Configuration Options 251
Table 116. Assay Processing Flags 282
Table 117. Results Processing Flags 289
Table 118. System Messages 397

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 Welcome to the Panther® System

Welcome to the Panther® System

For In Vitro Diagnostic Use

© 2010–2020. All rights reserved.

This manual contains instructions for preparing the Panther System for operation, running
tests, viewing results, regular cleaning, maintenance, and troubleshooting. All sections of
this manual can be printed for review offline.

Description and Intended Use

The Panther System is an integrated nucleic acid testing system which fully automates all
steps necessary to perform Aptima® assays from sample processing through
amplification, detection, and data reduction.

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 Using this Manual

Using this Manual

Intended Reader
This manual is for laboratory professionals who operate the Panther System.

What This Manual Covers

l Compliance and Safety—Lists the warnings and cautions related to operator
safety and assay results.
l Specifications and Requirements—Contains reference information about
resource requirements and system capacities.
l Overview—Provides an overview of the Panther System hardware and software.
l System Operation—Instructions for preparing the instrument, performing an
assay run, and interpreting assay results.
l Maintenance—Lists maintenance and cleaning procedures.
l System Administration—Describes procedures for configuring the Panther
System.
l Troubleshooting—Instructions for working with Hologic Technical Support to
troubleshoot issues.
l Appendix A. Panther System Operation Checklist—Provides an overview of
workflow tasks.
l Appendix B. Processing Flags—Describes the meanings and outcomes of
Assay Processing and Results Processing Flags.
l Appendix C. System Messages—Describes the meanings of system
messages, possible causes, and solutions.
l Appendix D. Support Contact Information—How to contact Hologic Technical
Support and Customer Support.

Typographical Conventions
l Uppercase is used for acronyms and copyrighted/trademarked terms where
upper-case is the expected form.
l Italics are used for cross-references, document titles, minor emphasis, and
software window titles.
l Bold is used for headings, lists of terms, and software interface objects.
l Bold Italics are used for table and figure captions, warnings, and notices.
l Underline is used for special emphasis in procedures.
l Bullets are used to delineate list items.

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 Using this Manual

Safety Symbols
Sections marked with safety symbols contain information for optimal operation of the
Panther System. Attention to these advisories prevents harm to operators, damage to
the system, and compromised test results.

Note—Important details of the processes performed by Panther System

operators.

Caution—Caution indicates the possibility of 1) instrument damage or data

loss if instructions are not followed, or 2) compromising of sample(s) integrity
due to cross-contamination or improper volume verification.

Warning—A hazard or operational warning. Not following the specified

directions or guidelines could result in harm to the operator, damage to
the equipment, or compromised test results. Indicates the possibility of
severe personal injury or loss of life if the instructions are not followed.

Electrical Warning—An instruction that, if not followed, can result in

electric shock.

Hot Surface Warning—An instruction that, if not followed, can result in

exposure to surfaces that could potentially burn the operator.

Biohazard Warning—An instruction that, if not followed, can result in

exposure to biohazardous material.

Corrosive Warning—An instruction that, if not followed, can result in

exposure to a corrosive liquid or substance.

Pinch-Point Warning—An instruction that, if not followed, can result in

exposure to mechanical pinch-point hazard.

Laser Warning—An instruction that, if not followed, can result in eye

damage.

Additional symbols may be used with assay reagents and fluids. These symbols will
be explained in individual packaging.

Terminology
Special Terminology
The following special terminology is used in this manual:

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 Using this Manual

l Specimens—Clinical material collected from a patient, where the collection

method is either a swab, urine, blood, or other alternative specimen type, placed
in an appropriate specimen transport system for testing on the Panther System.
l Samples—Represents a more generic term to describe any material for testing
on the Panther System (e.g., specimens, controls, and calibrators).

Acronyms/Abbreviations

Abbreviation/
Acronym Definition

AE Acridinium Ester

Amp Amplification

ANSI American National Standards Institute

COP Communication and Organization Processor

DI Deionized

DKA Dual Kinetic Assay

DNA Deoxyribonucleic Acid

EMC Electromagnetic Compatibility

EQC External Quality Control

HPA Hybridization Protection Assay

IEC International Electrotechnical Commission

IUO Investigational Use Only

IVD In Vitro Diagnostics

LIS Laboratory Information System

LLD Liquid Level Detection

Mag Wash Magnetic Wash Station

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 Using this Manual

Abbreviation/
Acronym Definition

MTU Multi-Tube Unit

NaOCl Sodium Hypochlorite; Bleach

PEO Performance Evaluation Only

PMT Photo-Multiplier Tube

PPE Personal Protective Equipment

RFID Radio Frequency Identification

RLU Relative Light Units

RNA Ribonucleic Acid

RUO Research Use Only

SID Sample Identification

TCR Target Capture Reagent

TER Target Enhancer Reagent

TMA Transcription Mediated Amplification

UI User Interface

UPS Uninterruptible Power Supply

VTM Viral Transport Medium

wTCR Working Target Capture Reagent

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 Compliance and Safety

Compliance and Safety

Additional training and assay evaluation will be required for any additional assays that
are subsequently cleared on the Panther System.
Read this manual before using the Panther System. Upon completion of training, keep
this manual available for reference.

Compliance
Electromagnetic Compatibility
The Panther System has been tested according to the following directives.
l IEC 61326-2-6:2012 Electrical equipment for measurement, control, and
laboratory use—EMC requirements Part 2-6: Particular requirement—In vitro
Diagnostic (IVD) medical equipment.

Safety
Follow standard laboratory precautions when operating the Panther System. The
warnings in this section apply specifically to the Panther System and its related
components.
Hologic does not take any responsibility for unauthorized modifications of the
instrument or for failure of operating personnel to heed the warnings and cautions.
Any equipment used in a manner not specified by Hologic, Inc., may become unsafe.
Review all the warnings in this section before operating the Panther System.

Panther System Warnings

Warning—The following warnings apply to general use of the
Panther System. Additional warnings are listed throughout the
manual.

System Handling Warnings

l The Panther System must be installed and qualified by Hologic authorized
personnel.
l Do not modify the Panther System hardware or software without written
authorization from Hologic. Do not add accessories, or use supplies not
authorized by Hologic.
l Except for the maintenance instructions specifically articulated in this
manual, do not attempt to service the Panther System. Repairs should be
performed by qualified authorized personnel only.

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 Compliance and Safety

l Do not attempt to move the Panther System without the assistance of

Hologic authorized personnel.
l The Waste Drawers, Tip Drawers, TCR Door, Fluids Drawer, and MTU Input
Queue are locked during operation. Unlock doors and drawers before
opening. Do not force open doors or drawers.
l In the event of an observable fluid leak, decontaminate using approved
methods. Contact Hologic Technical Support for additional information or
assistance.
l If a spill, leak, or overflow occurs in an inaccessible area inside the
instrument, contact Hologic Technical Support. Do not try to clean
inaccessible parts of the instrument without proper assistance.
l If a small sample, reagent, or universal fluid spill occurs inside an easily
accessed area of the Panther System, wipe the area with a wipe that
contains 2.5%–3.5% sodium hypochlorite solution. Allow the 2.5%–3.5%
sodium hypochlorite solution to remain in contact with the surface for at least
one minute. Do not allow the sodium hypochlorite solution to dry. Wipe the
area with DI water. If a large spill occurs, contact Hologic Technical Support
for assistance.
l Follow all written and onscreen instructions for safe and effective use of the
Panther System.
l Only properly trained personnel should operate and perform maintenance on
the Panther System.
l The covers of the Panther System should be removed by Hologic authorized
personnel only. Operators should not remove the covers.
l The service access drawer should only be opened by Hologic authorized
personnel.
l Follow all instructions in the Panther System Operator's Manual, software
screens, and in the appropriate assay package insert.
l Inspect all materials—including fluids, reagents, and supplies—for damage,
deterioration, and expiration date. Do not use the system or ancillary parts if
damaged.
l For routine surface decontamination, refer to the Monthly Maintenance
section (see Monthly Maintenance on page 203). Do not spray sodium
hypochlorite solutions, prepared Bleach Enhancer solution, or water directly
onto the Panther System surfaces. Treat surfaces using wipes moistened
with appropriate cleaning solutions.
l Only connect approved components to the Panther System and computer
workstation.
l Do not shut down the instrument or computer while the system is starting up
or running.
l Shut down the computer using the system software. Do not use the computer
power button to shut off the computer.

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 Compliance and Safety

l A physical keyboard is required for use with PRO360. Do not use the
keyboard for other purposes unless instructed by Hologic personnel or the
instructions outlined in the Panther System Operator's Manual (see
Troubleshooting with PRO360° Software on page 254).
l Do not remove Reagent or Sample Racks that are currently in use by the
system. Do not remove racks when the lane LED is red and the rack graphic
on the screen is yellow with a red border.

System Environment Warnings

l Do not expose the Panther System to direct sunlight or extreme
temperatures.
l The work area must have adequate sink facilities to accommodate the
procedures described in this manual. Sink facilities for waste disposal
should be separate from sink facilities for preparing cleaning solutions.
Waste and reagent disposal facilities should meet established laboratory
policies.
l Prior to preparing an assay run, clean all work surfaces and equipment with
the appropriate sodium hypochlorite solution or prepared Bleach Enhancer
solution. Refer to the instructions in the appropriate package insert and the
appropriate section in the Panther System Operator's Manual (see Preparing
a Clean Workspace on page 199).
l This equipment has been designed and tested to CISPR 11 Class A. In a
domestic environment it may cause radio interference. Take measures to
mitigate the risk as needed.
l Do not use this device in close proximity to sources of strong
electromagnetic radiation as these may interfere with the proper operation.

System Configuration Warnings

l Do not include Start/Stop characters (if present) when manually entering a
Sample ID. A mismatch will occur between the actual Sample ID and the ID
in the printed report.
l Use only the Sample Racks and specimen tubes that are designed for use
on the Panther System. Refer to the appropriate package insert for more
information.
l Always back up the current database before restoring it. Do not restore the
database unless directed by authorized Hologic personnel.

Sample Handling Warnings

l Do not run sample types on the Panther System other than those approved
for the assay currently being run. Refer to the appropriate assay package
insert and/or collection device package insert for regulatory clearances
required for use on the Panther System.

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 Compliance and Safety

l Avoid touching the tops of calibrators, controls, and specimens during

preparation and loading.
l Ensure that all tubes are loaded straight and seated firmly in the Sample
Rack. The Sample Retainer will not fit on the Sample Rack unless all tubes
are properly loaded.
l Handle calibrators, controls, and specimens cautiously to prevent
splashing/spilling. Always keep the Sample Racks upright.
l Mishandling samples can compromise assay results.
l To avoid pipetting errors, do not process a sample with less than the
minimum recommended volume (see Volume Requirements on page 21 for
minimum sample volume requirements).
l Using sample barcodes with check digits is recommended in order to reduce
the risk of barcode misreads.

Consumable, Reagent, and Fluid Warnings

Warning—The following warnings apply to the general use of the
Panther System. Additional warnings are listed throughout the
manual.

Consumable Warnings
l Inspect all consumables for damage or leaking before use. Do not use if
damaged or leaking.
l Do not reuse disposable pipette tips. Use only pipette tips that are
recommended by Hologic. Use of unapproved tips can interfere with
assay or system performance.
l Do not reuse MTUs, Waste Bags, or Waste Covers. Use only MTUs,
Waste Bags, and Waste Covers supplied by Hologic. Use of
unapproved MTUs, Waste Bags, and Waste Covers can interfere with
assay or system performance.
l Dispose of dropped tips or MTUs.
l Use the cardboard box to load MTUs. Do not touch individual MTUs or
load them individually by hand. Only touch when discarding faulty or
damaged MTUs.
l Avoid touching the tops or bottoms of pipette tips.
l Load only full pipette tip trays. Do not insert individual pipette tips into
the trays. The Panther System tracks tip positions it has used.
l Failure to replace all empty racks with tips after loading may result in an
inaccurate tip count or tip pick failures which may cause invalid
worklists or samples.

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 Compliance and Safety

Reagent Warnings
l Do not load any reagents into the Panther System that have not been
approved for use in the Panther System.
l Do not top off reagent bottles. The Panther System will recognize and
reject bottles that have been topped off. Discard unused reagents
according to laboratory policies.
l Inspect all packaged reagents for damage and expiration before use.
Do not use if damaged or expired.
l Always prepare a clean work surface before preparing reagents.
l Avoid contaminating the reagents with specimens.
l Do not spill reagents. Accidental reagent spills may result in instrument
errors and/or decrease in reagent test count.
l Inspect reagents for undissolved particles, bubbles, or foam before
loading them onto the Panther System.
l Avoid creating foam when resuspending and mixing reagents. Do not
use reagents with foam in the Panther System. If more than a trace
amount of foam is visible, do not use the reagent. Foam impairs the
level-sensing mechanism of the pipettors.
l Handle all reagents according to the instructions in the applicable
package insert and as outlined in this manual. Exercise caution when
opening reagents.
l Probe and Promoter Reagents and reconstituted Probe and Promoter
Reagents are photosensitive. Do not store Probe or Promoter Reagent
where they could be exposed to direct light.
l If refrigerated, allow the previously reconstituted solutions to reach room
temperature before use.
l Always use a new cap when recapping a reagent bottle.
l Reagents should be prepared in a dedicated template free work space,
away from the sample preparation area. Keep specimens, controls, and
calibrators away from the reagent preparation area.
l Failure to properly prepare reagents may adversely affect test results.
l Avoid touching the tops of open reagents during preparation and
loading.
l To ensure accurate test results, follow all instructions in the appropriate
assay package insert.

Fluid Warnings
l Do not load any fluids into the Panther System that have not been
approved for use in the Panther System.
l Inspect all fluids for damage before use. Do not use if damaged.

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 Compliance and Safety

l Always handle fluids before handling waste to prevent waste from

contaminating any Universal Fluids.
l Avoid touching the tops of open fluids during preparation and loading.
l Panther Universal Fluids contain RFID tags located under the label
beneath the white arrow. Align the RFID tag with the RFID antenna
found in the Panther Universal Fluids drawer to avoid errors when
replacing Universal Fluid bottles.
l Whenever replacing Panther Universal Fluids bottles, inspect caps for
any clogged vent holes. Clear any clogged vent holes by wiping with
paper towels and DI water.

Biological and Chemical Hazards

Warning—The following warnings apply to biological and chemical
hazards related to the use of the Panther System. Additional
warnings are listed throughout the manual.

Corrosive Warning—Auto Detect 2 contains 1.6 N sodium

hydroxide. This fluid is corrosive and can cause burns. In case of
eye contact, flush the eye immediately with water and seek medical
attention.

Corrosive Warning—The NaOCl Bottle and the Liquid Waste Bottle

contain sodium hypochlorite. Avoid contact with skin, eyes, and
mucous membranes. Wash affected area with water if contact with
this fluid occurs. If the fluid spills, dilute with water before wiping
dry. Follow laboratory procedures for working with sodium
hypochlorite. Do not autoclave the NaOCl Bottle or the Liquid
Waste Bottle.

Corrosive Warning—Target Enhancer Reagent contains lithium

hydroxide. Lithium hydroxide is corrosive and causes burns. In
case of contact with eyes, rinse immediately with plenty of water
and seek medical advice.

Warning—Do not use material that may contain Guanidinium

thiocyanate or any guanidine-containing materials on the
instrument. Highly reactive and/or toxic compounds may form if
combined with sodium hypochlorite.

l Follow Universal Precautions when handling all samples and when

performing all maintenance activities. Wear safety equipment or apparel,
including gloves, safety glasses, and lab coats, at all times when working
with liquids in and around the equipment.

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 Compliance and Safety

l Treat all specimens as potentially infectious material.

l Clean spilled waste immediately by wiping the surface with a 2.5%–3.5%
sodium hypochlorite solution. Let the sodium hypochlorite solution sit for one
minute and then wipe with DI water.
l Apply Universal Precautions when handling and disposing of both liquid and
solid waste. The Liquid Waste Bottle, a potential source of contamination,
may contain infectious biohazardous waste and sodium hypochlorite
solution. Handle and dispose of all solid and liquid waste according to
laboratory policies.
l System cleaning procedures do not guarantee that waste is not infectious.
l Do not apply excessive force to the waste bag while handling. If the waste
bag is punctured, remove any protruding tips while following Universal
Precautions, and place the entire bag and contents into a new bag.
l If a tip is present following a power loss, biohazardous material may remain
in the tip. Following Universal Precautions, use a paper towel treated with
sodium hypochlorite to carefully remove the tip. Appropriately dispose of the
tip according to laboratory policies.
l Leaks, splashes, and drips from the sample pipettor may contain
biohazardous materials.
l Thoroughly clean and disinfect all work surfaces (see Preparing a Clean
Workspace on page 199). Follow laboratory guidelines to clean up any
sodium hypochlorite solution spills that occur during system maintenance.
l If a biohazardous spill occurs outside the Panther System, follow the
procedure for disinfection (see Preparing a Clean Workspace on page 199).

Electrical and Mechanical Hazards

Warning—The following warnings apply to electrical and
mechanical hazards related to the use of the Panther System.
Additional warnings are listed throughout the manual.

l Never touch any switches or outlets with wet hands.

l Perform only maintenance or service procedures that are prescribed in this
manual. All other service and maintenance should be performed by Hologic
authorized personnel only.
l Do not operate the Panther System if liquid could have leaked, spilled, or
overflowed onto electrical components.
l The mains inlet connector located on the rear left of the instrument is used as
disconnecting device. Do not block or impede access to the mains inlet
connector with reagents, samples, consumables, or equipment. Ensure that
the mains inlet connector remains easily accessible during system
operation.
l Completely power down the Panther System before disconnecting the AC
power cord. Only Hologic authorized personnel should perform electrical
servicing.

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 Compliance and Safety

l Do not place reagents, samples, or consumables in locations within the

system other than as directed in this manual. Ensure that motorized
equipment parts are not blocked by any specimen tubes, racks, reagent
bottles, or other equipment.
l Do not manually move the pipettor arms unless instructed by Hologic
authorized personnel.
l When the TCR door or canopy doors are opened as part of a task or
maintenance procedure, do not access or touch areas not specifically
addressed in this manual.
l Do not attempt to add or remove reagents from the carousel if it is in motion.
l Do not open the TCR door or canopy doors when the pipettors or the TCR
Carousel are in motion. Do not open the canopy doors when in the Assay
Processing state.
Pinch Warning—Do not attempt to gain access to the Panther
System (except through the Sample and Reagent Bay doors or
the MTU, and Tip Drawers) while the Panther System is in the
Assay Processing state.

Hot Surface Warning—Avoid touching surfaces marked with a

hot surface symbol.

Laser Warning—This product utilizes internal barcode scanners

with visible red laser light. Long term viewing of the laser light
could result in eye damage. Never stare into the barcode
scanner laser light. This is a Class 2 laser product in
accordance to EN 60825-1: 2007 and complies with 21 CFR
1040.10 and 1040.11 except for deviations pursuant to Laser
Notice No. 50, dated June 2007.

Glove Usage Recommendations

Warning—Never reuse gloves.

Gloves provide a necessary protective barrier when handling potentially infectious

substances. Wearing gloves does not replace the need for hand washing; always wash
hands after gloves are removed.
Powderless gloves are recommended when interacting with the Panther System. Gloves
must be changed after contact with cleaning solutions, samples, and Panther System
waste locations. Changing gloves after contact with samples or potentially contaminated
instrument locations helps to prevent transmission of contaminants to other parts of the
Panther System or other locations within the laboratory.

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 Compliance and Safety

Table 1. Changing Gloves

Change Gloves Condition

Change gloves l Preparing or loading reagents or fluids.

before … l Handling specimens, calibrators, and controls.
l Loading pipette tips or MTUs.
l Unloading reagents or fluids.
l Unloading Sample Racks.
l Performing maintenance procedures on the system.
l Touching lab equipment, including refrigerators and freezers.

Change gloves l Cleaning work surfaces or handling sodium hypochlorite

after … solution.
l Cleaning Sample and Reagent Racks.
l Handling specimens, calibrators, and controls.
l Any liquids appear on a glove.
l Performing maintenance procedures on the system.
l Handling Panther solid or liquid waste.
l When holes or tears are noted or when the glove's ability to
function as a barrier is compromised.

Limitations
l Reagent and sample barcodes are not tracked between multiple Panther Systems.
l It is the responsibility of the System Administrator to ensure that the LIS data transfer
is properly validated with the LIS system at each site.
l The last line of the LIS export file contains a Cyclic Redundancy Checksum (CRC) tag
that can be used in a computer program to verify the file contents. Hologic Technical
Support can provide instructions to LIS programmers on verification of the CRC tag.
l Results verification subsequent to LIS transmission is the responsibility of each user
to properly validate.
l It is the responsibility of the user to ensure that the system is operated according to the
environmental requirements documented in the System Specifications and
Requirements section (see Specifications and Requirements on page 15).
l Performance of the Panther System has not been determined for altitudes above
2,000 m (6,562 feet).

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 Specifications and Requirements

Specifications and Requirements

This section contains reference information about the specifications of the Panther
System, the requirements for running the system, and system output and capacities.

Physical Specifications
Table 2. Size and Weight Specifications
Component Dimensions (W x D x H) Weight

Panther 122.0 x 81.5 x 175.0 cm 363 kg

(48 x 32 x 69 in) (800 lbs)

UPS (Optional) 21.4 x 41.0 x 32.5 cm 34.5 kg

(8.4 x 16.1 x 12.8 in) (76 lbs)

Table 3. Clearance Specifications

Component Dimension Clearance

Panther Width 183 cm (6 ft) Minimum

244 cm (8 ft) Recommended

Front 91.4 cm (3 ft)

Vertical 198 cm (6.5 ft)

Environmental Requirements
Table 4. Environmental Requirements
Environment Indoor use only

Sunlight No direct sunlight

Sunlight may mislead optical sensors and affect

performance

Dust No excessive dust

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 Specifications and Requirements

Table 4. Environmental Requirements (Continued)

Altitude Operation: Altitude equal to or less than 2,000 m
(6,562 ft) above sea level
Storage: As required for travel

Ambient Temperature Operating: 15–30 °C

Storage: 5–45 °C
Transport: -20–70 °C

Relative Humidity Operating: 20–85% non-condensing

Storage: 10–90% non-condensing
Transport: 10–90% non-condensing

Pollution Degree 2

Installation Class II

Table 5. Environmental Output

Heat Dissipation 550 watts (1878 BTU/hour) during steady state

Drain Output None: waste fluids drain to removable containers

Noise Output < 60 db (A)

Power Requirements
Table 6. Power Requirements
Voltage 100–240 ± 10% VAC

Frequency 50–60 Hz, 1800 VA single phase

Current Input Minimum of 15 amp circuit (dedicated)

20 amp circuit (dedicated if used with optional UPS)

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 Specifications and Requirements

Table 6. Power Requirements (Continued)

Current Draw Average: 700 W
Peak: 1400 W
l 100 VAC circuit draws 13 amps
l 240 VAC circuit draws 5.4 amps

Fuse Thermal circuit breaker

Internal Specifications
Table 7. Internal Specifications
Module Specifications

Incubators

Incubator 1: High Temperature

63.5–64.5 °C
(HT)

Incubator 2: Transition (TRAN) 43.2–44.7 °C

Incubator 3: Amplification (AMP) 42.4–43.0 °C

Load Stations

HPA 70.5–73.5 °C

AMP 44–46 °C

Bays

Reagent 16.5–19.5 °C

Sample 15.5–22.5 °C

Pumps

Vacuum Pump 4.0–12.0 inHg, target 7.0 inHg

Ramps

Chiller 17–19 °C

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 Specifications and Requirements

Note—If starting at ambient temperature or if exiting from the Power Save

state, it may take up to 33 minutes for incubator temperatures to reach
operating temperature.

Sample Tube Specifications

Refer to the appropriate assay package insert for additional sample tube
specifications. All sample tubes must have labeling that meets the height and width
requirements in the Barcode Requirements table.
Table 8. Sample Tube Requirements
Type Size Material

Specimen 12 x 75 mm to 16 x 100 mm Polypropylene plastic

(including 13 x 75 mm, 13 x 100 mm, or siliconized glass
16 x 75 mm, and 13 x 82 mm)

Calibrators 13 mm x 82 mm Polypropylene plastic

Sample Tube Barcode Requirements

All barcodes must meet the following requirements.

Table 9. Barcode Requirements

Size (Maximum Height) 61 mm (2.4 in)

Label Skew < 7.5° from vertical

16 mm (0.6 in) or 10 times the feature size,

Minimum Height
whichever is greater

Minimum Width 13 mm (0.5 in)

Quiet Zone 1.6 mm (≥ 0.06 in)

Top of label must be ≤ 86 mm (≤ 3.39 in) from

bottom of tube
Placement
Bottom of label must be ≥ 20 mm (≥ 0.78 in)
from bottom of tube

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 Specifications and Requirements

Table 9. Barcode Requirements (Continued)

Code 39 (checksum optional), Code 128
(ISBT 128), Codabar (checksum optional),
Format Interleaved 2 of 5 (checksum optional), JAN13
(checksum optional), Code 93 (checksum
optional), NW7, UPC (checksum optional)

Number of Characters 4–20

7-bit ASCII characters hexadecimal reference

numbers 33–126, excluding those noted in
the table below. No spaces or commas. The
Allowed Characters full list of allowable characters is shown in
Table 10.
Note—Spaces before, after, or within the
barcode are not accepted by the system.

Feature Size 6.5–12 mil (0.160–0.305 mm)

Print Resolution Minimum 300 dpi, recommended 600 dpi

Print Contrast Signal ≥ 0.6

Quality ANSI X3.182 grade C or higher

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 Specifications and Requirements

Figure 1. Sample Tube Barcode Label Requirements

Table 10. Allowable Barcode Characters

HEX CHR HEX CHR HEX CHR HEX CHR
000 Not Allowed 032 Not Allowed 064 @ 096 `
001 Not Allowed 033 ! 065 A 097 a
002 Not Allowed 034 " 066 B 098 b
003 Not Allowed 035 # 067 C 099 c
004 Not Allowed 036 $ 068 D 100 d
005 Not Allowed 037 % 069 E 101 e
006 Not Allowed 038 & 070 F 102 f
007 Not Allowed 039 ' 071 G 103 g
008 Not Allowed 040 ( 072 H 104 h
009 Not Allowed 041 ) 073 I 105 i
010 Not Allowed 042 * 074 J 106 j
011 Not Allowed 043 + 075 K 107 k
012 Not Allowed 044 Not Allowed 076 L 108 l
013 Not Allowed 045 - 077 M 109 m
014 Not Allowed 046 . 078 N 110 n
015 Not Allowed 047 / 079 O 111 o
016 Not Allowed 048 0 080 P 112 p
017 Not Allowed 049 1 081 Q 113 q

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 Specifications and Requirements

Table 10. Allowable Barcode Characters (Continued)

HEX CHR HEX CHR HEX CHR HEX CHR
018 Not Allowed 050 2 082 R 114 r
019 Not Allowed 051 3 083 S 115 s
020 Not Allowed 052 4 084 T 116 t
021 Not Allowed 053 5 085 U 117 u
022 Not Allowed 054 6 086 V 118 v
023 Not Allowed 055 7 087 W 119 w
024 Not Allowed 056 8 088 X 120 x
025 Not Allowed 057 9 089 Y 121 y
026 Not Allowed 058 : 090 Z 122 z
027 Not Allowed 059 ; 091 [ 123 {
028 Not Allowed 060 Not Allowed 092 \ 124 |
029 Not Allowed 061 = 093 ] 125 }
030 Not Allowed 062 Not Allowed 094 ^ 126 Not Allowed
031 Not Allowed 063 ? 095 _ 127 Not Allowed

Sample Requirements
All specimen tubes must contain sufficient liquid for processing, and must be free of
bubbles and precipitates. See the appropriate package insert for additional sample
handling instructions.

Volume Requirements
The following table describes the minimum volume requirements and replicates
available for testing when prepared properly according to the package insert.
Table 11. Panther System Volume Requirements
Minimum Pipetting Replicates for
Tube/Specimen Type Volume Testing

Aptima Specimen Transfer Tube 400 μL Up to 6*

Aptima Urine Specimen Transport

400 μL or 500 µL** Up to 3
Tube – Urine specimens

Swab Specimen Transport Tube –

400 μL Up to 3
Unisex swab specimens

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 Specifications and Requirements

Table 11. Panther System Volume Requirements (Continued)

Minimum Pipetting Replicates for
Tube/Specimen Type Volume Testing

Swab Specimen Transport Tube –

400 μL Up to 3
Vaginal swab specimens

Cervical Specimen Collection and

400 μL Up to 3
Transport specimens

Multitest Swab Transport Tube 400 μL Up to 3

Primary Collection Tube – Plasma

500 μL Not applicable
or serum

Specimen Aliquot Tube (SAT) –

500 μL Not applicable
Plasma or serum

*An invalid rate of up to 5% may be seen with pipetting of the 6th replicate on the
Panther System.
**Pipetting volumes differ based on assay. Refer to the appropriate package insert
for minimum pipetting volumes.

Each control or calibrator tube can only be tested once. Attempts to pipette from the
sample tube beyond what is described here can lead to processing errors.
Processing a specimen with less than the minimum volume may result in errors. The
total specimen volume required in each specimen tube includes both the aspirated
volume and the dead volume.

Dead Space Volume Requirements

Dead space volume requirements must be taken into account. Dead space volume is
defined as the volume of sample in a tube that must be present in order for the
system to initiate pipetting.
Depending on the Aptima assay, sample tubes must have at least the required
sample pipetting volume of 400 μL, plus the dead space volume of 1300 μL; or
sample pipetting volume of 500 μL, plus the dead space volume of 700 μL. See the
appropriate Aptima package insert for more information.
Each primary collection tube sample must have at least the required sample pipetting
volume of 500 μL, plus the dead space volume of 700 μL. Each specimen aliquot
tube (SAT) sample must have at least the required sample pipetting volume of 500

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 Specifications and Requirements

μL, plus the dead space volume of 200 μL. See the appropriate Aptima package
insert for more information.
Table 12. Panther System Dead Space Volume Requirements
Tube/Specimen Type Dead Space Volume Required

Aptima Specimen Transfer Tube 1300 μL

Aptima Urine Specimen Transport

1300 μL or 700 µL*
Tube – Urine specimens

Swab Specimen Transport Tube –

1300 μL
Unisex swab specimens

Swab Specimen Transport Tube –

1300 μL
Vaginal swab specimens

Cervical Specimen Collection and

1300 μL
Transport specimens

Multitest Swab Transport Tube 1300 μL

Primary Collection Tube – Plasma or

700 μL**
serum

Specimen Aliquot Tube (SAT) –

200 μL
Plasma or serum

*Dead space volume differs depending on assay. Refer to the appropriate assay
package insert for dead space volume requirements.
**1.2 mL above the pellet.

System Capacities and Throughput

Table 13. System Capacities and Throughput
Assay Reagent Kits Up to 4 assay reagent kits at a time

Universal Fluids Fluid Kit A and B – 2,000 tests

Up to 15 tubes per rack, up to 8 racks (120

Sample Racks
tubes)

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 Specifications and Requirements

Table 13. System Capacities and Throughput (Continued)

5 reaction tubes per MTU, up to 25 MTUs
MTU Drawer
(125 tests)

Pipette Tips 96 tips per rack, up to 6 racks (576 tips)

Liquid Waste Container 4.5 L (1.3 US gal), up to 750 tests

Solid Waste Container Up to 750 tests

3.5 hours for the first results; 5 results every 5

minutes thereafter for TMA assays
*System Throughput
2.7 hours for the first results; 5 results every 5
minutes thereafter for Real-Time assays

*Times are dependent on testing conditions.

Note—Results are available for review immediately following processing.

Operator Prerequisites
A qualified operator has the following:
l Proficient in laboratory practices, including training in handling hazardous
materials.
l Familiarity with the Panther System Operator's Manual.
l An understanding of the appropriate package inserts.
l Proper training on the Panther System by a qualified trainer, including
instructions on cleaning and maintaining the system.
l Assay and/or instrument proficiency may need to be demonstrated and
documented per laboratory procedure.

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 Overview

Overview
This section contains the following information:
l Technology Overview
l Panther System Overview
l Panther System Software Overview

Technology Overview
The Aptima assays are nucleic acid amplification tests that detect DNA or RNA from a
variety of approved specimen types and collection devices according to the appropriate
package insert.
Aptima assays may utilize the following proprietary technologies:
l Target Capture—Isolation and purification of nucleic acid from the sample.
l Transcription-Mediated Amplification (TMA®)—Amplification of target nucleic acid
to produce multiple copies of RNA for easier detection.
l Hybridization Protection Assay (HPA)—Detection of the amplified nucleic acid
using light-emitting nucleic acid probes.
l Dual Kinetic Assay (DKA)—Analysis of kinetic chemiluminescent data to
differentiate the presence of two signals in a single tube.
l Real-Time Assays—Assays that measure emission of fluorescence during the TMA
process.
l Internal Controls for Aptima Assays—May be used to control for nucleic acid
capture, amplification, and detection, as well as operator or instrument error.

Target Capture
The Target Capture process isolates nucleic acid of the target virus and purifies nucleic
acid for amplification.

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 Overview

Figure 2. Target Capture

1. An MTU is picked from the MTU Input Queue and placed in the sample dispense
station.
a. wTCR (that is kept in suspension by rotary mixing) is pipetted into the MTU tubes.
A single disposable tip is used to dispense TCR into all five reaction tubes within
an MTU.
b. Cooled sample is dispensed into each tube using individual pipette tips. Each
time a sample is dispensed, the pipettor verifies that both the wTCR and sample
have been dispensed accurately.
c. The distributor moves the MTU to the sample mix station where the fluids are
mixed.
d. The MTU moves to the High Temperature Incubator for target capture. At this
step, oligonucleotides called "capture oligos" hybridize to the target nucleic acid
sequence in the specimen. Cell lysis may also occur during this step for some
assays.
e. The MTU moves to the Transition Incubator, where the capture oligo/target
nucleic acid complexes hybridize to magnetic particles (beads) by their tail
sequences.
f. The MTU is cooled in a Chiller Ramp and moves into a parking slot where
magnets pre-capture magnetic TCR beads to the sides of the MTU wall.
2. Once the wTCR beads are captured, the MTU moves into the Magnetic Wash Station
Module (Mag Wash) where the captured target is separated from the residual fluids.
The Mag Wash goes through a process of injecting wash solution, mixing, capturing
particles, and aspirating residual solution to remove sample and wTCR residues.
3. The vacuum system is used for aspiration, ensuring optimal airflow and minimizing
aerosols. Following the final aspiration, oil is dispensed into the MTU to minimize
evaporation during the rest of the assay process.
4. When the Mag Wash cycle is complete, the purified target nucleic acid is ready to be
amplified by Transcription-Mediated Amplification.

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 Overview

Transcription-Mediated Amplification (TMA)

Transcription-Mediated Amplification (TMA) uses two enzymes, Reverse Transcriptase,
and RNA polymerase, to produce billions of copies of RNA amplified target from the
purified target nucleic acid.
The amplification process takes approximately one hour.
1. The MTU is transferred to the AMP load station where Amplification Reagent is
pipetted into each tube and mixed.
2. The MTU is transferred back to the High Temperature Incubator for the primer anneal
step, which promotes the binding of the primers to the target nucleic acid.
3. The MTU moves to the Transition Incubator to cool before Enzyme Reagent addition.
4. The MTU moves to the AMP load station. The pipettor adds Enzyme Reagent. The
MTU is mixed and transferred to the AMP/RT Incubator for amplification at 42.7 °C.
a. Reverse Transcriptase uses the primers to create a DNA copy of the target RNA.
If the target is DNA, the process skips to Step d.
b. The RNase H activities of reverse transcriptase degrade the original target RNA.
c. The second primer binds to the new DNA copy and reverse transcriptase creates
a double-stranded DNA duplex.
d. The RNA polymerase, through transcription, makes multiple RNA copies of the
DNA template.
e. The process repeats until the reagent supply is exhausted.
5. The amplified RNA, called "amplicon," is ready to be hybridized with the labeled
nucleic acid probe in the Hybridization Protection Assay.

Hybridization Protection Assay (HPA)

The Hybridization Protection Assay (HPA) process hybridizes the amplicon to single-
stranded nucleic acid probes that are labeled with an acridinium ester (AE) molecule and
then it selects and detects the hybridized probes.

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 Overview

Figure 3. Hybridization Protection Assay

1. The system moves the MTU into the HPA load station. The pipettor dispenses Probe
Reagent into each tube and the station mixes the tube contents.
The Probe Reagent contains AE-labeled oligonucleotides. The sequence of the
probes specifically complements the target amplicon.
If present, the amplicon hybridizes to the probes.
2. The MTU moves to the High Temperature Incubator for hybridization.
3. Once hybridized, the MTU moves to the HPA load station for addition of Selection
Reagent and mixing.
4. The MTU moves back to the High Temperature Incubator for the selection process.
During the selection phase, the hybridized and unhybridized probes are
differentiated by inactivating the AE label on the unhybridized probes. During
detection, the chemiluminescent signal produced by the hybridized probe is
measured in a luminometer and is reported as relative light units (RLUs). Inactive AE
does not emit light in the detection process.
5. The system dispenses Auto Detect 1 and Auto Detect 2 into the MTU. Auto Detect 1
and 2 react with the AE molecule, emitting a photon, or light signal.
6. A luminometer reads the light signal, if present.
7. After the luminometer reads the AE molecule signal, the MTU moves to the Output
Queue. The system injects sodium hypochlorite and Buffer for Deactivation into the
MTU to destroy any amplicon present. The MTU remains in the queue for 15 minutes
to decontaminate. The system then aspirates the fluids to a Liquid Waste Container
and deposits MTUs, pipette tips, and tiplets in a Solid Waste Container.

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Dual Kinetic Assay (DKA)

Aptima assays may also utilize the Dual Kinetic Assay (DKA) technology to enable
multiplex detection from a single sample. In DKA, differences in the kinetic profiles of
labeled probes allow for the differentiation of signal; kinetic profiles are derived from
measurements of photon output during the detection read time. When the
chemiluminescent detection reaction for the signal has very rapid kinetics, it is referred to
as a "flasher" kinetic type. When the chemiluminescent detection reaction for the signal is
relatively slower, it is referred to as a "glower" kinetic type.

Real-Time Assays
Real-time assay technology utilizes the target capture and the Transcription-Mediated
Amplification processes. Once the enzyme reagent is added, the progress of the
amplification is continually monitored with fluorescence detection. Several target nucleic
acids can be monitored and specifically identified, based on the wavelength of the
fluorescent molecule. The amplification reagent contains fluorescently labeled
oligonucleotides (torches) that have the two ends hybridized together (hairpin loop). On
one end is the fluorescent label and the other end has a quencher molecule. When the
two ends are in close proximity, the quencher molecule prevents the fluorescent light from
being released. During amplification, as the amplicon is being produced, the torch
hybridizes to the amplicon. When the torch is hybridized, the quencher is no longer next
to the fluorescent molecule, thereby allowing fluorescent light to be emitted. As the
amplification continues, the amount of bound torch reaches the detection threshold of the
fluorescence detector.

Internal Controls for Aptima Assays

Aptima assays may use an Internal Control to control for nucleic acid capture,
amplification, and detection, as well as operator or instrument error. Internal control is
added to each reaction. Internal Control signal in each reaction is discriminated from the
target signal.

Panther System Overview

Introduction
The Panther System is an integrated nucleic acid testing system that fully automates all
steps necessary to perform Hologic assays from sample processing through amplification,
detection, and data reduction.

Instrument Overview
The Panther System consists of the instrumentation and computer together in a single
unit. The instrument is operated via the touch-screen monitor that is connected to the
system. Communication with the instrument is controlled through a number of processing
boards known as the Communication and Organization Processor (COP). The COP is

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used to direct the operation of the subsystems to perform the assay steps, as well as
accommodating LIS connectivity and remote user access.
The Panther System is composed of four main areas:
l Canopy
l Panther Upper Bay
l Panther Mid Bay
l Panther Lower Bay

Figure 4. Panther System

Table 14. Panther System Components

Location Description

1. Canopy

2. Upper Bay

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Table 14. Panther System Components (Continued)

Location Description

3. Mid Bay

4. Lower Bay

Canopy

Figure 5. Canopy
Table 15. Canopy Location Descriptions
Description

1. Top Left LED

2. Top Right LED

3. Panther Top Canopy Panel

4. Monitor

5. Panther Left Canopy Door

6. Panther Right Canopy Door

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The smoked plexiglass canopy houses the pipettor architecture. The Touch-Screen
Monitor, connected to the right side of the canopy, is used to navigate the Panther System
Software.

Panther Upper Bay Components

The Panther Upper Bay consists of the following components:
l Reagent Bay and Reagent Barcode Reader
l Tip Drawers (2)
l Sample Bay and Sample Barcode Reader
l Target Capture Reagent (TCR) Carousel
l Panther Pipettor System
l Fluid Pumps

Figure 6. Panther Upper Bay

Table 16. Panther Upper Bay Descriptions
Location Description

1. Vacuum Manifold

2. Oil Pump

3. Wash Pump

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Table 16. Panther Upper Bay Descriptions (Continued)

Location Description

4. Auto Detect 1 Pump

5. Auto Detect 2 Pump

6. Deactivation Pump (Peristaltic)

7. TCR Carousel

8. Sample Bay

9. Tip Drawer 1

10. Tip Drawer 2

11. Reagent Bay

12. Reagent Barcode Reader

Reagent Bay

Figure 7. Reagent Bay

The Reagent Bay is a liquid-cooled storage bay that holds up to four (4) racks of reagents.
The internal reagent barcode reader identifies the reagent racks and reagent bottles as
they are loaded into the instrument. The reagents are housed in a cooled environment for
extended stability.

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Panther Tip Drawer Module

The Panther contains two (2) Tip Drawers. Each drawer holds three (3) trays of
disposable pipette tips. Each Tip Drawer has an interlock that ensures that the drawer
cannot be opened if in use during assay processing.

Sample Bay Module

Figure 8. Sample Bay Module

The Sample Bay is a liquid-cooled storage bay that holds up to eight (8) racks of samples.
Each Sample Rack has fifteen (15) positions to hold samples during assay processing.
The internal sample barcode reader identifies the sample racks and samples as they are
loaded into the instrument. The Sample Shield, found on top of the Sample Bay, prevents
any possible drips or mucoid strings from the pipettor from contaminating tubes within the
bay.

Target Capture Reagent (TCR) Carousel

The TCR carousel is an rotary mixer that mixes the TCR while onboard the instrument.
The carousel holds up to four (4) bottles of TCR and four (4) bottles of Target Enhancer
Reagent (TER). The TCR barcode reader scans all bottle positions in the TCR carousel,
verifying reagent placement and validity.

Note—Not all Aptima assays use TER.

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Panther Pipettor System

Figure 9. Panther Pipettor System

The Panther pipettor system consists of the pipettor robot and the pipettor arms. It is
composed of dual arm sample and reagent pipettor probes with integrated air based
pipettor pumps. The Panther pipettor system aspirates and dispenses the sample and
reagents during assay processing.

Fluid Pumps

The Fluid Pumps consist of the Auto Detect, Wash, Oil, and Deactivation pumps. These
pumps control the delivery of the universal fluids into each tube in the MTU.

Panther Mid Bay Components

The Panther Mid Bay consists of the following components:

l Incubators
l MTU Input Queue
l Distributor
l AMP Load Station
l HPA Load Station
l Magnetic Wash Stations
l Sample Mix Stations
l Luminometer
l Output Queue

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Figure 10. Panther Mid Bay

Table 17. Panther Mid Bay Descriptions
Location Description

1. Amp Load Station

2. HPA Load Station

3. Reagent Tip Eject

4. Magnetic Parking Slot 1

5. Magnetic Parking Slot 2

6. Magnetic Wash Station 1

7. Magnetic Wash Station 2

8. Sample Mix Station

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Table 17. Panther Mid Bay Descriptions (Continued)

Location Description

9. Sample Tip Eject

10. Sample Dispense Slot

11. Output Queue

12. Chiller Ramp Slots 1–6

13. Luminometer

14. Distributor

15. MTU Input Queue

16. AMP Incubator (Includes Fluorometer)*

17. High Temperature Incubator

18. Transition Incubator

*The Fluorometer is only included under certain system software configurations.

Incubators

The instrument contains three (3) incubators that are monitored and controlled by dual
internal thermistors. The incubators control the temperature of the MTUs during the assay
process.
The instrument contains the following incubators:
l High Temperature (Anneal) Incubator—Binds target nucleic acid to capture
oligonucleotides during Target Capture; Binds amplification primers to purified target
nucleic acid during TMA; Hybridizes AE-labeled probes to the amplicon during HPA
and destroys AE on unhybridized probes.
l Transition Incubator—Binds target nucleic acid to magnetic microparticles; Cools
the MTU before amplification; Cools the MTU after HPA and before entering the
luminometer.
l Amplification Incubator (AMP)—Amplifies targets during TMA. Attached beneath the
Amplification Incubator are the fluorometers used to detect fluorescent signals from
real-time assays.

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MTU Input Queue

The MTU Input Queue is used to load MTUs. A maximum of 125 tests worth of tubes (25
MTUs) can be loaded onto the instrument.

Distributor

The Distributor transfers the MTUs to the various components located within the system.
Its transfer mechanism is based on a hook and rail system that pushes and pulls the
MTUs between the instrument modules.

AMP Load Station

The AMP Load Station is used for the addition of Amplification Reagent and Enzyme
Reagent into the MTUs during assay processing. This heated load station features an
orbital mixer that ensures proper mixing following reagent addition.

HPA Load Station

The HPA Load Station is used for the addition of Probe Reagent and Selection Reagent
into the MTUs during assay processing. This heated load station features an orbital mixer
that ensures proper mixing following reagent addition.

Magnetic Wash Module

The instrument contains two (2) Magnetic Wash Stations. The Magnetic Wash Stations
separate the bound target nucleic acid from potential inhibitors and cell debris. Each
wash station consists of fluid injectors that dispense Wash Solution into the MTU tubes,
aspirators that draw the supernatant from the tubes, and a magnet carriage that separates
the target nucleic acid/magnetic particle complex from the test solution. The wash stations
also dispense oil into the MTUs following the wash cycle.

Sample Mix Station

The Sample Mix Station is used for the addition of sample and working Target Capture
Reagent (wTCR) to the MTUs. It features an orbital mixer that ensures proper mixing of
the sample and wTCR.

Luminometer

The Luminometer measures the chemiluminescent reaction triggered by the addition of

Auto Detect fluids to each tube of the MTU. The luminescence is measured with a
photomultiplier tube (PMT).

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Output Queue

The Output Queue performs deactivation of each reaction by injecting sodium

hypochlorite solution and Deactivation Buffer into each tube of the MTU. After
deactivation, the aspirators transfer the residual liquid to the Liquid Waste Container.

Panther Lower Bay Components

The Panther Lower Bay contains the following components:
l Computer
l Panther Waste Drawer
l Panther Universal Fluids Drawer
l NaOCl Bottle
l Vacuum System

Figure 11. Panther Lower Bay

Table 18. Panther Lower Bay Descriptions
Location Description

1. Power Supply

2. Solid Waste Container

3. Vacuum Pump

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Table 18. Panther Lower Bay Descriptions (Continued)

Location Description

4. Cooling Module

5. Bottle Status Panel

6. Oil Bottle B

7. Oil Bottle A

8. Auto Detect 1 Bottle B

9. Auto Detect 1 Bottle A

10. Auto Detect 2 Bottle B

11. Auto Detect 2 Bottle A

12. Wash Bottle A

13. Wash Bottle B

14. Deactivation Buffer Bottle A

15. Deactivation Buffer Bottle B

16. NaOCl Bottle

17. Coalescing Bottle

18. Liquid Waste Filter

19. Liquid Waste Bottle

20. Computer

21. Power Switch

Computer

The computer is housed in the lower left of the Panther System. The Panther System
Software launches automatically once the computer is powered on. When powering on,

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turn on the Panther System before turning on the computer to avoid communication
errors.

Panther Waste Drawer

The Panther Waste Drawer contains the Liquid Waste Container, Liquid Waste Filter,
Coalescing Bottle, and Solid Waste Container.

Liquid Waste Container

The Liquid Waste Container, located in the front of the Waste Drawer, collects the liquid
waste from the Magnetic Wash Station and the Output Queue. The Liquid Waste Filter
and Coalescing Bottle prevent the aspiration of liquid into the vacuum.

Solid Waste Container

The Solid Waste Container, located behind the Liquid Waste Container in the waste
drawer, captures used MTUs, mag wash tiplets, and pipettor tips.

Panther Universal Fluids Drawer

The Panther Universal Fluid Drawer holds two (2) sets of the following fluids:
l Wash Solution
l Auto Detect 1

l Auto Detect 2

l Oil

l Buffer for Deactivation

The fluids in the drawer are identified upon loading by a radio frequency identification
system (RFID) that reads the lot and expiration information for each bottle. A Bottle Status
Panel monitors the presence of each bottle through corresponding LEDs that are
connected to the RFID antennae inside the drawer lining. Sensors located behind the
lining also monitor the presence of fluid in each of the fluid lines.

NaOCl Bottle

The NaOCl Bottle, located in the Universal Fluid Drawer, holds the 5.0%–7.0% sodium
hypochlorite solution that is used for deactivation.

Vacuum Pump

The Vacuum System consists of the pump, filter, Coalescing Bottle, Liquid Waste Bottle,
Manifold, Digital Pressure Sensor, and associated tubing. The Vacuum System draws the
liquid waste from the Magnetic Wash Stations and Output Queue into the Liquid Waste
Container.

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Printer

The Panther System printer can be used to print all Panther System reports. It is possible
to connect the printer to the system through the site's network. Contact Hologic personnel
to assist with networking the printer.

Panther System Software Overview

Introduction
The Panther System Software is provided for use with the system. Use the touch-screen
monitor to navigate the software. The software loads automatically when the computer is
powered on.

Accessing the Panther System Software

Desktop Shield
Use the Desktop Shield to access the Panther System Software and the database
management functionality. The Desktop Shield screen opens after the computer powers
on. The system software starts automatically within 25 seconds if no buttons are selected
on the screen.

Figure 12. Desktop Shield Screen (Example)

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Login Screen
Use the Login screen to log into the system software. The Login screen opens after the
system powers on or after logging off the software.

Figure 13. Login Screen (Example)

Table 19. Login Screen Interactive Item Descriptions

Interactive Item Description

1. User Name Select this field to enter the operator user name
during login.

2. Password Select this field to enter the operator password

during login.

Navigating the Software

Interactive buttons, status bars, and icons are displayed on every screen to provide
access to all system functions and information required to operate the system. The
buttons, status bars, and icons can be found grouped either in the Menu Bar or Status
Panel or as an interactive item on every screen.

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Figure 14. Screen Locations (Example)

Table 20. Universal Screen Interactive Item Descriptions
Interactive Item Description

1. Menu Bar Use the Menu Buttons at the top of the screen for
navigating the software (see Menu Bar on page 45).

2. Screen Name The name of the current screen. If configurations

were changed that require a restart, a Restart
Needed message will appear.

3. Status Panel A panel of information including consumable

inventory panels, system activity updates, user
name ID, status icons, the date and time, and the
Print Screen button (see Status Panel on page 47).

4. Tip Count The number of pipette tips remaining and the status
of the Tip Drawers (see Tip Count on page 48).

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Table 20. Universal Screen Interactive Item Descriptions (Continued)

Interactive Item Description

5. System Activity Activity information and time of completion when

system tasks are being performed (see Status Panel
on page 47).

6. MTUs The number of MTU tests remaining and the status

of the MTU Input Queue (see MTUs on page 48).

7. User Name User name of the operator currently logged onto the
system (see Status Panel on page 47).

8. Waste The waste capacity in tests remaining and the

status of the Panther Waste Drawer (see Waste on
page 48).

9. Status Icons A series of icons representing the current status of

multiple system functions (see Additional Status
Panel Icons on page 49).

10. Fluid Kit A The remaining Universal Fluid tests for Fluid Kit A
and the status of the Panther Universal Fluid
Drawer (see Fluid Kit A on page 48).

11. Fluid Kit B The remaining Universal Fluid tests for Fluid Kit B
and the status of the Panther Universal Fluid
Drawer (see Fluid Kit B on page 48).

12. Date and Time Date and time (see Status Panel on page 47).

13. Select this button to print the current screen image

Print Screen (see Print Screen Button on page 50).

14. Located on screens with tables, select this button to

Selection assist with the selection of rows in a table (see
Selection Button on page 47).

15. State Indicator Current operating state (see Monitoring the State
Indicator on page 134).

Menu Bar
The Menu Bar is located at the top of every screen. Use the buttons on the Menu Bar to
navigate through the system software.

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Figure 15. Menu Bar (Example)

A description of the software controls can be found in the following table.
Table 21. Menu Button Descriptions
Menu Button Description
Back Select this button to return to the previous screen.

Messages Select this button to access the Messages screen.

Pending Select this button to access the Pending screen.

Tasks Select this button to access the Tasks screen.

Run Status Select this button to access the Run Status screen.

Test Orders Select this button to access the Test Orders screen.

Results Select this button to access the Results screen.

Reports Select this button to access the Report Menu screen.

Admin Selection this button to access the Administration screen.

Help Select this button for a direct link to the Help window.

Logoff Select this button to access the Logoff/Shutdown screen.

Interactive Items
Additional interactive items are accessible on every screen. These items provide
additional information required to operate the system.
Table 22. Interactive Item Descriptions
Status Bar Meaning of Information on Status Bar

Screen Name Indicates the current screen displayed.

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Status Bar Meaning of Information on Status Bar

State Indicator Indicates the current state of the system. Provides

information on the availability of the system for any activity.

Selection Button Provides selection menu to select the desired rows on the
current screen.

Selection Button

The Selection button is located on screens with tables, at the top-right of the vertical
scroll bar. Select the Selection button to access the Row Selection menu.

Figure 16. Row Selection Menu (Example)

Select a button on the Row Selection menu to choose the method for selecting rows on
the current screen.
Table 23. Row Selection Menu Buttons
Buttons Functionality

All Select this button to select all rows in the table.

Range Select this button to select a range of rows in the table. After
choosing this button, select the bottom and top rows of the
range desired, in any order, on the table.

Multiple Select this button to select rows in the table cumulatively.

Single Select this button to select a single row at a time in the

table. This is the default option upon startup.

Unselect Select this button to unselect the rows in a table.

Status Panel
The Status Panel is located at the bottom of every screen. The Status Panel is located at
the bottom of every screen. The panel is composed of Status Bars, Status Icons, and
additional items to provide information on inventory of consumables, system activity
updates, username ID, and date/time.

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Figure 17. Status Panel (Example)

Status Panel Bars

The Status Panel Bars within the Status Panel are used to load consumables, manage
waste and fluids, and to track inventory.
Table 24. Status Bar Updates
Status Bar Meaning of Information on Status Bar

Tip Count Select this bar to load tips.

MTUs Select this bar to load MTUs.

Waste Select this bar to access the Waste Management

screen.

Fluid Kit A Select this bar to access the Universal Fluid Bay
screen.

Fluid Kit B Select this bar to access the Universal Fluid Bay
screen.

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Additional Status Panel Icons

The Status Icons at the bottom right of the Status Panel alert the operator to when certain
components or connections are not functioning properly. Icons with a red strike-through
indicate that a component is not functioning within specification or is not in a state
necessary for transition into assay processing. Unmarked icons indicate that the
component is functioning normally.
Table 25. Additional Status Icon Descriptions
Icon Meaning of Icon

Temperature—Status of the internal temperature and incubator

temperatures.

Vacuum—Status of the vacuum pressure.

Doors—Status of the doors and drawers.

USB Drive—The icon is displayed when a USB drive has been

inserted and is recognized by the system.

LIS—The icon is displayed when the system is connected to an

LIS.

Remote Diagnostics—The icon is displayed when a Hologic

specialist is connected to the system during a Remote Diagnostic
Session. Selecting this icon transitions the operator to the PRO360°
Software window.

UPS—The icon is displayed when the Enable UPS Shutdown

functionality is enabled. Selecting this icon displays the charge
status of the connected UPS.

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Table 25. Additional Status Icon Descriptions (Continued)

Icon Meaning of Icon

Printer—Status of the printer.

Comments—The icon is displayed when a message is available

on the Comments screen. The Comments screen may be accessed
from the Messages screen.

Additional Status Panel Items

Additional items displayed at the bottom of the Status Panel provide information about the
user, date/time, and current system activity. A button above the date/time is also available
for printing screens.

Table 26. Additional Status Panel Items

Interactive Item Description

System Activity Displays the current system task that is currently being
performed and the time to completion.

User Name Displays the user name of the operator that is currently
logged into the system.

Date and Time Displays the current date and time.

Print Screen Located at the right side of the Status Panel. Select the
Button Printer button to print the current screen. Insert a USB drive
and select the Printer button to save a screen capture image
to the drive. The file will appear in Panther Images folder in
the drive with the following naming convention:
ScreenCapture_ YYYYMMDD_HHMMSS*.jpg
*The date and time represent the time that the file was
created.

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Panther System Software Screens

The following section provides an overview of the information and functions available on
the following main screens.

l Desktop l Waste
l Run Status l LIS Configuration
Shield Management
l Maintenance
l Login l Test Orders l Operator Management
Activities
l Assay
l Messages l Results l Change Password
Reagent Bay
l Assay
l Quality Control
l Comments Reagent l Report Menu
Configuration
Loading
l Sample l Reflex Testing
l Pending l Administration
Rack Bay Configuration
l Sample l Assay Custom Cutoff
l Data
l Tasks Rack Value Configuration
Management
Loading Screen
l Universal l Sample l System
l Help Window
Fluid Bay Details Configuration
l Logoff/Shutdown

Desktop Shield Screen

The Desktop Shield screen can also be used to backup the database, restore the
database, delete a saved version of the database, or shut down the computer.

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Figure 18. Desktop Shield Screen (Example)

Table 27. Desktop Shield Screen Button Descriptions

Button Description

1. Panther Select this button to start the Panther System

Software.

2. Backup Select this button to access the database backup

functionality (see Database Backup on page 211).

3. Restore Select this button to access the restore database

functionality (see Database Restore on page 212).

4. Delete Database Select this button to access the delete database

functionality (see Delete Database on page 212).

5. Remote Select this button to activate the PRO360° software.

Diagnostics This task should be used in conjunction with Hologic
Technical Support assistance as part of
troubleshooting system issues. Refer to the Remote
Diagnostics section for further information on how to
perform this task (see Troubleshooting on page 254).

6. Shutdown Select this button at the lower right corner of the

screen to shut down the computer.

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Messages Screen
Access the Messages screen by selecting the Messages button on the Menu Bar. The
Messages screen is always available independent of login status.
Use the Messages screen to view system generated messages and to perform
troubleshooting tasks. View messages at any time the instrument is not in the Initialization
state. Use the filters at the top of the table to configure the message display as needed.

Figure 19. Messages Screen (Example)

Table 28. Message Screen Descriptions
Interactive Item Description

1. Date/Time The time that the message was generated (sorted

with most recent messages at the top of the table).

2. Severity The category of the message. The message severity

can fall into one of the following categories:
Error—System error occurred that requires operator
intervention.
Warning—System event occurred that may
necessitate operator intervention.
Info—Informational system message.

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Table 28. Message Screen Descriptions (Continued)

Interactive Item Description

3. Event ID Specific error code for message.

4. Description Explanation of system event that occurred.

5. Clear Select this button to remove selected messages from

the Messages screen.

6. Clear All Select this button to remove all messages from the
Messages screen.

7. Silence Alarm Select this button to silence any audible alarms.

8. Remote Select this button to activate the PRO360° software.

Diagnostics This task should be used in conjunction with Hologic
Technical Support assistance as part of
troubleshooting system issues. Refer to the Remote
Diagnostics section for further information on how to
perform this task (see Troubleshooting on page 254).

9. Send Logs Select this button to export system log files. This task
should be used in conjunction with Hologic
Technical Support assistance as part of
troubleshooting system issues. Refer to the Send
Logs section for further information on how to perform
this task (see Send Logs on page 259).

10. Comments Select this button to access the Comments screen

and add or delete comments (see Comments Screen
on page 54).

11. Shutdown Select this button to shut down the system. The
Shutdown button is only available when the system
is safe to shut down.

Comments Screen
Access the Comments screen by selecting the Comments button on the Messages
screen (see Messages Screen on page 53).
Use the Comments screen as a notepad to leave notes for later viewing. The comment
text must be between three (3) and 300 characters. Use the Date/Time, User Name, or
Comment column headers at the top of the table to sort the posted comments as needed.
Once a note is added, a comments icon will be displayed in the Status icons location on

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the bottom of the screen. The system automatically deletes all previously read comments
when the system is shut down and restarted.

Figure 20. Comments Screen (Example)

Table 29. Comments Screen Descriptions
Button Description

1. Add Select this button to add comments.

2. Delete Select a comment and then select this button to

delete the chosen comment(s).

Pending Screen
To access the Pending screen:
l Select the Pending button on the Menu Bar (see Menu Bar on page 45).
Monitor the Pending screen for tasks that are needed to begin processing associated
samples. Pending tasks are generated for any incomplete task or condition necessary for
the system to initiate or continue sample processing.
The Pending button flashes yellow and System LEDs flash green when new pending
notifications are generated. The red number on the Pending icon represents the number
of notifications present on the screen.

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Figure 21. Pending Screen (Example)

From the Pending screen, select an item in the Description column to be automatically
directed to the screen associated with the notification. The notification will be removed
from the Pending screen once the item has been addressed.

Tasks Screen
To access the Tasks screen, select the Tasks button on the Menu Bar. The Tasks screen
automatically opens after logging into the system.
Use the buttons on the Tasks screen to prepare the system for assay processing.

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Figure 22. Tasks Screen (Example)

Table 30. Tasks Screen Buttons
Task Button Description

1. Load Tips Select this button to initiate the tip loading process
(see Load Tips on page 94).

2. Load MTUs Select this button to initiate the MTU loading process
(see Load MTUs on page 97).

3. Load Universal Select this button to access the Universal Fluid Bay
Fluids screen (see Load Universal Fluids on page 98).

4. Empty Waste Select this button to access the Waste Management

screen (see Empty Waste on page 101).

5. Perform Select this button to access the Maintenance

Maintenance Activities screen (see Maintenance Activities Screen
on page 190).

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Table 30. Tasks Screen Buttons (Continued)

Task Button Description

6. Prime Instrument Select this button to initiate a system prime (see

Prime Instrument on page 104).

7. Load Assay Select this button to access the Assay Reagent Bay
Reagents screen (see Load Panther Assay Reagents on page
106).

8. Load Samples Select this button to access the Sample Rack Bay
screen (see Load Samples on page 113).

Universal Fluid Bay Screen

To access the Universal Fluid Bay screen:

l Select the Load Universal Fluids button on the Tasks screen (see Tasks Screen on
page 56).
l Select the Fluid Kit A or Fluid Kit B inventory status panel (see Status Panel on page

47).
l Open the Panther Universal Fluid Drawer.

The Universal Fluid Bay screen provides current inventory, expiration and kit validity
information for loaded universal fluids. Refer to the bottle display for a status update when
refreshing the fluid inventory. For more information, see Load Panther Universal Fluids on
page 98.

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Figure 23. Universal Fluid Bay Screen (Example)

Table 31. Universal Fluid Bay Screen Descriptions
Screen Locations Description

1. Kit A Panel Universal fluid information pertaining to Fluid Kit A.

2. Kit B Panel Universal fluid information pertaining to Fluid Kit B.

3. Prime Panel The time remaining before prime validity expires.

Waste Management Screen

To access the Waste Management screen:

l Select the Empty Waste button on the Tasks screen (see Tasks Screen on page 56).
l Select the Waste inventory status panel (see Status Panel on page 47).

The Waste Management screen provides the remaining capacity of the Panther System
waste containers. Refer to the container display for a status update when refreshing the
waste capacity. For more information, see Emptying Panther Waste on page 101.

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Figure 24. Waste Management Screen (Example)

Table 32. Waste Management Screen Descriptions
Screen Locations Description

1. Total Waste The remaining tests available for the Liquid and
Solid Waste Containers.

2. Solid Waste Status information associated with the Solid Waste

Status Container.

3. Liquid Waste Status information associated with the Liquid Waste

Status Bottle.

4. Unlock Waste Select this button to unlock the Panther Waste

Bay Drawer.

Maintenance Activities Screen

To access the Maintenance Activities screen, select the Perform Maintenance button on
the Tasks screen (see Tasks Screen on page 56).
Refer to the Maintenance Activities screen for the status of maintenance tasks and for
managing maintenance procedures.

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Figure 25. Maintenance Activities Screen (Example)

Table 33. Maintenance Activities Screen Descriptions
Screen Location Description

1. Maintenance Table listing information pertaining to Panther

Activities Table System maintenance tasks including the date and
time of scheduled maintenance tasks (see General
Maintenance Information on page 189).

2. Start Select this button to access the Run Maintenance

Task screen (see Maintenance Activities Screen on
page 190).

3. Edit Select this button to access the Edit Maintenance

Task screen (see Schedule an Automated
Maintenance Task on page 193).

4. Details Select this button to access the Maintenance Task

Details screen (see Maintenance Task Details
Screen on page 191).

5. Force Full Prime Select this button to perform a full prime (see Force
Full Prime on page 106).

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Table 33. Maintenance Activities Screen Descriptions (Continued)

Screen Location Description

6. Force MTU Select this button to search for and remove all MTUs
Unload from the system (see Force MTU Unload on page
258).

7. LIS Messages For systems connected to an LIS, select this button to

view all messages sent to and received from the LIS
(see LIS Messages on page 239).

Assay Reagent Bay Screen

To access the Assay Reagent Bay screen:

l Select the Load Assay Reagents button on the Tasks screen (see Tasks Screen on
page 56).
l Open the Reagent Bay Door.
Use the Assay Reagent Bay screen during the assay reagent loading process. For more
information, see Load Panther Assay Reagents on page 106.

Figure 26. Assay Reagent Bay Screen (Example)

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Table 34. Assay Reagent Bay Screen Descriptions

Screen Location Description

1. Reagent Rack Graphical display of the four (4) lanes of the Reagent
Graphic Bay.

2. Rack Details/Edit Select this button to access the Assay Reagent

Loading screen (see Assay Reagent Loading Screen
on page 63).

3. Change Scan Select this button to focus the Reagent Bay Barcode
Lane Scanner on the selected Reagent Bay Lane.

4. New/Activate Lot Select this button to enter assay reagent Master Lot
information (see Add a New Master Lot on page
107).

5. Inactivate Lot Select this button to inactivate an assay reagent

Master Lot (see Inactivate a Master Lot on page 108).

6. Run New Select this button to require a new set of controls or

Ctrls/Cals calibrators for additional sample processing (see
Run New Controls/Calibrators on page 115).

7. TCR Carousel Graphical display of the four (4) positions of the TCR
Graphic Carousel.

Assay Reagent Loading Screen

To access the Assay Reagent Loading screen:

l Select the graphic of a Reagent Bay Lane on the Panther Assay Reagent Bay screen
(see Assay Reagent Bay Screen on page 62) and then select the Rack Details/Edit
button.
l Double-click on the Reagent Bay Lane graphic on the Panther Assay Reagent Bay
screen.
Operators are automatically directed to this screen if there is an assay reagent kit-related
error during the loading process.
Refer to the Assay Reagent Loading screen for specific Panther assay reagent kit
information.

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Figure 27. Assay Reagent Loading Screen (Example)

Table 35. Assay Reagent Loading Screen Descriptions

Screen Location Description

1. Reagent Bay Reagent Bay Lane number of the Reagent Rack.

Lane Number

2. Assay Reagent Information for the assay reagent kit loaded in the
Kit Panel selected Reagent Bay Lane.

3. Loaded Kits All loaded assay reagent kits and associated

Panel Reagent Bay Lanes.

4. Barcode and Reagent lot and status information for the reagents in
Status Table the kit.

Sample Rack Bay Screen

To access the Sample Rack Bay screen:

l Select the Load Samples button on the Tasks screen (see Tasks Screen on page
56).
l Select the Sample Rack graphics on the Run Status screen (see Run Status Screen
on page 70).
l Open the Sample Bay Door.

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Use the Sample Rack Bay screen during the sample loading process. For more
information, see Load Samples on page 113.

Figure 28. Sample Rack Bay Screen (Example)

Table 36. Sample Rack Bay Screen Descriptions
Screen Location Description

1. Sample Rack Graphical display of the eight (8) lanes of the Sample
Graphic Bay.

2. Pause Select this button to pause sample pipetting (see

Pausing Sample Pipetting on page 130).

3. Resume Select this button to resume sample pipetting (see

Resume Pipetting Following Pause on page 130).

4. Rack Details Select this button to access the Sample Rack

Loading screen (see Sample Rack Loading Screen
on page 66).

5. Change Scan Select this button to focus the Sample Barcode

Lane Scanner on the selected Sample Bay Lane.

6. Assign Reagent Select this button to assign a reagent lane to be used

Lane for processing the next sample rack that is loaded.

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Table 36. Sample Rack Bay Screen Descriptions (Continued)

Screen Location Description

7. *New Ctrl/Cal Lot Select this button to enter control/calibrator lot

information for designated assays (see Adding a
New Control/Calibrator Lot on page 113).

8. Lane Details Sample ID and associated assay test order

information for the samples loaded in a selected
Sample Bay Lane.

9. Set Select this button to choose the sample default

criteria.

10. Sample Defaults Current sample default criteria (see Sample Defaults
Panel on page 117).

*This button is only visible under certain system software configurations.

Sample Rack Loading Screen

To access the Sample Rack Loading screen:

l Select the graphic of a Sample Bay Lane on the Sample Rack Bay screen and then
select the Rack Details button.
l Double-click the Sample Bay Lane graphic of a loaded rack on the Sample Rack Bay

screen (see Sample Rack Bay Screen on page 64).

Operators are automatically directed to this screen during the loading process when
further operator input is needed. Several buttons on this screen are conditionally-
dependent and will only appear under certain loading scenarios. For example, External
Quality Control (EQC) buttons and reflex testing buttons will only be available if the
system is configured for these options and the selected Sample Rack contains tubes
associated with these testing categories.

The operator can also navigate to the Sample Rack Loading screen for adding test orders
for the entire Sample Rack, as well as designating STAT for all specimens in the Sample
Rack.

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Figure 29. Sample Rack Loading Screen (Example)

Table 37. Sample Rack Loading Screen Descriptions

Screen Location Description

1. Accept Rack Select this button to accept the rack and return to the
Sample Rack Bay screen.

2. Sample Select this button to access the Sample Details

Details/Edit screen (see Sample Details Screen on page 68).

3. STAT All Select this button to set priority to all the specimens
in the rack (see Scheduling STAT Test Orders on
page 126).

4. Add Test Orders Select this button to add test orders to all specimens
All in the rack (see Adding a Test Order on page 123).

5. Allow All Repeats Select this button to allow any specimen that has
already been processed to be tested as designated
(see Enable Detection and Flagging of Repeat
Barcodes/Reject All Repeat Test Orders on page
225).

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Table 37. Sample Rack Loading Screen Descriptions (Continued)

Screen Location Description

6. *Assign EQC Select the message in the Status column for the
relevant EQC then select this button to choose the
pre-defined EQC information (see Loading
Unlabeled Quality Controls on page 248).

7. *Select EQC Select the message in the Status column for the
Assays relevant EQC then select this button to choose the
assay type(s) (see Selecting Assays During EQC
Loading on page 249).

8. *Reflex All Select this button to assign reflex test orders to all
samples in the rack that have unresolved reflex
assay test orders (see Designating Reflex Tests
During Sample Rack Loading on page 253).

9. *Apply Dilution Select this button to assign a dilution factor to all

All quantitative samples in the rack (see Dilution Factors
on page 127).

10. SID and Status Sample ID and loading error status information for
Table each of the samples in the Sample Rack.

* These buttons are only visible under certain system software configurations.

Sample Details Screen

To access the Sample Details screen:

l From the Sample Rack Loading screen, select the Sample Details/Edit button.
l From the Sample Rack Loading screen, click on a tube (see Sample Rack Loading
Screen on page 66).
Refer to the Sample Details screen for test order status and for altering the test order
assignment for the sample.

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Figure 30. Sample Details Screen (Example)

Table 38. Sample Details Screen Descriptions

Screen Location Description

1. Selected Sample The tube location for the chosen sample is

highlighted on the Sample Rack graphic.

2. Sample Position Location of the sample in the Sample Rack.

3. Rack Position Location of the Sample Rack in the Sample Bay.

4. Process as Check this box to process the selected

Specimen control/calibrator as a specimen (see Running
Controls/Calibrators as Specimens on page 127).

5. Edit Sample ID Select this button to edit the Sample ID of a test order
with an auto-generated or manually entered SID.

6. STAT Test Order Select this button to schedule the selected test order
to be run in the next available MTU time slot (see
Scheduling STAT Test Orders on page 126).

7. Add Test Order Select this button to add test orders to the sample.

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Table 38. Sample Details Screen Descriptions (Continued)

Screen Location Description

8. Delete Test Order Select this button to delete test orders from the
sample.

9. *Apply Dilution Select this button to assign a dilution factor to the

selected test order.

10. Test Orders Table Test order, status and results flag information for the
sample.

* This button is only visible under certain system software configurations.

Run Status Screen

To access the Run Status screen, select the Run Status button on the Menu Bar (see
Menu Bar on page 45).
Use the Run Status screen to monitor reagents and samples during assay processing.

Figure 31. Run Status Screen (Example)

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Table 39. Run Status Screen Descriptions

Screen Location Description

1. Sample Bay Graphical display of the eight (8) lanes of the Sample
Status Bay. Selecting the Sample Rack graphics opens the
Sample Rack Bay screen (see Sample Rack Bay
Screen on page 64).

2. Assay Reagents Status of assay reagent kits and associated

Panel controls/calibrators that are currently loaded on the
system The panel displays the following information:
Kit—Assay of kit loaded in the corresponding
Reagent Bay Lane.
Tests—The number of tests remaining in the assay
reagent kit.
Kit Exp.—Amount of time remaining before the
assay reagent kit expires.

Ctrl/Cal. Status—The status of the control or

calibrator set associated with the assay reagent kit
(see Monitoring Control/Calibrator Status on page
149).
Expiration—Amount of time remaining before control
or calibrator set validity expires.

3. Results Panel Displays status of results during the time that the
system remains in the Assay Processing state. The
panel displays the following information:

Results—The number of results logged during the

current Assay Processing state.
Time for Next Result—The time that the next result
will be available.
Time for Last Result—The time that the result of the
last test order will be available.

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Table 39. Run Status Screen Descriptions (Continued)

Screen Location Description

4. Specimens Panel Displays status of test orders currently loaded on the

system. The panel displays the following information:
Loaded—The number of specimens loaded in the
Sample Bay.
Pending—The number of loaded specimens that
have an associated pending item. These test orders
cannot be run until the pending item(s) are
addressed.
No Test Order—The number of loaded specimens
that do not have an associated test order. These test
orders cannot be run until a test order is assigned.

Test Orders Screen

To access the Test Orders screen, select the Test Orders button on the Menu Bar (see
Menu Bar on page 45).
Refer to the Test Orders screen for information on test orders. Use the filter categories at
the top of the screen or select the column headers to sort the test orders as desired.

Figure 32. Test Orders Screen (Example)

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Table 40. Test Orders Screen Descriptions

Screen Location Description

1. Sort Categories Pre-defined categories to assist in sorting data for

viewing.

2. Delete Select this button to delete the test order.

3. Edit Select this button to edit the Sample ID of a test order

with an auto-generated or manually entered SID.

4. Fetch From LIS Select this button to download test orders from an
LIS.

Results Screen

To access the Results screen, select the Results button on the Menu Bar (see Menu Bar
on page 45).
Refer to the Results screen for test results information. Use the Filters button at the top of
the screen or select the column headers to sort the results as desired.

Figure 33. Results Screen (Example)

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Table 41. Results Screen Descriptions

Screen Location Description

1. Filters Select this button to define criteria to filter data in the

table (see Viewing Results on page 150).

2. Verify Select this button to verify selected test results (see

Verifying Results on page 155) if the Enable Result
Verification configuration is enabled from the Admin
screen.

3. Edit Sample ID Select this button to edit the sample ID of a test result
with an auto-generated or manually entered SID
(see Editing Auto-Generated or Manually Entered
Sample IDs on page 155).

4. Export Raw Data Select this button to export the kinetic data of
selected results (see Exporting Raw Data on page
157).

5. Export LIS Data Select this button to export the LIS data for the
selected results (see Exporting LIS Data on page
157).

6. Send results to Select this button to export the results data to the LIS
LIS (see Sending Results to LIS on page 158).

7. *Export Viral Data Select this button to export the data for the selected
real-time assay test order results (see Export Viral
Data on page 159).

8. *Curve Data Select this button to view the Sample Curve Report
for the real-time assay test order result (see Sample
Curve Report on page 152).

9. Details Select this button to view additional information for

the selected test result (see Result Details on page
153).

10. User Comment Select this button to add a note for the selected
invalid control or calibrator (see User Comment on
page 154).

* These buttons are only visible under certain system software configurations.

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Report Menu Screen

To access the Report Menu screen, select the Reports button on the Menu Bar (see
Menu Bar on page 45).
Refer to the Report Menu screen to create and access reports. Use the criteria at the right
of the screen to define the parameters for the desired report (see Reports Management on
page 159).

Figure 34. Report Menu Screen (Example)

Table 42. Report Menu Screen Descriptions

Screen Location Description

1. View Select this button to view the report as defined by the

report criteria (see Navigating Reports on page 163).

2. Print Select this button to print the report as defined by the

report criteria. It is also possible to print while viewing
the report (see Printing Reports on page 163).

3. Export Select this button to export the report as defined by

the report criteria. It is also possible to export while
viewing the report (see Exporting Reports on page
164).

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Table 42. Report Menu Screen Descriptions (Continued)

Screen Location Description

4. Report Criteria Define the parameters for the desired report. The
Panel report generated by the system will be based upon
these criteria (see Selecting Reports on page 162).

Administration Screen

To access the Administration screen, select the Admin button on the Menu Bar (see
Menu Bar on page 45).
Refer to the Administration screen for access to the screens for configuring the system
and operator settings. Use the buttons on the screen to access the corresponding
screens.

Figure 35. Administration Screen (Example)

Table 43. Administration Screen Button Descriptions
Screen Buttons Description

1. Data Select this button to access the Data Management

Management screen (see Data Management Screen on page 77).

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Table 43. Administration Screen Button Descriptions (Continued)

Screen Buttons Description

2. System Select this button to access the System Configuration

Configuration screen (see System Configuration Screen on page
79).

3. LIS Configuration Select this button to access the LIS Configuration

screen (see LIS Configuration Screen on page 80).

4. Operator Select this button to access the Operator

Management Management screen (see Operator Management
Screen on page 84).

5. Change Select this button to change the password for the

Password operator currently logged on to the system (see
Change Password on page 243).

6. Quality Control Select this button to access the Quality Control

Configuration Configuration screen (see Quality Control
Configuration Screen on page 85).

7. Reflex Testing Select this button to access the Reflex Testing

Configuration Configuration screen (see Reflex Testing
Configuration Screen on page 87).

8. Assay Custom Select this button to access the Assay Custom Cutoff
Cutoff Value Value Configuration screen (see Assay Custom
Configuration Cutoff Value Configuration Screen on page 89).

Data Management Screen

To access the Data Management screen, select the Data Management button on the
Administration screen (see Administration Screen on page 76).

Refer to the Data Management screen for purging the three (3) types of system logs and
the results logs. Use the available buttons on the screen to complete the corresponding
data management tasks.

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Figure 36. Data Management Screen (Example)

Table 44. Data Management Screen Button Descriptions
Screen Buttons Description

1. Auto Purge Select this button to alter settings for automatically

Activity Log purging activity logs (see Auto Purge Log
Config Configuration on page 216).

2. Auto Purge Select this button to alter settings for automatically

Maintenance Log purging maintenance logs (see Auto Purge Log
Config Configuration on page 216).

3. Auto Purge Select this button to alter settings for automatically

Message Log purging message logs (see Auto Purge Log
Config Configuration on page 216).

4. Auto Purge Select this button to automatically purge results from

Results Config the database (see Auto Purge Log Configuration on
page 216).

5. Purge Activity Select this button to manually purge activity logs from
Log the database (see Purge Logs on page 216).

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Table 44. Data Management Screen Button Descriptions (Continued)

Screen Buttons Description

6. Purge Select this button to manually purge maintenance

Maintenance Log logs from the database (see Purge Logs on page
216).

7. Purge Message Select this button to manually purge message logs

Log from the database (see Purge Logs on page 216).

8. Purge Results Select this button to purge results from the database
(see Purge Results on page 217).

System Configuration Screen

To access the System Configuration screen, select the System Configuration button on
the Administration screen (see Administration Screen on page 76).

Select any of the tabs on the User Configurable Settings menu to view the settings for the
corresponding functional area.

Figure 37. System Configuration Screen (Expanded Example)

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Table 45. System Configuration Screen Descriptions

Screen Locations Description

1. Instrument Serial The instrument serial number.

Number

2. User Select one of the items on the menu to expand the

Configurable display and view the associated configurable
Settings Menu settings (see Configuration on page 218).

3. Save Select this button to save any changes made to the

configuration settings.

LIS Configuration Screen

To access the LIS Configuration screen, select the LIS Configuration button on the
Administration screen (see Administration Screen on page 76).

Refer to the LIS Configuration screen to adjust the LIS settings.

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Figure 38. LIS Configuration Screen—General Settings (Example)

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Figure 39. LIS Configuration Screen—Serial Settings (Example)

Figure 40. LIS Configuration Screen—TCP/IP Settings (Example)

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Figure 41. LIS Configuration Screen—File Settings (Example)

Table 46. LIS Configuration Screen Location Descriptions

Screen Buttons Description

1. General Settings Select the options in this panel to configure

bidirectional transfer as needed (see LIS
Configuration on page 236). Selecting one of the
three (3) Interface Layer categories opens the
specific configuration setting menu on the screen.

2. Serial Settings Select the options in this panel for optimal LIS
communication when using a serial connection (see
LIS Configuration on page 236).

3. TCP/IP Settings Select the options in this panel for optimal LIS
communication when using a TCP/IP connection
(see LIS Configuration on page 236).

4. File Settings System directories for messages sent to and

received from the LIS (see LIS Configuration on page
236). These directories are only accessible by
Hologic personnel.

5. Save Select this button to save configurations.

6. Start Select this button to enable LIS connection.

7. Stop Select this button to disable LIS connection.

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Operator Management Screen

To access the Operator Management screen, select the Operator Management button
on the Administration screen (see Administration Screen on page 76).
Refer to the Operator Management screen to add, delete, and edit operator account
settings.

Figure 42. Operator Management Screen (Example)

Table 47. Operator Management Screen Location Descriptions
Screen Locations Description

1. Add Select this button to add an operator account (see

Adding Operator Accounts on page 240).

2. Edit Select this button to edit the selected operator

account (see Editing Operator Accounts on page
242).

3. Delete Select this button to delete the selected operator

account (see Deleting Operator Accounts on page
243).

Change Password

To access the Change Password window, select the Change Password button on the
Administration screen (see Administration Screen on page 76).

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Quality Control Configuration Screen

To access the Quality Control Configuration screen, select the Quality Control
Configuration button on the Administration screen (see Administration Screen on page
76).
Use the Quality Control Configuration screen to add or delete external quality controls
and/or set the mean and standard deviation values on Levey-Jennings reports for
manufacturer controls. Once a quality control is added or updated, the corresponding tab
on the screen displays the control's entered information (see Quality Control
Configuration on page 244).

Figure 43. Quality Control Configuration Screen—External Quality Controls Tab

(Example)
Table 48. Quality Control Configuration Screen Button Descriptions (External
Quality Controls Tab)
Screen Buttons Description

1. Add Select this button to create a new external quality

control.

2. Edit Select a quality control from the table and then

select this button to edit/view the information for the
chosen external quality control.

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Table 48. Quality Control Configuration Screen Button Descriptions (External

Quality Controls Tab) (Continued)
Screen Buttons Description

3. Copy Select a quality control from the table and then

select this button to create a copy of the chosen
external quality control.

4. Delete Select a quality control from the table and then

select this button to delete the chosen external
quality control from the table.

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Figure 44. Quality Control Configuration Screen—Manufacturer's

Controls/Calibrators Tab (Example)
Table 49. Quality Control Configuration Screen Button Descriptions
(Manufacturer's Controls/Calibrators Tab)
Screen Buttons Description

1. Add Select this button to override the mean and

standard deviation values on the Levey-Jennings
Report for a manufacturer control/calibrator.

2. Edit Select a control/calibrator from the table and then

select this button to edit the mean and standard
deviation values for the chosen manufacturer
control/calibrator.

3. Delete Select a control/calibrator from the table and then

select this button to delete the override values for
the selected quality control/calibrator.

Reflex Testing Configuration Screen

To access the Reflex Testing Configuration screen, select the Reflex Testing
Configuration button on the Administration screen (see Administration Screen on page
76).

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Use the Reflex Testing Configuration screen to configure the reflex testing settings. From
this screen the user can select the result condition that will automatically generate a reflex
test for designated specimens (see Reflex Testing Configuration on page 251).

Figure 45. Reflex Testing Configuration Screen (Example)

Table 50. Reflex Testing Configuration Screen Button Descriptions

Screen Locations Description

1. Enable Reflex Check this cell to configure the system to

Testing automatically apply a reflex test order to specimens if
their result matches the result interpretation. See the
description for the Select at Rack Load below for
additional information.

2. Select at Rack This cell is only available after the Enable Reflex
Load Testing cell has been checked.
Check this cell to configure the system to guide
operators to select specimens during Sample Rack
loading that are to be assigned reflex test orders
following testing.

3. Save Select this button to save changes made to the reflex

testing configuration settings.

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Assay Custom Cutoff Value Configuration Screen

For additional information, refer to the appropriate Panther System Software Application
Sheet.

Help Window
To access the Help window, select the Help button on the Menu Bar (see Menu Bar on
page 45).
Select the Help button to access the section of the Panther System Operator’s Manual
that refers to the current screen. Use the instructions in the manual for assistance or
troubleshooting purposes. The entire operator’s manual is available for viewing through
this window. Select the Help button on the menu bar to return to the current screen.

Figure 46. Help Window (Example)

Table 51. Help Window Buttons
Screen Locations Description

1. Home Select this button to access table of contents for the

online Help.

2. Back Select this button to scroll to previous page already

visited.

3. Forward Select this button to scroll ahead to a page already

visited.

4. Print Select this button to print the current section of the

online Help.

5. Previous Page Select this button to go to the previous page in the

online Help.

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Table 51. Help Window Buttons (Continued)

Screen Locations Description

6. Next Page Select this button to go to the next page in the online
Help.

7. Contact Info Select this button to display Hologic contact

information.

8. Print (PDF) Select this button to open a pdf version of the

Panther System Operator's Manual on the screen.

9. Contents Use this function to navigate to specific sections

within the online Help.

10. Search Use this function to locate exact matches for words
entered in the search query.

11. About Select this button to list the version information of

system software, firmware, and assay software.

Logoff/Shutdown Screen
To access the Logoff/Shutdown screen, select the Logoff button on the Menu Bar (see
Menu Bar on page 45).
Use the Logoff/Shutdown screen to log off the Panther System Software or to shut down
the computer. Do not log off the system before shutting down.

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Figure 47. Logoff/Shutdown Screen (Example)

Table 52. Logoff/Shutdown Screen Buttons
Screen Buttons Description

1. Logoff Select this button to log off the Panther System

Software (see Logoff on page 93).

2. Instrument Select this button to shut down the computer (see

Shutdown System Startup on page 92).

3. Enter Power Save If the Power Save mode is enabled, select this button
to enter the Power Save state (see Power Save
Management on page 232).

4. Exit Power Save If the Power Save mode is enabled, select this button
to exit the Power Save state (see Power Save
Management on page 232).

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System Operation
System Startup
Power on the Panther System according to the instructions provided below.

Note—Every time the system is restarted, the internal modules must reach the
correct temperatures before the instrument can transition into the Ready or Assay
Processing states. This process may take up to 33 minutes.

System Startup
To start the Panther System:
1. Make sure that there are no Sample or Reagent Racks onboard the system and that
all doors, covers, and drawers are closed. Turn the Panther System on using the
power switch on the rear left of the instrument.
2. Open the Computer Door and use the power switch to turn on the computer.
l The Desktop Shield Utility starts and displays the Desktop Shield screen.

3. From the Desktop Shield screen, select Panther or wait 25 seconds for the Panther
System Software to automatically initiate.
l The Panther System Software starts and displays the Login screen.

l An initialization progress bar updates on the System Activity field as the system

proceeds through the start up process.

l The system unloads any MTUs left on the system with an estimated time to

completion listed at the bottom of the screen.

Login/Logoff
Log in and log off from the Panther System Software according to the instructions
provided below:

Login
To log in:
1. From the Login screen, select the User Name field and enter the user name using the
virtual keyboard.
2. Select OK or the Enter key.
3. Select the Password field and enter the password using the virtual keyboard.
Note—Passwords are not case sensitive, and must be between 6–15
characters.

4. Select OK or the Enter key.

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The Tasks screen opens.

If login is completed while the system is initializing or unloading MTUs, the activity field
on the Status Bar displays the system activity being performed and the time of completion.
All buttons on the Tasks screen are available once the system transitions to the Setup
state.

Logoff
To log off:
l Select the Logoff button on the Menu Bar. From the Logoff/Shutdown screen, select
Logoff.
The Login screen opens. System tasks already in process continue when logged off.

System Operation
Warning—Do not re-use Tips, MTUs, Waste Bags, or Waste Covers. Use
only tips, MTUs, and Waste Covers that are supplied by Hologic. Use of
unapproved consumables may compromise assay or Panther System
performance.

Use the Tasks screen to manage the instrument setup process. The Task Buttons have
been arranged on the Tasks screen to guide the operator in preparing the instrument to
begin assay processing. Use the Tasks screen to load fluids, empty waste, access
maintenance tasks, prime the instrument, and load reagents and samples.

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Figure 48. Tasks Screen (Example)

Load Tips
Pipette tips can be loaded at any time the system is not in the Initialization, Shutdown or
Error state. The operator does not need to be logged onto the system in order to load
pipette tips.
The two (2) Tip Drawers on the Panther can hold up to six (6) trays of 96 tips, for a total of
576 tips. The border of the Load Tips button and the Tip Count status bar changes to red
if there are no tips remaining. The Tip Count status bar changes to yellow if there are 96
tips (one tray) or fewer remaining.
Only one tip tray is ever in use by the instrument for each module unless the operator
chooses to replace tip trays in the drawer currently in use. The system removes all pipette
tips from a single drawer before proceeding to the next Tip Drawer. When a Tip Drawer
has been depleted, the system automatically unlocks that Tip Drawer. Once assay
processing begins, the Tip Count status bar will provide a return time for when more tips
will be needed to continue processing, if necessary.

To load tips:
1. Perform one of the following tasks to initiate the load tips process:

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l Open an unlocked Tip Drawer with a green LED drawer indicator.

l Select the Tips Count status bar at the bottom of the screen.
l Select the Load Tips button on the Tasks screen.
The Tip Loading Management window opens with a graphical display of both
drawers.

Figure 49. Tip Loading Management Window (Example)

Each tip tray icon will be outlined in one of the following three (3) colors indicating
the status of the tray.

Red—Tip tray is empty

Yellow—Tip tray is partially full

Green—Tip tray is full

2. Select the Unlock button for the desired Tip Drawer(s). The Tip Drawer(s) will have
automatically unlocked if all tips were depleted.
The selected drawer(s) will unlock and will be available for loading.

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Note—If the system is using pipette tips from the selected drawer, the
system will not unlock the Tips Drawer until the current process is complete.

3. Open the desired Tip Drawer(s).

The onscreen representation of the opened drawer will shift forward. All empty (red)
tray graphics will change to full (green) in expectation of the replacement of all empty
tip trays.

Note—In the Setup or Ready state, multiple drawers can be opened at the
same time.

4. Replace the empty tip trays in the open drawer according to the desired replacement
option detailed in the table below. Always load new tip trays carefully, making sure to
avoid contact with tip surfaces.
Table 53. Tip Replacement Options
Replacement Option Operator Instruction

Reload All 1. Remove empty tip trays.

Empty Trays 2. Load new tip trays.
(Default) 3. Close the Tip Drawer.

Reload All Partial 1. Remove empty and partial tip trays.

and Empty Trays 2. Load new tip trays.
3. Click the tray icon of the replaced partial tray in the Tip
Loading Management window until the border turns to
green.
4. Close the Tip Drawer.

Reload Only 1. Remove the selected tip tray(s).

Selected Trays 2. Load new tip trays.
3. Click the tray icon of the replaced tray(s) in the Tip
Loading Management window until the border turns to the
appropriate final status color.
4. Close the Tip Drawer.

5. The drawer(s) lock and the system updates the tip count. Ensure that all tip rack icons
on the screen have the appropriate colored borders, indicating successful
replacement, before proceeding.
6. Select Accept.
The window closes.

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Load MTUs
Multi-Tube Units (MTUs) can be loaded at any time the system is not in the Initialization,
Shutdown, or Error state. The operator does not need to be logged onto the system in
order to load MTUs.
The MTU Drawer can hold up to 25 MTUs, enough for 125 tests. The MTUs status bar in
the Status Panel displays the MTU inventory remaining based on the maximum number
of tests that can be run with the current inventory.
The border of the Load MTUs button and the MTUs status bar changes to red if there are
no MTUs in inventory. The MTUs status bar changes to yellow if the MTU inventory falls
below 10 tests. Once assay processing begins, the MTUs inventory panel will provide a
return time for when more MTUs will be needed to continue processing, if necessary.
To load MTUs:
1. Perform one of the following tasks to initiate the load MTUs process.
l Select the MTUs status bar at the bottom of the screen.

l Select the Load MTUs button on the Tasks screen.

l Pull out the MTU Drawer if the drawer is empty and the MTU Input Queue LED is

green.
An MTU Loading Management window opens and a status bar is displayed that
shows the progress of the MTU Input Queue moving to the load position. The MTU
Drawer is ready to be opened once the “MTU drawer unlocked” message is
displayed on the window and the LED indicator for the MTU Input Queue turns from
red to green.
2. When the drawer is ready to be opened, pull out the MTU Drawer.
Warning—Do not attempt to force the drawer open before prompted in
the MTU Loading Management window.

3. Load a box, or partial box, of MTUs onto the MTU Input Queue rail as follows:
Warning—Use the cardboard box to load MTUs. Avoid touching
individual MTUs or MTU Tiplets.

a. Remove the plastic shrink wrap from the MTU box and open the moveable flap.
b. Hold the box of MTUs by the sides, with the moveable flap at the top of the box
facing toward the instrument, and the MTU barcode facing to the right.
c. Slide the box down into the guides in the MTU drawer. Make sure that the MTUs
are securely in the guides.
If the entire box is not loaded, some MTUs will remain in the box. Do not
overload the MTU Drawer. These extra MTUs can be loaded later. Do not
remove unused MTUs from the box.
d. Smoothly slide the MTU box backward, away from the instrument.

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The MTUs on the guides remain in the drawer.

4. Visually inspect the MTUs:

l Check to be sure barcodes on the MTUs are present, properly aligned, and are

not damaged.
l Check that the distributor foot (handle) on each MTU is intact and undamaged.

The distributor foot is opposite the barcode.

l Check that the MTU Tiplets are in place. Do not replace dropped tiplets into

MTUs.
l Check for any extra MTU Tiplets inside the MTU tubes.

5. Remove any defective MTUs and discard.

6. Gently close the MTU Drawer.

Warning—Do not forcibly close or slam the MTU Drawer.

If the MTU Drawer does not close properly, check to make sure that the MTUs fit into
the drawer guide and that no more than 25 MTUs have been loaded.
After being closed, the drawer locks and the system updates the MTU count.

Load Universal Fluids

Load Panther Universal Fluids
The operator must manage the Panther Universal Fluids inventory under the following
conditions:

l The border of the Load Universal Fluids button is red from one (1) or both of the fluid
kits being depleted or invalid.
l The fluid kit inventory for A or B is below the number of fluid tests used during a

system prime. A Full Prime procedure consumes up to 105 tests per fluid kit.
The system monitors the remaining fluid inventory for all bottles in a fluid kit as a single
unit. The number of tests remaining for each kit can be found in the Fluid Kit status bars at
the bottom of the screen (A and B) and on the Universal Fluid Bay screen (see Universal
Fluid Bay Screen on page 58). The Panther can hold up to 2,000 tests of universal fluids
combined in the two (2) fluid kits.
Universal Fluids can be loaded at any time the instrument is in the Setup or Ready state.
The system is not able to enter the Ready operating state if the Universal Fluid inventory
is invalid.
Once a set of Panther universal fluids is loaded on the system, those bottles are depleted
as a kit, and must be changed together. The onboard stability for a fluid kit is 60 days. The
NaOCl Bottle is not kitted with Fluid Kit A or B. The NaOCl Bottle needs to be refilled with
5.0%–7.0% sodium hypochlorite (NaOCl solution) when replacing one (1) or both fluid
kits.

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Replace Panther Universal Fluids

To replace fluids:
1. Perform one of the following tasks:
l Select the Fluid Kit A or Fluid Kit B status bar at the bottom of the screen.

l Open the Panther Universal Fluids Drawer.

l Select the Load Universal Fluids button on the Tasks screen.

Warning—Do not open the Panther Universal Fluids drawer when

the instrument is in the Assay Processing state. Only open the
Panther Universal Fluids drawer when the instrument is in the
Setup or Ready state.

The Universal Fluid Bay window opens.

2. Check the remaining tests for each kit and determine if one or both kits need to be
replaced. Take into account the test count needed for system prime and sample
testing.
3. Disconnect the quick-connect fittings and remove the fluid bottles that need to be
replaced from the drawer.
4. If needed, remove any crystallization from the quick-connect fittings as follows:
a. Using DI water, dampen a wipe and wipe the connector on the tubing.
b. Remove the cap from the old bottle and rinse any crystallization off with a
squirt bottle containing fresh DI water. Ensure that the vent holes are clear of
any crystallization.
c. Cover the cap with a dry wipe, and tap it gently to remove water clinging to
the cap.
d. Rinse the quick-connect fitting and metal parts with DI water.

5. Remove the caps from the new bottles, and replace them with the caps
containing the quick-connect fittings.
6. Reseal the used fluid bottles with the caps from the new bottles and set aside.
7. Place the new bottles in the appropriate positions in the Universal Fluids Drawer.
8. Align RFID tags on bottles so that the white arrow above the tag is in line with the
arrow in the fluid drawer.
Each properly loaded fluid bottle will be represented by a green light on the
status panel in the Fluids Drawer. An invalid fluid bottle will generate a red light.
The LED light is off for an empty bottle position or an improperly aligned RFID
tag.

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Figure 50. Bottle Status Panel (Example)

9. Reconnect the fluid lines to the quick-connect fittings on the appropriate bottle
caps. Check the fluid line tags to confirm that the correct lines are connected to
the correct fluid bottles.
10. Discard the used fluid bottles according to laboratory policies.
11. Disconnect the NaOCl Bottle quick-connect fitting and remove the NaOCl Bottle.
Corrosive Warning—The NaOCl Bottle contains sodium
hypochlorite solution. Avoid contact with skin, eyes, and
mucous membranes. Wash affected area with water if contact
with this fluid occurs. Follow laboratory procedures for
working with sodium hypochlorite. Do not autoclave the
NaOCl Bottle.

12. Refill the NaOCl Bottle with 5.0%–7.0% sodium hypochlorite solution to between
the minimum and maximum fill lines.
13. Place the NaOCl Bottle in the appropriate position in the Fluids Drawer with the
handle pointing towards the center of the drawer.
14. Reconnect the fluid line to the NaOCl Bottle quick-connect fitting. Check the fluid
line tag to confirm that the correct line is connected to the NaOCl Bottle.
15. Verify that all fluids have been loaded properly by performing the following
checks:
l Check the Bottle Status Panel to verify that all LEDs are green.

l Ensure that all bottles are tightly capped and all 11 fluid connections have

been made.
16. Close the Fluids Drawer.
A Completing Universal Fluid Inventory window opens with a progress bar for
verification of the fluids inventory.
The Panther Universal Fluid Bay screen remains on display after completion of
this task.

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Empty Waste
Empty Waste—Warnings

Warning—Apply Universal Precautions when handling and

disposing of waste. Handle and dispose of solid and liquid
waste in accordance with laboratory policies.

Warning—Do not apply excessive force to the Waste Bag

while handling. If mishandling occurs, inspect the waste
bag for puncturing, remove any protruding tips while
following Universal Precautions, and place the entire bag
and contents into a new bag.

Warning—Treat the waste in the Liquid Waste Bottle as a

potential source of assay contamination. When handling
liquid waste, be careful not to contaminate the work
surfaces.

Warning—Clean spilled waste immediately by wiping the

surface with a 2.5%–3.5% sodium hypochlorite solution.
Let the sodium hypochlorite solution sit for one (1) minute,
and then wipe with DI water.

Warning—Do not reuse Waste Bags and Waste Covers.

Use only Waste Bags and Waste Covers supplied by
Hologic. Use of unapproved Waste Bags and Waste
Covers can interfere with assay or system performance.

Corrosive Warning—The Liquid Waste Bottle contains

sodium hypochlorite solution. Avoid contact with skin,
eyes, and mucous membranes. Wash affected area with
water if contact with this fluid occurs. Follow laboratory
procedures for working with sodium hypochlorite solution.
Do not autoclave the Liquid Waste Bottle.

Emptying Panther Waste

The operator must manage the waste inventory under the following conditions:
l The border of the Empty Waste button is red from a depleted remaining waste
inventory.
l The border of the Empty Waste button is flashing yellow and waste inventory is
below the configurable waste threshold.
l The remaining waste inventory is below the waste capacity consumed during a
system prime. A Full Prime procedure consumes 50 tests of waste capacity.

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The waste can be emptied at any time the instrument is in the Setup or Ready state.
The operator must manage the waste containers any time the number of tests to be
run exceeds the remaining capacity level. Both waste containers must be replaced
together.
The system tracks the remaining capacity of the two (2) waste containers in the
Waste Drawer and displays the waste space available in number of tests remaining.
This information is available in the Waste status bar at the bottom of the screen and
on the Waste Management screen.
The Panther has waste capacity of up to 750 tests. All liquid waste is drawn into the
Liquid Waste Container and all solid waste is deposited in the Solid Waste
Container.
A configurable waste threshold can be set at a level less than the system waste
capacity in order to inform the operator that the waste containers are nearly full (see
Threshold Management on page 220). Samples can be loaded that would surpass
this threshold, but the System will warn the operator that the threshold has been
exceeded and the Waste consumable status icon will begin to flash yellow once the
limit has been exceeded. When the remaining Waste test count reaches zero, the
system will discontinue pipetting loaded samples.

To empty the waste:

1. Perform one of the following tasks:
l Select the Waste status bar at the bottom of the screen.

l Select the Empty Waste button on the Tasks screen (see Tasks Screen on

page 56) under the Panther column.

The Panther Waste Management screen opens.
2. Check the tests remaining in the waste inventory and determine if it needs to be
replaced. Take into account the test count needed for system prime and sample
testing.
3. If it is necessary to empty the waste containers, select the Unlock Waste Bay
button.
The Waste Drawer unlocks and the vacuum turns off.
4. Slide the Waste Drawer completely open, remove the Liquid Waste Container
from the drawer, and transfer it to the disposal location.
5. Remove the bottle cap from the Liquid Waste Container.
6. Slowly pour the contents of the Liquid Waste Container into the designated sink
or receptacle.
Warning—Tilt the Liquid Waste Container appropriately to ensure that no
waste enters the tubing within the container. Use the numerous holds on
the container to aide in pouring of the contents.

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Figure 51. Disposing of Liquid Waste Container Contents (Example)

7. Replace the cap on the Liquid Waste Container.
8. Return the Liquid Waste Container to its position in the Waste Drawer and press
down firmly to connect the fittings to ensure a sealed connection.
9. Carefully lift the Waste Cover off the Solid Waste Container, handling it only by
the sides. Place the Waste Cover inside the Waste Bag.
10. Remove and dispose the Waste Bag according to laboratory policies.
11. Fit a new Waste Bag into the Solid Waste Container taking care to perform the
following tasks:
l Press the bag down into the Solid Waste Container, smoothing the sides of

the bag flat to the sides of the container.

l Fold the top of the bag down around the outside of the Solid Waste

Container.
12. Slide a new Waste Cover over the Waste Bag on the back of the container.
13. Perform the following checks to finalize the empty waste procedure.
l Ensure that the Waste Cover is mounted properly on the back of the Solid
Waste Container.
l Ensure that the Liquid Waste Container is tightly capped and secure in the
drawer.
14. Close the Waste Drawer.
The drawer locks and the vacuum turns on. A progress bar remains onscreen
until the system can complete verification of the waste inventory and vacuum
pressure.

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The Panther Waste Management screen remains on display after completion of this
task.

Perform Maintenance
Complete all required maintenance tasks before the required time to transition into the
Ready state. Maintenance tasks can be performed any time the instrument is in the Setup
or Ready state. Select the Perform Maintenance button on the Tasks screen to view the
maintenance schedule on the Maintenance Activities screen. The table on the screen
provides times when maintenance activities are due and when automated maintenance
tasks are set to proceed.

Figure 52. Maintenance Activities Screen (Example)

It is not possible to process samples once a required task becomes past due. Refer to the
General Maintenance Information section for guidance on completing Panther System
maintenance tasks (see General Maintenance Information on page 189).

Prime Instrument
The fluid lines must be primed to eliminate bubbles under the following conditions:
l After changing a Panther Universal Fluid kit
l 7.5 hours have elapsed since the last prime

l 7.5 hours have elapsed since the system pipetted the last loaded test order

A red border on the Prime Instrument button on the Tasks screen indicates that priming
is needed.

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The system tracks the time that the system prime remains valid. The Prime panel on the
Panther Universal Fluid Bay screen lists the amount of time remaining before the system
must be primed again.
The system is designed to run two (2) prime procedures: Full Prime and Mini-Prime. The
system automatically chooses the appropriate prime procedure once priming is initiated,
although it is possible to perform a Full Prime according to the Force Full Prime section
(see Force Full Prime on page 106).
A Full Prime will be performed under the following circumstances:
l If the system has been powered down since the last prime or run
l More than 26 hours have elapsed since the last prime or test result

l A Panther Universal Fluid set has been changed

l The Mini-Prime was invalid

The following table lists the resource consumption for a Full Prime and a Mini-Prime.
Table 54. System Prime Resource Consumption
Full Prime Mini-Prime

Time to Complete 12 Minutes 10 Minutes

50 Tests 15 Tests
MTUs Count Consumed
35 Tests* 10 Tests*

Waste Test Count

50 Tests 15 Tests
Consumed

Maximum Fluid Test Count 8 Tests

105 Tests
Consumed Per Kit 0 Tests*

*Indicates amount of tests if system is configured to real-time only mode.

Prime Criteria
The following conditions must be met in order to initiate a system prime:
l The system is in the Setup or Ready state.
l The MTUs count is adequate.

l The Panther fluid inventory for both Kit A and Kit B is valid and adequate.

l The waste capacity is adequate.

Before initiating the procedure, the operator needs to ensure adequate fluid and
waste inventory for assay processing following prime. Make the necessary
calculations to ensure that there will be enough fluid and waste inventory remaining

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after priming to account for the 5 tests consumed for the lead MTUs and for all test
orders.

Prime Procedure
To prime the instrument:
1. Ensure that all resources necessary for a Full Prime are currently available.
2. Ensure that the Waste and Panther Universal Fluid Kit inventories are sufficient
for assay processing following prime.
3. Perform one of the following tasks:
l From the Tasks screen, select Prime Instrument.

l Configure the system to automatically perform a prime at a specified time

(see Priming Management on page 222).

When priming, the State Indicator bar displays Priming Instrument. A system
update appears in the activity field in the Status Panel indicating the completion
time for the priming procedure. Task buttons for the tasks that cannot be
completed in this state are unavailable on the Tasks screen.
After a successful prime the Prime panel on the Panther Universal Fluid Bay
screen updates to show the time remaining until another prime will be needed.

Force Full Prime

To force a Full Prime:
1. Ensure that all resources necessary for a Full Prime are available.
2. From the Tasks screen, select Perform Maintenance.
The Maintenance Activities screen opens.
3. From the Maintenance Activities screen, select Force Full Prime.
The system performs a Full Prime.

Load Panther Assay Reagents

See the appropriate assay package insert for reagent preparation instructions and
stability information.

Master Lot information can be added and assay reagent kits can be loaded onto the
system when the system is in the Setup, Priming Instrument, Ready, and Assay
Processing states and a Panther Reagent Bay Lane is available for loading. Specimens
associated with a reagent kit must be pipetted before the assay reagent kit expiration
time.

Master Lot Setup

Register the assay reagent master lot information before loading an assay reagent

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kit. The master lot barcode can be found on the Master Lot Barcode Sheet that is
included with each assay reagent kit. Register the master lot barcode to ensure that
only the reagents belonging to a specific master lot can be run together on the
system.
Each master lot barcode only needs to be entered once into the system. Inactivate
master lots as needed to prevent the system from recognizing the assay reagent kit.
Inactivated master lot information remains in the database, but cannot be used to run
assays.

Add a New Master Lot

To add a new Master Lot to the database:

1. Select the Load Assay Reagents icon on the Tasks screen.
The Panther Assay Reagent Bay screen opens.
2. At the bottom of the Panther Assay Reagent Bay screen, select
New/Activate Lot.
A New/Activate Master Lot window opens.

Figure 53. New/Activate Master Log Screen (Example)

3. Using the handheld barcode scanner, scan the Master Lot barcode on the
Master Lot Barcode Sheet.
The Lot Number of the new Master Lot populates the Master Lot Barcode
text box in the New/Activate Master Lot window. The New/Activate Master
Lot window expands if the Master Lot Barcode is new to the system.
4. Scan the barcodes on the Master Lot Barcode Sheet for each component
belonging to the Master Lot. The barcodes can be scanned in any order.
As each barcode is scanned, the barcode populates the appropriate text
box in the New/Activate Master Lot window.
5. Select Accept.

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The new Master Lot and its component barcodes are registered in the
database. The New/Activate Master Lot window closes and the operator is
returned to the Panther Assay Reagent Bay screen.

Inactivate a Master Lot

To inactivate a Master Lot:

1. Select the Load Assay Reagents icon on the Tasks screen.
The Panther Assay Reagent Bay screen opens.
2. At the bottom of the Panther Assay Reagent Bay screen, select Inactivate
Lot.
An Inactivate Master Lot window opens.

Figure 54. Inactivate Master Lot Window (Example)

3. Scan the Master Lot barcode on the Master Lot Barcode Sheet to enter it into
the Master Lot Barcode field.
The Lot Number of the Master Lot to be inactivated populates the Master
Lot Barcode field.
4. Select Accept.
If the barcode is valid and exists in the database, it is inactivated. The
Inactivate Master Lot window closes and the operator is returned to the
Panther Assay Reagent Bay screen.

Reactivate a Master Lot

To reactivate a Master Lot:

1. Select the Load Assay Reagents icon on the Tasks screen.
The Panther Assay Reagent Bay screen opens.
2. At the bottom of the Panther Assay Reagent Bay screen, select
New/Activate Lot.
A New/Activate Master Lot screen opens.

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3. Using the handheld barcode scanner, scan the Master Lot barcode from the
Master Lot Barcode Sheet.
If the Master Lot information had previously been inactivated, the
New/Activate Master Lot window expands with all lot information fields
populated.
4. Select Accept.
The reactivated Master Lot is once again available to be used for assay
processing. The New/Activate Master Lot Barcode window closes and the
operator is returned to the Panther Assay Reagent Bay screen.

Reagent Kit Date Extension

Extend the expiration date for an assay reagent Master Lot when directed by
Hologic. Detailed instructions for how to extend the Master Lot expiration date
will be provided by Hologic. The date extension procedure is performed through
the Panther Assay Reagent Bay screen using the Date Extend Lot button
located on the New/Activate Master Lot Barcode window.

Loading Panther Assay Reagents into Racks

1. Ensure that the reagent bottles are labeled with the date and initials to identify
bottles belonging to a kit.

Figure 55. Panther Reagent Rack (Example)

2. Mix each reagent bottle thoroughly by gentle inversion prior to loading in the rack.
Avoid creating foam.
3. Remove and discard the caps from the assay reagent bottles and visually inspect
each reagent for foam, bubbles, and undissolved particles.

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Caution—Inspect Assay Reagents for foam, bubbles, and undissolved

particles before loading them on the Panther System. Do not use
reagents with foam, bubbles, or undissolved particles in the Panther
System.

4. Slide the bottles into the correct position in an appropriately sized Reagent Rack.
5. Verify that the barcode for each bottle is visible through the slot in the rack.

Loading Panther Assay Reagents

Caution—Do not use assay reagent kits on multiple Panther Systems.

Onboard stability tracking will be inaccurate and may lead to assay failure.

The system groups a set of assay reagents the first time that they are loaded. They
are then required to be run as a "matched kit" in all subsequent worklists. Bottles
belonging to a matched kit cannot be swapped with bottles in other sets of assay
reagents. Use the Assay Reagent Report to identify bottle IDs belonging to a
matched set (see Assay Reagent Report on page 166).

Caution—Spilling the contents of assay reagent bottles before loading may

lead to assay failure. The Panther System updates the remaining tests
available in an assay reagent kit following a spill before pipetting the reagent.
A loss of volume in the Amplification, Enzyme, Probe, and Selection Reagents
may impact the ability of the system to complete assay processing.

To load Panther Assay Reagents:

1. Open the Reagent Bay Door.
The Panther Assay Reagent Bay screen opens.
2. Lift the rack by the handle in the back, supporting the rack with the other
hand.
3. Before loading the rack into a Reagent Bay Lane, ensure that the onscreen
Reagent Bay Lane graphic is bordered in purple and the Reagent Bay Lane
LED is flashing green.
4. After the conditions in Step 3 have been met, gently slide the Reagent Rack
into the appropriate lane in the Reagent Bay until it reaches the back of the
bay.
The Reagent Barcode Reader will automatically scan the Reagent Rack
and assay reagent barcodes as the rack is loaded.
If the Reagent Rack was successfully loaded onto the system, the TCR
Carousel stops spinning and position 1 is rotated to the front of the
instrument. This process may be delayed if reagents are currently being
pipetted. Once the TCR Carousel stops the TCR Door unlocks.

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5. Load up to four (4) Reagent Racks as necessary, following steps 2–4. Close
the Reagent Bay Door after all Reagent Racks have been loaded.
6. Open the TCR Door.
7. Load the corresponding Target Capture Reagent (TCR) and Target
Enhancer Reagent (TER), if necessary, into the TCR Carousel. If multiple
Reagent Racks were loaded, multiple TCR and TER bottles must be loaded
as appropriate.
To load TCR and TER:
a. Mix the TCR and TER bottles thoroughly by gentle inversion prior to
loading on the carousel. Avoid creating foam.
b. Visually inspect the reagents for foam, bubbles, and undissolved
particles.
c. Ensure the appropriate size TCR Adapter is loaded into the needed
TCR Carousel position.
d. Slide the TCR bottle into the TCR cup that matches the Reagent Bay
Lane number of the corresponding assay reagent kit. Press down firmly
on the TCR bottle to ensure that the bottle is fully inserted in the cup.
e. If needed, slide the TER bottle into the TER cup that matches the
Reagent Bay Lane number of the corresponding assay reagent kit.
Press down firmly on the TER bottle to ensure that the bottle is fully
inserted in the cup.
f. Verify that the barcodes of the TCR and TER bottles are visible through
the slots in the cups. If necessary, rotate the TCR Carousel to ensure
the proper placement of the bottles.
8. Load up to four (4) bottles of TCR and TER to correspond to the racks
loaded in the Reagent Bay, following step 7.
9. Close the TCR Door once all TCR and TER bottles have been loaded.
The TCR Carousel starts to rotate and the system scans all TCR Carousel
positions. TCR or TER pipetting will resume if a run was previously in
progress. The Supplemental Reagent Information window opens for the
operator to enter the reconstitution dates and TCR additive for each new kit
that was loaded, as necessary.

Figure 56. Supplemental Reagent Information Window (Example)

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Note—Scan the Master Lot barcode with the handheld scanner

when loading assay reagent kits that include reagent lots used
across multiple Master Lots. An additional field for the Master Lot
barcode is provided under this loading scenario.

Figure 57. Supplemental Reagent Information Window—Redundant Lots

(Example)
10. Enter the assay reagent kit information as follows:
a. Enter the date that the assay reagent kit was prepared.
b. If the assay reagent kit requires the addition of a TCR additive, select
the TCR Additive field and use the handheld barcode scanner to enter
the barcode of the additive.
c. Repeat steps a and b for all assay reagent kits loaded onto the system,
as needed.
d. Select Accept when finished entering the assay reagent kit information.
The system groups the kit into a matched set. The system updates the
Panther Assay Reagent Bay screen to show the assay type, the number of
available tests, and the remaining onboard stability time for each loaded kit.

Note—If loading multiple assay reagent kits of the same assay type,
the system automatically deducts tests from the assay reagent kit
that was loaded onto the system first.

Unloading Panther Assay Reagents

Assay reagent kits can be unloaded from the system whenever the kit is not currently
involved in assay processing. Removing reagents that are not in use preserves
assay reagent onboard stability. The assay reagent kit-associated control or
calibrator status is invalidated when the assay reagent kit is removed from the
system. Assay reagent kits must be unloaded before the system is shut down.

Warning—Do not remove Reagent or Sample Racks that are currently in

use by the system. Do not remove racks when the lane LED is red and
the rack graphic on the screen is yellow with a red border.

To unload Assay Reagents:

1. Open the Reagent Bay Door.

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The Panther Assay Reagent Bay screen opens.

2. From the Panther Assay Reagent Bay screen, ensure that the rack icon(s) of the
assay reagent kit(s) to be removed are not yellow.
3. Ensure that the Reagent Bay Lane LED(s) of the assay reagent kit(s) to be
removed are not red.
4. Gently slide the Reagent Rack out of the Reagent Bay Lane. Multiple racks can
be unloaded simultaneously assuming conditions from steps 2 and 3 are met.
The Reagent Bay Lane graphic on the screen changes to gray.
If the Reagent Rack was successfully unloaded, the TCR Carousel stops
spinning and position 1 will be rotated to the front of the instrument. This process
may be delayed if the TCR or TER of another assay reagent kit is currently in
use. Once the TCR Carousel stops spinning, the TCR Door unlocks.
5. Unload all racks as necessary, following steps 2–4. Close the Reagent Bay Door
once all desired racks have been removed.
6. Open the TCR door.
7. Unload the TCR and TER bottles that correspond to the racks removed from the
Reagent Bay, from the TCR Carousel. If multiple Reagent Racks were unloaded,
all corresponding TCR and TER bottles must be unloaded.
8. Close the TCR Door.
The TCR Carousel rotates and scans all TCR Carousel positions. If any
reagents in the TCR Carousel onboard are currently in use, pipetting will
resume.

Load Samples
Load properly prepared controls, calibrators and specimens into the Panther Sample
Racks for sample identification and processing. Sample Racks can be loaded onto the
system when the system is in the Setup, Prime, Ready and Assay Processing states.

Adding a New Control/Calibrator Lot

Note—This feature is not available for all system software configurations.

To add a new lot of controls or calibrators for quantitative assays:

1. Select the Load Samples icon on the Tasks screen.
The Sample Rack Bay screen opens.
2. At the bottom of the Sample Rack Bay screen, select New Ctrl/Cal Lot.
A Control/Calibrator Lot Entry window opens.

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Figure 58. Control/Calibrator Lot Entry Screen (Example)

3. Using the handheld barcode scanner, scan the top barcode on the Calibrator or
Control Lot Barcode Sheet.
4. Scan all of the barcodes on the Calibrator or Control Lot Barcode Sheet for the
new lot. The barcodes can be scanned in any order.
5. Select Accept when finished.
The new control or calibrator lots are registered in the database. The
Control/Calibrator Lot Entry window closes and the operator is returned to the
Sample Rack Bay screen.

Figure 59. Sample Rack Bay Screen (Example)

6. Repeat these instructions if loading more than one lot of calibrators or controls.

Controls/Calibrators Setup
Refer to the appropriate assay package insert regarding requirements for control
and/or calibrator validity. Controls/calibrators can be loaded in any position in
the sample rack and the rack can be loaded in any lane of the Sample Bay.
Specimens will be pipetted when one of the following two (2) conditions have
been met:

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l A set of controls/calibrators is currently being processed by the system.

l Valid results for the control/calibrator set are registered on the system.

Specimens associated with a set of controls/calibrators must be pipetted before

the control/calibrator expiration time displayed on the Run Status screen. The
following limitations apply:
l Control/calibrator set results are invalid.
l After Run New Ctrls/Cals has been selected (see Run New

Controls/Calibrators on page 115).

l The associated Panther assay reagent kit is removed from the system. A

new set of controls/calibrators is required when a reagent kit is removed and

then reloaded on the system.
l The associated assay reagent kit lot has exceeded its stability limits.

Specimens associated with the set of controls/calibrators must be pipetted

before the controls/calibrators expiration time or they will not be processed.
Each control/calibrator tube can only be tested once.

Control/Calibrator Processing
The system will only pipette controls or calibrators on an as-needed basis. Once
loaded, controls and calibrators will have a “C” on the representative tube
location on the Sample Rack Bay or Run Status screen. The number of the
reagent lanes assigned to the control/calibrator is shown next to the assay type
within the Assays column on the Sample Rack Bay screen.
The system will automatically pipette a new set of controls/calibrators if:
l The last control/calibrator set results are invalid for the associated loaded kit.
l The last control/calibrator set results are expired for the associated loaded
assay reagent kit.
l Run New Ctrls/Cals has been selected (see Run New Controls/Calibrators
on page 115).

Run New Controls/Calibrators

Require a new set of controls/calibrators for processing new specimens through
the Panther Assay Reagent Bay screen. This functionality can only be used if
the current status of the control/calibrator set is valid (refer to the Panther
Reagents panel on the Run Status screen for the control/calibrator status). Once
a new set of controls/calibrators is required for a loaded assay reagent kit, a new
set of controls/calibrators will need to be loaded before specimens can be tested
with the assay reagent kit.
To require a new set of controls/calibrators:
1. From the Panther Assay Reagent Bay screen, select Run New Ctrls/Cals.
The Run New Ctrls/Cals window opens.

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2. Select the lane of the assay reagent kit associated with the control/calibrator
set to be invalidated.
3. Select OK.

Loading Samples into Sample Racks

Refer to the appropriate assay package insert for information concerning the preparation
of samples for processing, for recommended sample storage conditions, and for sample
handling. Load controls, calibrators, and specimens into Sample Racks before loading
the racks onto the system. Up to 15 samples can be loaded into a Sample Rack. Controls,
calibrators, and specimens can be loaded in any order and any position in the Sample
Rack.

Note—Make sure that the samples meet the appropriate sample volume
requirements before loading them into sample racks.

Note—Improperly prepared samples may cause errors on the system.

Refer to the appropriate assay package insert for important sample
preparation instructions.

Caution—Avoid touching the tops of specimens, controls, and

calibrators during preparation and loading.

Caution—Use only the sample racks and sample tubes that are
designed for use on the system.

Caution—Always handle specimens, controls, and calibrators cautiously

and keep sample racks upright to prevent splashing or spilling.

Caution—Ensure that all specimens, controls, and calibrators are

loaded straight and seated firmly in the sample rack.

Caution—Prior to loading, inspect all specimens, controls, and

calibrators for undissolved particles, clots, foam, or bubbles. Do not
attempt to use samples with undissolved particles, clots, foam, or
bubbles on the system.

To load samples into Sample Racks:

1. Obtain a clean Sample Rack and position the rack in the Rack Loading Tray on a
clean work surface.

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Figure 60. Panther Sample Rack—With Retainer

2. Without touching the tops of the tubes, gently slide the control, calibrator, or
specimen tubes into the slots in the Sample Rack.
3. Make sure that all tube barcodes are visible through the slots and are firmly
seated in the rack.
4. When finished loading tubes in the Sample Racks, carefully place clean Sample
Retainers on the Sample Racks that require it. Refer to the appropriate assay
package insert for additional sample tube loading information. The Sample
Retainers need to be properly seated to enable loading onto the system.
Note—Systems that do not run assays which utilize pierceable caps do
not require the use of a Sample Retainer unless the system is
configured to Require Retainers for Sample Racks (see Require
Retainers for Sample Racks on page 225).

5. Repeat Steps 1–4 for all Sample Racks.

Sample Defaults
During batch loading, specimens are automatically assigned test orders upon loading via
Sample Default settings. All specimens loaded are assigned test orders according to the
Sample Default settings.
Configure the testing criteria through the Sample Defaults panel on the Sample Rack Bay
screen. Set sample testing default information prior to loading samples. Sample Defaults
can be edited when the system is in the Setup, Priming Instrument, Ready, and Assay
Processing states.

Adding an Assay to the Sample Defaults

To add an assay test to the Sample Defaults:

1. From the Sample Defaults panel of the Sample Rack Bay screen, select Set.

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The Sample Defaults window opens with current default assay types and test
replicate settings.

Figure 61. Sample Defaults Window (Example)

2. From the Sample Defaults window, select Add.
A Select Default Assays window opens with a display of all available assays.
3. Select the desired assay(s) to add assay test orders to the sample defaults.
Select more than one assay type if needed.
4. If an assay has multiple analytes, select the analytes to be tested, if necessary, by
selecting Select Analytes. If not changing the analyte selection, skip to step 7.
An Analyte Selection window opens.
Note—Use the Select Analytes functionality to select a single analyte
test order from assays with multiple targets, if necessary. Remove the
total RLU for the analyte that is not selected (suppressed) by enabling
the Enable RLU value suppression for Aptima Combo 2
configuration (see Results Management on page 227).

5. Add or delete analytes as appropriate by selecting Add or X for the analytes

available on the screen.
6. Select OK to accept the chosen analytes.
The Analyte Selection window closes.
7. Select OK to accept the chosen test order configuration.
The Select Default Assays window closes. The Sample Defaults window
remains on display after completion of this task.
8. To continue with sample default setup, select another button on the window or
select Accept to accept all changes and exit to the Sample Rack Bay screen.

Altering Replicate Count for Sample Defaults

To alter the number of replicates tested for each of the selected default assays:
1. From the Sample Defaults panel of the Sample Rack Bay screen, select Set.

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The Sample Defaults window opens with current default assay types and test
replicate settings.
2. From the Sample Defaults window, select the Replicates field.
A number keypad opens.
3. From the keypad, choose the desired number of replicates to be tested for all
chosen assay types in the sample defaults and select OK when finished.
The number keypad closes. The Replicates field updates with the desired
replicate number.
The Sample Defaults window remains on display after completion of this task.
4. To continue with sample default setup, select another button on the window or
select Accept to accept all changes and exit to the Sample Rack Bay screen.

Deleting an Assay Test from the Sample Defaults

To delete an assay test from the Sample Defaults:

1. From the Sample Defaults panel of the Sample Rack Bay screen, select Set.
The Sample Defaults window opens with the current default assay types and
test replicate settings.
2. From the Sample Defaults window, select the X button next to the assay(s) to be
removed from the sample defaults.
The selected assay test(s) are removed from the Sample Defaults window.
The Sample Defaults window remains on display after completion of this task.
3. To continue with sample default setup, select another button on the window or
select Accept to accept all changes and exit to the Sample Rack Bay screen.

Configuring Additional Sample Defaults

To alter additional Sample Defaults options:

1. From the Sample Defaults panel of the Sample Rack Bay screen, select Set.
The Sample Defaults window opens with current default assay types and test
replicate settings.
2. From the Sample Defaults window, select More.
The Sample Defaults screen expands with a display of sample prefix and suffix
information fields.

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Figure 62. Expanded Sample Defaults Window (Example)

3. Select one of the following fields to amend as desired:
Table 55. Additional Sample Default Options
Option Description

Non-Barcode This prefix will be added before the index number for
Sample Loading samples added when the Enable Non-Barcode Sample
Prefix Loading configuration is enabled (see Specimen Loading
on page 224).

Non-Barcode The number entered will become the SID for the first sample
Sample ID when the Enable Non-Barcode Sample Loading
starting number configuration is enabled. Each additional sample loaded is
labeled sequentially (see Specimen Loading on page 224).
Select Restart Next Rack to return the starting number to 1.

Note—Resetting the Non Barcode Loading Starting number

while loading samples in the same worklist can create
repeat Sample IDs within the worklist and lead to two (2) or
more specimens with the same Sample ID.

Worklist ID The entered alpha-numeric sequence will become the suffix

Suffix added to the Worklist ID for samples loaded when the
Enable Worklist ID Suffix configuration is enabled (see
Specimen Loading on page 224). After processing, these
samples will be organized under the entered ID suffix in
results reports. Select Clear Suffix to remove the content of
the cells.

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A virtual keyboard opens after selecting the chosen field.

4. Erase the current content or adjust the fields with the virtual keyboard and select
OK to accept.
The virtual keyboard closes and the field adjusts accordingly.
5. To continue with sample default setup, select another button on the window or
select Accept to accept all changes and exit to the Sample Rack Bay screen.

Manually Download Test Orders

During Random Access sample loading, with systems connected to an LIS, the
system can either retrieve test orders through automatic host query, or via manual
download (see Specimen Processing Modes on page 214). If not configured for
automatic host query, manually download the test orders before loading the
specimens into the system. This allows the test orders to be matched with the
specimens upon loading.
To manually download test orders from an LIS:
1. From the Test Orders screen, select Fetch from LIS.

Loading Sample Racks

Load Sample Racks into the Sample Bay

Up to eight (8) Sample Racks can be loaded onto the system at a time. Ensure that
all drawers and doors other than the Sample Bay Door are closed when loading
Sample Racks.
To load Sample Racks:
1. Open the Sample Bay Door.
The Sample Rack Bay screen opens.
2. Lift a Sample Rack by the handle in the back from the Rack Loading Tray, if used,
and transport the rack to the system.
3. Before loading the rack into a Sample Bay Lane, ensure that the onscreen
Sample Bay Lane graphic is bordered in purple and the Sample Bay lane LED is
flashing green.
4. After the conditions in Step 3 have been met, gently slide the Sample Rack into
the appropriate Sample Bay Lane until it reaches the back of the bay.
Note—The operator can choose an alternate empty Sample Bay Lane
other than the default choice by clicking on the desired lane on the
Sample Rack Bay screen and then selecting Change Scan Lane.

The Sample Barcode Reader will automatically scan the Sample Rack and
sample barcodes as the rack is loaded. Samples are registered by the system

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starting with Tube Position 1 (position farthest from the handle) to the last
position loaded in the rack. Sample IDs are assigned to the loaded samples
according to the current sample loading mode (see Specimen Processing
Modes on page 214).
The Sample Bay Lane LED of the lane being loaded flashes green during the
scanning process. The LED light stops flashing and remains green if the Sample
Rack is valid.
5. Load up to eight (8) Sample Racks (maximum of 120 samples) as necessary
following Steps 2–4. Load additional Sample Racks, one at a time, after meeting
all conditions listed in Step 3.
6. Close the Sample Bay Door after all racks have been loaded.
If all of the criteria to initiate sample pipetting have been met, the system will
automatically start pipetting the samples based upon the order that the racks
were loaded (see Initiating Assay Processing on page 130).

Note—The system will not start pipetting samples with associated

Pending items until all Pending items have been addressed.

Assigning a Reagent Lane for Aptima Assays

Use the Assign Reagent Lane functionality through the Sample Rack Bay screen to
select the assay reagent kit that is to be used to process all specimens in the
designated Sample Rack.
To assign a reagent lane:
1. Ensure that the Sample Defaults have been selected as desired for the next
Sample Rack to be loaded according to the instructions in the Sample Defaults
section (see Sample Defaults on page 117).
2. From the Sample Rack Bay screen, select the Assign Reagent Lane button.
The Select Reagent Lanes window opens.

Figure 63. Select Reagent Lanes Window (Example)

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3. Select the number of the lane (1–4) with the assay reagent kit to be used to
process the specimens in the next loaded Sample Rack.
4. Select Accept.
The Select Reagent Lanes window closes and the Sample Defaults panel
updates to display the chosen lane number.
5. Load the Sample Rack to be tested with the Reagent Lane displayed in the
Sample Defaults panel according to the instructions in the Loading Sample
Racks into the Sample Bay section (see Load Sample Racks into the Sample
Bay on page 121).
6. Close the Sample Bay door.
All specimens in the Sample Rack will be processed with the designated assay
reagent kit. The number of the chosen Reagent Lane will be displayed in the
Lane panel of the Sample Rack Bay screen.
7. Repeat Steps 1–6 for each additional Sample Rack.

Editing Specimen Test Orders

Test orders can be added or deleted from a sample after the sample has been
loaded onto the system. Test orders can be edited after the sample has been loaded
and when the system is in the Setup, Priming Instrument, Ready, and Assay
Processing states.

Adding a Test Order

Add test orders for loaded specimens through the Sample Details screen (see
Sample Details Screen on page 68 and see Sample Rack Loading Screen on
page 66).
To add a test order:
1. From the Sample Rack Bay screen, double-click the loaded rack that
includes the specimen(s) of interest or select the onscreen image of the
desired Sample Rack and select Rack Details.
The Sample Rack Loading screen opens for the selected Sample Rack. To
add test orders to the entire Sample Rack, select Add Test Orders All and
proceed to Step 4.
2. From the Sample Rack Loading screen, click the specimen of interest or
select the Sample Details/Edit button and select the specimen of interest.
The Sample Details screen opens with the current test orders for the
selected specimen tube.
3. Select Add Test Order at the bottom of the screen.
The Add Test Orders window opens.

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Figure 64. Add Test Orders Window (Example)

4. Select Add.
The Test Order Assays window opens with a display of assays that are
available for the chosen specimen type.
5. Select the desired assay row(s) to add test orders to the selected specimen.
6. If selecting an assay with multiple analytes, select the analytes to be tested,
if necessary, by selecting Select Analytes. If not changing the analyte
selection, skip to Step 9.
Note—Use the Select Analytes functionality to select only a single
analyte test order from assays with multiple targets, if necessary.
Remove the total RLU for the analyte that is not selected
(suppressed) by enabling the Enable RLU value suppression for
Aptima Combo 2 configuration (see Results Management on page
227).

7. Add or delete analytes as appropriate by selecting Add or X for the analytes

available on the screen.
8. Select OK to save the analyte setting and return to the Test Order Assays
window.
9. Select OK on the Test Order Assays window when finished selecting the test
order assay type(s).
10. Select the Replicates field to choose the desired number of replicates for the
additional test order.
A number keypad opens.
11. Type in the desired number of replicates to be tested with the chosen assay
type and select OK when finished.
The Replicates field updates with the desired replicate number.
12. Select Accept to accept the chosen test order(s) and replicate count.

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Note—If test orders were added to the entire rack, an Add Tests for
Rack window appears to confirm tests will be added for all
specimens in the Rack. Select Yes to continue.

The Add Test Orders window closes.

13. Repeat Steps 2–12 to add test orders for any additional specimens in the
selected Sample Rack.

Deleting a Test Order

Delete test orders through one of the following two (2) screens:
l Sample Details screen (see Sample Details Screen on page 68)
l Test Orders screen (see Test Orders Screen on page 72)

To delete a test order through the Sample Details screen:

1. From the Sample Rack Bay screen, click the loaded rack with the specimen
(s) of interest or select the onscreen image of the desired Sample Rack and
select Rack Details.
The Sample Rack Loading screen opens for the selected Sample Rack.
2. From the Sample Rack Loading screen, click the specimen of interest or
select the Sample Details/Edit button and select the specimen of interest.
The Sample Details screen opens with the current test orders for the
selected specimen.
3. Select the test order to be deleted from the Test Orders panel.
4. Select Delete Test Order.
A confirmation window opens.
5. Select OK to confirm the deletion.
The test order is deleted.
6. Repeat Steps 2–5 to delete test orders for any additional specimen tube in
the selected Sample Rack.
To delete a test order through the Test Orders screen:
1. From the Test Orders screen, select the test order(s) to be deleted.
2. Select Delete.
A confirmation window opens.
3. Select OK to confirm the deletion.
The test order is deleted.
To delete a test order through the Sample Rack Loading screen:
1. From the Sample Rack Loading screen, select Remove All Test Orders.

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A confirmation window opens.

2. Select Yes to confirm the deletion.
All test orders are deleted.

Scheduling STAT Test Orders

Add the STAT priority to a test order for a loaded specimen through the Sample
Details screen (see Sample Details Screen on page 68). Adding the STAT
designation to a test order prioritizes the test order to be run in the next available
MTU time slot. The option to set STAT for an entire sample rack is also
available.
To add the STAT designation to a test order:
1. From the Sample Rack Bay screen, click the loaded rack with the specimen
(s) of interest or select the onscreen image of the desired Sample Rack and
select Rack Details.
The Sample Rack Loading screen opens for the selected Sample Rack.
2. From the Sample Rack Loading screen, click the specimen of interest or
select the Sample Details/Edit button and select the specimen of interest.
The Sample Details screen opens with the current test orders for the
selected specimen.
3. Select the test order to be designated as STAT from the Test Orders panel.
4. Select STAT Test Order.
The STAT designation updates to Yes in the STAT column.
5. Repeat Steps 3–4 to prioritize test orders for STAT for any additional test
orders in the selected specimen tube.
To add the STAT designation to a sample rack:
1. From the Sample Rack Bay screen, click the loaded rack with the specimen
(s) of interest or select the onscreen image of the desired Sample Rack and
select Rack Details.
The Sample Rack Loading screen opens for the selected Sample Rack.
2. From the Sample Rack Loading screen, select the STAT All button.
A Set STAT for Rack window appears to confirm the STAT priority will be
applied to test orders for all specimens on the rack.
3. From the Set STAT for Rack window, select the YES button to continue.
STAT designation is applied to all specimens in the sample rack in the
Sample Rack Bay screen.
4. Repeat Steps 1–3 to set STAT priority for any additional sample racks.

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Running Controls/Calibrators as Specimens

To process Hologic controls/calibrators as specimen tubes (i.e., only report results of

the control or calibrator and not use them to validate an assay kit or associated
specimen):
1. From the Sample Rack Bay screen, do one of the following:
l Double-click the onscreen image of the desired Sample Rack.

l Select the onscreen image of the desired Sample Rack and then select

Rack Details.
The Sample Rack Loading screen opens.
2. If any true controls or calibrators are included in the selected Sample Rack, do
one of the following:
l Double-click the onscreen image of the desired control or calibrator tube.

l Select the Sample Details/Edit button and then select the onscreen image

of the desired control or calibrator tube.

The Sample Details screen opens.
3. Check the Process as Specimen box.

Figure 65. Process as Specimen Checkbox (Example)

The selected control or calibrator can now be processed as a specimen.
4. Add a test order to the control or calibrator following the instructions in the Adding
a Test Order section (see Adding a Test Order on page 123).
5. Repeat Steps 2–4 as necessary for additional control or calibrator tubes.

Dilution Factors

Note—This feature is not available for all system software configurations.

If the system has quantitative assays installed, options are available to create and
apply dilution factors to quantitative assay test orders. Dilution factors can only be

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applied to quantitative assay test orders before processing has begun on the test
order. Test orders with dilution factors are flagged with the corresponding dilution
factor identifier. The results for the test orders with dilution factors will be displayed in
the original concentration value, with the assay result multiplied by the specified
dilution factor.

Warning—Ensure that dilution factors are applied properly, according to

the dilutions made for the specimens. It is the responsibility of the user to
properly dilute specimens and to apply the dilution factor accordingly.

Apply Dilution Factors

Note—For additional information on custom dilution factors, refer to

the appropriate Panther System Software Application Sheet.

To add 1:3 or 1:100 dilution factors to quantitative assay test orders so that the
final results are listed at original concentrations:
1. If applying dilutions to an entire rack of quantitative specimens, from the
Sample Rack Loading screen select Apply Dilution All.
If applying dilutions to a single test order, select the test order from the
Sample Details screen and select Apply Dilution.
The Dilution Factor window opens.
2. From the Dilution Factor window, select a previously created dilution factor.
3. Select OK.
Note—If dilutions were added to the entire rack, a Set Dilution
Factor for Rack window appears to confirm selected dilution factors
will be added for all specimens in the Rack. Select Yes to continue.

The corresponding dilution factor flag will be applied to all selected test
orders.

Delete Dilution Factors

Dilution factors can be removed from test orders prior to the start of processing
the test order.
To delete dilution factors from quantitative assay test orders:
1. From the Sample Rack Bay screen, click the loaded rack with the specimen
(s) of interest.
The Sample Rack Loading screen opens for the selected Sample Rack.
2. From the Sample Rack Loading screen, double-click the specimen of
interest.

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The Sample Details screen opens with the current test orders for the
selected specimen.
3. Select the test order of interest from the Test Orders panel.
4. Select Apply Dilution.
5. From the Dilution Factor window, clear the check for the previously selected
dilution factor.
6. Select OK to delete the dilution factor from the test order.
To delete dilution factors from an entire rack:
1. From the Sample Rack Bay screen, double-click the loaded rack of interest.
The Sample Rack Loading screen opens for the selected rack.
2. Select Apply Dilution.
3. From the Dilution Factor window, clear the check for the desired dilution
factor.
4. Select OK to delete the dilution factor from the test order.

Unloading Sample Racks

Unload Sample Racks from the system when pipetting has finished for the rack. All
sample icons are blue on the Sample Rack Bay and Run Status screens and the Sample
Bay Lane LED is disabled once sample pipetting has been completed on a Sample Rack.

Warning—Do not remove Reagent or Sample Racks that are currently in

use by the system. Do not remove racks when the lane LED is red and the
rack graphic on the screen is yellow with a red border.

To unload Sample Racks:

1. Open the Sample Bay Door.
The Sample Rack Bay screen opens.
2. From the Sample Rack Bay screen, ensure that the sample icon(s) of the rack(s) to be
removed are not yellow.
3. Ensure that the Sample Bay Lane LED(s) of the rack(s) to be removed are not red.
4. Pull the rack by the handle and remove it from the Sample Bay Lane.
The rack and tube icons on the screen turn gray.
5. Remove up to eight (8) Sample Racks as necessary following Steps 2–4. Multiple
racks can be removed at the same time if the criteria in Steps 2 and 3 are met.
6. If necessary, load fresh Sample Racks into the empty Sample Bay Lanes (see
Loading Sample Racks on page 121).
7. Close the Sample Bay Door.

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Initiating Assay Processing

The system automatically initiates assay processing when the following requirements
have been met:
l The system is in the Ready state.
l Adequate consumables are available.

l The required assay reagent kit is loaded on the instrument.

l Associated control or calibrator sets have been loaded or there are valid

control/calibrator results for the assay reagent kit.

l All drawers and doors have been closed.

Once these conditions have been met, the system transitions into the Assay Processing
state. Sample processing begins after onboard TCR mixing has completed. The samples
will be processed based upon load order and processing efficiency. Continue to monitor
and manage sample pipetting, control/calibrator validity and reagent validity by referring
to the Run Status screen. Continue to monitor and manage the status of the consumables
by referring to the consumable inventories in the Status Panel.

Pausing Sample Pipetting

Pause sample pipetting as needed.
To pause sample pipetting:
l From the Sample Rack Bay screen, select Pause.
Sample pipetting pauses after the completion of pipetting for the MTU in
progress. Sample pipetting remains paused until the user reinitiates sample
pipetting.
Warning—Do not remove the Sample Rack that is currently being
processed from the Sample Bay when the system is paused.

Assay processing activities for all pipetted samples continue while the sample
pipetting is paused. Select Resume to continue sample pipetting.

Resume Pipetting Following Pause

To restart sample pipetting following a pause:
l Select Resume.
Sample pipetting resumes.

Monitoring the System through Hardware

Use the LEDs and the system alarm to help monitor the system status. Monitor the
information provided by these items to ensure the proper functionality of the system.

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System LEDs
Two (2) LED indicators are located on the upper left and right corners of the
canopy. These LED indicators alert the user to the system's current status
according to the LED status in the following table.
Table 56. System LED Status Color Legend
LED Color Meaning

Solid The system is in the Ready, Setup, Priming,

Green Maintenance, or Assay Processing state.

There are messages on the Pending screen. The

Flashing
system requires resources to complete assay
Green
processing.

Flashing
The system is in an error state.
Red

The system is powered down or is in a state other

Off than the Ready, Setup, Priming, Maintenance,
Assay Processing, or an error state.

Reagent Bay Lane LEDs

Four (4) LED indicators are located on the top of the Reagent Bay Door. The
Reagent Bay Lane LEDs change color according to the following table.

Table 57. Reagent Bay Lane LED Status Color Legend

LED Color Meaning

Off Reagent Bay Lane is empty.

Flashing Reagent Bay Lane is available for loading.

Green

Green Reagents are loaded and available for use.

Red Reagents in rack are currently being pipetted.

Do not remove Reagent Rack from this lane.

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Table 57. Reagent Bay Lane LED Status Color Legend (Continued)
LED Color Meaning

Flashing Reagent Bay Lane is in an error state.

Red

Sample Bay Lane LEDs

Eight (8) LED indicators are located on the top of the Sample Bay Door. The
Sample Bay Lane LEDs change color according to the following table.
Table 58. Sample Bay Lane LED Status Color Legend
LED Color Meaning
Off Sample Bay Lane is empty or all test orders have
been pipetted from the loaded Sample Rack.

Flashing Sample Bay Lane is available for loading.

Green

Green Samples are loaded and available for further

processing.

Red Samples in rack are currently being pipetted

Flashing Sample Bay Lane is in an error state.

Red

Tip Drawer, TCR Door, and MTU Input Queue LEDs

One (1) LED indicator is located on the top of each Tip Drawer and the TCR
Door. One (1) LED indicator is also located on the front of the MTU Input Queue.
These LEDs change color according to the following table.

Table 59. Tip Drawer, TCR Door, and MTU Input Queue LED Status
Color Legend
LED Color Meaning
Green The drawer or door is unlocked.

Red The drawer or door is locked.

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System Alarm
The system produces two (2) levels of audible alarm depending upon the
severity of the issue. Refer to the Messages screen to silence the alarm and
view information regarding the reason for the alarm (see Messages Screen on
page 53).

Monitoring the System through Software

Monitor the system software through the numerous software displays. The following
items display status information for the system. Monitor the information provided by
these items to ensure the proper functionality of the system.

Monitoring the Menu Bar

Monitor the buttons on the Menu Bar for a change in status according to the
following table.
Table 60. Menu Bar Status Descriptions
Display Item Description

Messages The button, located in the Menu Bar, displays the

number of system messages. The black number on the
button represents the total number of Information
messages currently displayed on the Messages
screen. The yellow number represents the total number
of Warning messages currently displayed. The red
number represents the total number of Error messages
currently displayed.

Pending The button, located in the Menu Bar, displays the

number of pending messages on the Pending screen.
This button flashes yellow when Pending messages
remain on the Pending screen.

Tasks The button, located in the Menu Bar, flashes yellow

when one of the Task Buttons on the Tasks screen is
flashing red.

Test Orders The button, located in the Menu Bar, displays the
number of reflex test orders that require the user to
reload the associated specimen tube. This button
flashes yellow when reflex test orders remain on the
Test Orders screen.

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Table 60. Menu Bar Status Descriptions (Continued)

Display Item Description

Question Mark The question mark symbol is displayed on shaded

buttons that are not currently accessible. Select the
shaded button to view the reason the associated task
cannot be performed.

Monitoring the State Indicator

The yellow System State Indicator at the top right of the screen provides the
current state of the instrument. Use the system state to determine the availability
of the system for system activities.

Table 61. System State Indicators

State Meaning Occurrence

Initialization The system and A progress bar displays during

software are this state and no program
initializing. The features or functions are
system is in this available.
state at start-up.

Setup The system is The system is in this state after

available for the system and software have
performing been initialized or have returned
instrument to an idle state.
preparation
activities.

Priming This system is The system is in this state after a

Instrument currently prime has been initiated
priming the fluid manually or automatically.
lines. The
operator cannot
perform waste
or fluid-related
tasks while the
system is in this
state.

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Table 61. System State Indicators (Continued)

State Meaning Occurrence

Ready The system is The system is in this state after

ready to all tasks have been completed in
perform assay preparation for processing
processing. samples.

Maintenance The system is The system is in this state as

performing maintenance tasks are being
semi- performed.
automated or
automated
maintenance
operation. The
operator cannot
perform waste
or fluid-related
tasks while they
system is in this
state.

Assay The system is The system is in this state when

Processing processing samples are processing. This
samples. The mode continues through
operator cannot specimen pipetting, assay
perform waste processing, and results
or fluid related processing.
tasks while the
system is
system is in this
state.

Power Save The system is The system enters this state

in reduced through the Logoff/Shutdown
power mode. screen or according to Power
The operator Save configuration settings. Exit
continues to this state through the
have access to Logoff/Shutdown screen, via
data while in Power Save configuration
this state. settings, or by loading or
removing a Reagent Rack.

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Table 61. System State Indicators (Continued)

State Meaning Occurrence

Error–No A system error The system is in this state after

Data Access has occurred. the system has experienced a
The operator database integrity or software
cannot perform self-test failure.
any data
access
activities other
than sending
logs.

Error–Assay A system error The system transitions from this

Processing has occurred. state to the Error–Data Access
Completing Current MTUs Only state when all MTUs have
not affected by completed processing.
the error will
continue to
process.

Error–Data A system error The system is in this state after

Access Only has occurred. the system has experienced an
The operator unrecoverable error.
continues to
have access to
data. The
operator can
also unload
reagents and
samples.

Shutdown The system is The system is performing all

shutting down. required operations to ensure
that it is in a safe state when all
communication activities with the
instrument have terminated.

Monitoring the Status Panel

Monitor the Status Panel for system activities, consumable inventory, and
modules associated with the icon.

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Status Panel

The status panel includes the consumable inventory panels, system activity
updates, user name, status icons, the date and time, and the Print Screen
button. The Status Panel is always present at the bottom of the screen. Use the
panel for tracking consumable inventory and for loading consumables.

Figure 66. Status Panel (Example)

Status Panel Bars

The Status Panel contains five (5) status panel bars that track inventory of
consumables on the system. These panels display the current number of tests
available. Information for doors or drawers associated with the consumables is
also provided in the bars.

Table 62. Status Bar Updates

Status Bar Meaning of Information on Status Bar

Tip Count Displays the total number of pipette tips

available and the status of the Tip Drawers.
The status bar turns red when the drawer(s) are
open or there are no tips remaining. The status
bar turns yellow when there is one (1) rack of
tips (96) remaining in the inventory.

MTUs Displays the total number of MTU tubes

available based upon the number of tubes per
MTU (5). Also shows the status of the MTU
Input Queue. The status bar turns red when the
MTU Input Queue is open or there are no
MTUs remaining. The status bar turns yellow
when there are 10 MTU tests remaining in the
inventory.

Waste Displays the total waste capacity available and

the status of the Waste Drawer. The status bar
turns red when the Waste Drawer is open. The
status bar changes to yellow when the Waste
capacity is below the configurable Waste
Threshold (see Threshold Management on
page 220).

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Table 62. Status Bar Updates (Continued)

Status Bar Meaning of Information on Status Bar

Fluid Kit A Displays the total number of tests available for

fluid kit A and B, as well as the status of the
Universal Fluids Drawer. The status bar turns
red when the Universal Fluids Drawer is open
or the kit is invalid. The status bar turns yellow
when there are less than 48 hours of kit stability
Fluid Kit B remaining.

System Activity Updates

The System Activities tracker in the Status Panel displays the current system
task being performed and the time that the task will finish. Progress bars are
displayed in this area for the following system tasks:
l Initialization
l Unload
l Automated or semi-automated maintenance tasks
l Prime
l Unlocking MTU Drawer
l Preparing TCR Carousel for Loading (in Assay Processing state)
l Shutdown

Additional Status Panel Icons

The Status Icons at the bottom right of the Status Panel alert the operator to
when certain components or connections are not functioning properly. Icons with
a red strike-through indicate that a component is not functioning within
specification or is not in a state necessary for transition into assay processing.
Unmarked icons indicate that the component is functioning normally.

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Table 63. Status Icon Descriptions

Icon Meaning of Red Icon

Temperature—Status of the internal temperature and

incubator temperatures. A red strike-through indicates a
monitored temperature is out of range. Selecting this icon
transitions the operator to the Temperatures and Sensors
screen.

Vacuum—Status of the vacuum pressure. A red strike-

through indicates the vacuum pressure is out of range.
Selecting this icon transitions the operator to the
Temperatures and Sensors screen.

Doors—Status of the doors and drawers. A red strike-

through indicates that one of the doors or drawers is open.
Selecting this icon transitions the operator to the
Temperatures and Sensors screen.

USB Drive—The icon is displayed when a USB drive has

been inserted and is recognized by the system. Select this
button before physically removing the USB drive to properly
unmount the USB drive. The icon will disappear once the
USB drive connection has been terminated.

LIS—The icon is displayed when the system is connected to

an LIS. The icon will disappear if the LIS connection has
been disabled.

Remote Diagnostics—The icon is displayed when a

Hologic specialist is connected to the system during a
Remote Diagnostic Session. Selecting this icon transitions
the operator to the PRO360° Software window.

UPS—The icon is displayed when the Enable UPS

Shutdown functionality is enabled. Selecting this icon
displays the charge status of the connected UPS. A flashing
icon indicates that the UPS is not connected to the system.

Printer—Status of the printer. A flashing icon indicates that

the printer needs operator attention.

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Table 63. Status Icon Descriptions (Continued)

Icon Meaning of Red Icon

Comments—The icon is displayed when a message is

available on the Comments screen. The Comments screen
may be accessed from the Messages screen.

Figure 67. Temperatures and Sensors Screen (Example)

Monitoring Pending Tasks

Monitor Pending notifications from the Pending screen. Complete the tasks to
initiate sample processing on specimens with associated pending items.

Monitoring Reagent Status

Use the following screens to monitor the status of loaded assay reagent kits.

Panther Assay Reagent Bay Screen

Monitor reagent loading and assay reagent kit usage on the Panther Assay
Reagent Bay screen. The reagent lane graphics on the screen update according
to the color legends below.

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Table 64. Reagent Rack Status Color Legend

Icon Color Meaning
Purple
Reagent Bay Lane is available for loading.
Border

Blue Border Reagent Bay Lane has been selected.

Reagent Rack is currently being pipetted by the

Red Border
system.

Red Rack Invalid Reagent Rack entry.

Table 65. Assay Reagent Status Color Legend

Icon Color Meaning

Gray No Reagent Rack is loaded.

Reagents have been successfully loaded and are

Green
ready for use.

Reagent kit is currently being pipetted by the system.

Yellow
Do not remove the Reagent Rack from this lane.

Red Invalid reagent.

Assay Reagent Loading Screen

The Assay Reagent Loading screen, accessible through the Panther Assay
Reagent Bay screen, provides detailed information on the selected assay
reagent kit.

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Figure 68. Assay Reagent Loading Screen (Example)

Run Status Screen

The Assay Reagents panel on the Run Status screen provides important assay
reagent kit status information including the status of the control/calibrator set
associated with the assay reagents. Refer to this panel for assay reagent kit and
control/calibrator set expiration information.

Figure 69. Assay Reagents Panel (Example)

Monitoring Test Orders

Use the Test Orders screen to monitor the status of test orders prior to pipetting.
The columns on the Test Orders screen can be sorted as needed. Select a filter
category on the top of the table to configure the display so that only the desired
data is shown. Refer to the screen for test order information, including order
timing, status, assay types, and chosen analyte types.

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Figure 70. Test Orders Screen (Example)

Viewing Test Orders

The table on the Test Orders screen displays the following information for each
test order:
Table 66. Test Order Screen Fields
Test Orders Column Meaning

Identification for the sample from the barcode,

Sample ID
manual entry, or auto-generation.

Assay Assay associated with test order.

Order Date/Time The time that the test order was generated.

Analytes Analyte(s) requested in the test order.

Status Test order/sample status.

Test Order Status

The test order status is documented in the Status column on the Test Orders
screen. Once the test order has been pipetted from the sample tube, the test

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order is no longer tracked on the Test Order screen. Use the Results screen for
further tracking of the test order. The status descriptions listed on the Test Order
screen are defined in the table below.
Table 67. Test Order Status Definitions
Status Meaning

Test order is recognized by the system but is not

Requested
associated with a loaded sample.

Test order has been associated with a loaded

Loaded
specimen.

Scheduled Pipetting has been scheduled for the test order.

Monitoring Loaded Specimen Status

Use the following screens to monitor the status of loaded samples.

Sample Rack Bay Screen

Monitor sample loading and sample pipetting from the Sample Rack Bay
screen. The sample lane graphics on the screen update according to the color
legends below.

Table 68. Sample Rack Status Color Legend

Icon Color Meaning

Purple Border Sample Bay Lane is available for loading.

Blue Border Sample Bay Lane has been selected.

Sample Rack is currently being pipetted.

Red Border Do not remove the Sample Rack from this
lane.

Red Rack Invalid Sample Rack entry.

Gray No Sample Rack is loaded.

White No test order for the loaded sample.

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Table 68. Sample Rack Status Color Legend (Continued)

Icon Color Meaning

Black Empty sample position.

Test order(s) have been associated with sample

Green
tube.

Sample is currently being pipetted by the system.

Yellow Do not remove the Sample Rack from this
lane.

Red Invalid sample.

Blue Pipetting of all associated test orders is complete.

Sample is not able to be run due to an associated

pending item. The "P" is removed after the
"P"
associated pending item(s) have been
addressed.

"C" Control or calibrator tube.

Sample preparation error occurred during

processing. Refer to associated message on the
"E"
Messages screen for cause of the error. Retest
affected sample as necessary.

Specimen tube with a test order of a configured

screening assay (assay type found in the Assay
"R" column on the Reflex Testing Configuration
screen). The "R" is removed after the reflex test
designation process has been completed.

Note—The tube icon may appear as green,

yellow, or blue, depending on pipetting status.

Run Status Screen

Use the Run Status screen to monitor sample status and run processing for
samples currently loaded on the system. The panels on the Run Status screen
provide information for the loaded samples, results timing, assay reagents, and
control/calibrator status.

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Figure 71. Run Status Screen (Example)

The Sample Rack graphics on the Run Status screen is linked directly to the
Sample Rack Bay screen. Select this area of the screen to transition to the other
screen as needed.

Specimen Status

Specimen status is documented in the Status column on the Results, Test

Orders, and Sample Details screens. The Status field is updated depending on
the current status of the specimens. The status categories listed in this column
are defined in the table below.

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Figure 72. Sample Status Locations (Example)

Table 69. Specimen Status Definitions
Status Meaning

Requested Test order is recognized by the system but the

sample has not been loaded.

Loaded Specimen is loaded on the system.

Scheduled Test order has been scheduled for the loaded

specimen.

Pipetted Test order has been pipetted from the sample tube.

In Process Test order for specimen is currently being

processed.

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Table 69. Specimen Status Definitions (Continued)

Status Meaning

Completed Results information is available for the test order.

Invalid Sample preparation error occurred during

processing. Refer to associated message on
Messages screen for cause of error. Retest affected
sample as necessary.

Specimens Panel

On the Run Status screen, the Specimens panel details the number of test
orders currently onboard the instrument as well as the number that have
associated pending notifications and missing test orders.

Figure 73. Specimens Loaded Panel—Without LIS (Example)

When connected to an LIS, the Specimens panel displays additional information
for loaded specimens regarding test order assignment through the LIS. The No
Test Request Received from LIS field is populated only when loaded
specimens have not been assigned a test order. The graphics for samples
without test orders appear as white on the Run Status screen.

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Figure 74. Specimens Loaded Panel—With LIS (Example)

Monitoring Control/Calibrator Status

Table 70. Control/Calibrator Status Definitions

Status Meaning

Loaded Control/calibrator set has been

loaded.

Valid Processing of the control/calibrator set

is complete and the results are valid.

Invalid Control/calibrator set failed due to a

hardware or assay validation failure.

In-Process Control/calibrator set is processing.

Expired Control/calibrator results test validity

period has expired.

Pending A control or calibrator assigned a

Pending label will be designated as
white on the rack display.

Assay Reagents Panel

The control/calibrator set status can also be monitored from the Assay Reagents
panel on the Run Status screen. The Expiration column displays the expiration
countdown time of the control/calibrator set associated with the assay reagent
kit.

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Figure 75. Assay Reagents Panel (Example)

Monitoring Results Timing

The time to result is displayed for each order in the Completion Time column
on the Results screen (see Results Screen on page 73). The column is updated
to reflect any changes in assay processing.
The Results panel on the Run Status screen provides the number of sample
results generated during the time that the instrument last transitioned to the
Assay Processing state (see Run Status Screen on page 70).

Figure 76. Results Panel (Example)

The number of results displayed in the Results field resets the next time the
system transitions out of the Assay Processing state. The time for the last result
will update as new samples are loaded onto the system.

Results Management
The system generates a unique result for each processed test order. View, edit, verify,
compile, and export results according to the guidance provided in this section.

Viewing Results
Use the Results screen to view test results. Results are available for viewing
immediately following the completion of assay processing. The Results screen can
be used to monitor all test order parameters including the sample status, completion
time, associated assay, results flags, LIS status, rack position and worklist ID. The
Sample Curve Report is available depending on certain software configurations.

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Figure 77. Results Screen—Expanded (Example)

Results Information

The table on the Results screen displays the following information for each test
order.
l Sample ID—Identification for the sample from the barcode, manual entry, or auto-
generated sample IDs.
l Completion Time—The completion time for the result.
l Assay—Assay associated with test result.
l Status—Sample status (see Monitoring Loaded Specimen Status on page 144).
l Result Flags—System-generated codes applied to the test (see Results
Processing Flags on page 283).
l Result 1–6—RLU and analyte result data is displayed in these columns. Test
results provided in these columns are dependent upon Assay type.
l Sample Type—Sample category (e.g. specimen, calibrator, control, external
quality control).
l LIS Result Status—Data status in regards to LIS transmission.
l Verified—Verified data status (True or False).
l Rack and Pos—Sample Rack ID number and tube position within the rack from
where the sample was pipetted.
l Worklist ID—ID number associated with all samples that were tested against the
same set of controls/calibrators. The worklist ID follows the naming convention:
XXXXX[Serial Number]- YYYYMMDD[Datea]-XX[2digitSeqNumb]

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a = The date that the first control/calibrator was pipetted.

b = Sequential run number starting with 01 for the first worklist started on the
date.

Sample Curve Report

Note—This feature is not available in all system software configurations.

Additional information for specimens tested with real-time assays can be found in the
Sample Curve Report. The report contains a result summary that is specific for the
specimen including reagent information and a chart of the normalized representation
of the specimen's fluorescence profiles over the course of the reading frame. The
curve chart contains Relative Fluorescent Unit (RFU) data on the Y axis as
measured over time on the X axis.
Results data contained in this report can also be found on the Results screen and
through related results reports found on the Report Menu screen (see Results Screen
on page 73 and see Report Menu Screen on page 75).
To access the Sample Curve Report:
1. From the Results screen, select the row of the test order.
2. Select Curve Data.
A window opens that contains the Sample Curve Report.

Figure 78. Sample Curve Report (Example)

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This report can be navigated, printed, and exported in the same manner as other
reports (see Navigating Reports on page 163). The default name of the .pdf data file
for the Sample Curve Report is as follows:
Curve<Report Export Time>.pdf
For example, a report that was exported on February 23, 2012, at 11:30:26 AM would
be named:
Curve20120223-113026.pdf

Result Details
Additional information for a selected test order can be accessed through the Result
Details window. The Result Details window provides supplementary information for
the chosen test order that is not available on the Results screen.
Several items displayed on the Result Details window are already displayed on the
Results screen. A description of these items is detailed in the Results Information
section (see Results Information on page 151). The items that are unique to this
window are detailed below.
To access the Result Details window:
1. On the Results screen, select the row of the test order.
2. Select Details.
A Result Details window opens that contains additional system information for
the selected test order.
Note—Not all of the items listed here will be found for each sample selected.
Items displayed in the Result Details window are dependent upon the
sample-type selected.

l Load Date/Time—When the sample associated with the test order was loaded
onto the instrument.
l Pipetting Date/Time—When the test order was pipetted into an MTU by the
instrument.
l Assay Reagent Kit Lane—The Reagent Bay Lane number of the assay reagent
kit that was used to process the test order.
l Master Lot Number—The Master Lot number of the assay reagent kit that was
used to process the test order.
l Universal Fluids—The Fluid Kit (A or B) that was used to process the test order.
l MTU ID—The identification number of the MTU that the test order was pipetted
into.
l Position in MTU—The tube position of the MTU (1-5) that the test order was
pipetted into.

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l Operator—The user name(s) of the operator(s) that performed any system tasks
associated with the test order.
l Results DB ID—System database identification number for the result.
l Test Order DB ID—System database identification number for the test order.
l Sample DB ID—System database identification number for the sample.
l AR Kit DB ID—System database identification number for the assay reagent kit
used to process the test order.
l Order Type—The way in which the test order was assigned to the specimen.
Possible values are below:
1. LIS—The test order was assigned through the connected LIS.
2. Automatic—The test order was assigned based upon the Sample Defaults
setting.
3. Manual—The test order was assigned through the Sample Details or the
Sample Rack Loading screen.
lAssay Version—Assay software version used to process the test order.
3. Select Done to return to Results screen.

User Comment
Record comments for invalid controls or calibrators through the User Comment
functionality on the Results screen.
To add a user comment to an invalid control or calibrator:
1. From the Results screen, select the row of the desired invalid control or calibrator.
2. Select User Comment.
The Add or Update User Comment window opens.
3. Select the open space on the window and then enter the comment using the
virtual keyboard.
4. When finished entering the note, select OK or Enter on the virtual keyboard.
5. Select Accept when finished adding the comment.
The information is then associated with the result record and can be viewed
through the Results screen by selecting the User Comment button again.

Filter Results
Select Filters on the top left of the table to filter the display so that the desired
information is shown. After selecting Filters, select the appropriate button and
provide the necessary information. Filter categories can be used in combination.

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Figure 79. Results Screen with Filters Panel (Example)

Verifying Results
Once a result has been produced for a test order, it can be verified. After a result has
been verified, no further edits can be made to manually entered or auto-generated
sample IDs. If the Enable Result Verification configuration is enabled, results
cannot be exported to an LIS unless they have been verified (see Enable Result
Verification on page 227).
To verify a worklist:
1. On the Results screen, select the row(s) of the sample result(s).
2. Select Verify.
The system changes the Verified status from "False" to "True." The sample
information can no longer be edited.

Editing Auto-Generated or Manually Entered Sample IDs

If the sample ID was entered either manually (via virtual keyboard or Nonbarcode
Sample Loading) or by using auto sample ID assignment settings, sample IDs can
be changed as long as the sample data has not yet been verified. Follow the
instructions below on how to edit certain sample IDs. (see Enable Auto Sample ID
Assignment for Unreadable Barcodes on page 224).
To edit a sample ID:
1. From the Results screen or the Test Orders screen, select the row of a specimen
with a system-assigned ID.
The Edit Sample ID (Results screen) or Edit (Test Orders screen) button
becomes enabled.
2. Select Edit Sample ID or Edit, as appropriate.
An Edit Test Order confirmation window opens.
3. Select the sample ID field to use the virtual keyboard to enter the sample ID for
the selected specimen. Enter the information on the virtual keyboard and select
OK when finished.
4. Select Accept.
The Results or Test Orders screen updates to reflect the change.

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Data Export
Export data to a drive location or to a USB flash drive. The system is equipped with
four (4) USB ports. The USB ports are located on the right of the instrument, near the
connection point for the monitor arm. There are also two (2) additional USB ports
located on the computer. Only use USB flash memory drives that meet the following
criteria.
l The USB flash memory drive must not be NTFS (New Technology File System)
formatted.
l The USB flash memory drive must not have pre-loaded software.
l The USB flash memory drive must be dedicated for use with Panther System
files. Do not use the designated USB flash memory drive with other file types.

Exporting to a USB Flash Drive

1. Insert a USB flash memory drive into a free USB port prior to exporting data
from the instrument.
2. The USB drive symbol appears in the Status panel once the system
recognizes the connection (see Additional Status Panel Icons on page 49).

Removal of a USB Flash Drive

1. From the Icon Status Panel, select the USB Drive icon .
The USB Storage Removal window opens.

Figure 80. USB Storage Removal Window (Example)

2. Select the device to be removed.
3. Select Unmount.
A confirmation window opens.

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4. Remove the USB flash drive.

5. Select OK to confirm the removal of the USB flash drive.

Exporting Raw Data

Export kinetic data for the selected test results from the Results screen.
To export raw data:
1. From the Results screen, select the row(s) of the desired result(s).
The Export Raw Data button becomes enabled.
2. Select Export Raw Data.
The Raw Data Export window opens.
The Output Directory field lists one of the following locations:
l The network destination selected on the Data Export Management
menu of the System Configuration screen (see Raw Data Export
Directory on page 230).
l The USB drive location (E:\) if a USB disk is installed.

3. Select the file directory button , select a new export location, and select
OK, if necessary.
A directory opens to allow for changes to the desired file destination.
4. Select OK.
The system exports the kinetic data to the chosen export file location.
The default name of the raw data file follows the naming convention:
RawData-<Raw Data Export Time>-LUMI.csv
For example, a report that was exported on February 23, 2012, at 11:30:26
AM would be named:
RawData-20120223-11.30.26-LUMI.pdf

Note—If saving to a USB flash drive, wait until the "Update In

Progress" notification clears before removing the USB flash drive to
avoid data corruption (see Removal of a USB Flash Drive on page
156).

Exporting LIS Data

Export LIS data for the selected test results from the Results screen. If the
Enable Result Verification configuration is enabled, LIS results cannot be
exported until they have been verified (see Enable Result Verification on page
227).

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To export LIS data:

1. From the Results screen, select the row(s) of the desired sample result(s).
The Export LIS Data button becomes enabled.
2. Select Export LIS Data.
The LIS Data Export window opens.
The Output directory field lists one of the following locations:
l The network destination selected on the Data Export Management
menu of the System Configuration screen (see Data Export
Management on page 230).
l The USB drive location (E:\) if a USB disk is installed.

3. Select the field directory button , select a new export location, and
select OK, if necessary.
A directory opens to allow for changes to the desired file destination.
4. Select OK.
The system exports the LIS data to the chosen export file location.
The default name of the LIS data file follows the naming convention:
@Pt2<Instrument Serial Number>-<Time Worklist Initiated>-<Worklist
ID>.lis
For example, worklist 000350-20120223-01 that was initiated on February
23, 2012, at 11:30:26 AM on instrument 00350 would be named:
@Pt200350-20120223-113026-000148000350-20120223-01.lis
Note—If saving to a USB flash drive, wait until the "Update In
Progress" notification clears before removing the USB flash drive to
avoid data corruption (see Removal of a USB Flash Drive on page
156).

Sending Results to LIS

If the LIS configuration Enable Automatic Results Sending is not enabled,
manually send the selected test results to the LIS from the Results screen (see
Results Screen on page 73).
If the Enable Result Verification configuration is enabled, verify the results before
sending (see Enable Result Verification on page 227).
To send data to the LIS:
1. From the Results screen, select the row(s) of the desired result(s). Ensure results
are verified prior to sending if needed (see Verifying Results on page 155).
The Send results to LIS button will be enabled.

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2. Select Send results to LIS.

Export Viral Data

Note—This feature is not available in all system software configurations.

Export raw results data for select real-time assays from the Results screen. The
Export Viral Data button will not be enabled if any non real-time assay results are
selected.
To export raw real-time assay results data:
1. From the Results screen, select the row(s) of the desired result(s).
2. Select Export Viral Data.
The Viral Intermediate Export window opens.
The Output Directory field lists one of the following locations.
l The network destination selected on the Data Export Management menu of
the System Configuration screen (see Data Export Management on page
230).
l The USB drive location (E:\) if a USB disk is installed.

3. If the export location needs to be changed:

a. Select the file directory button ( ).

A directory opens to allow for changes to the desired file destination.
b. Select a new export location and select OK.
4. Select OK.
The system exports the kinetic data to the chosen export file location. The
default name of the viral data file follows the naming convention:
@VLI<Instrument Serial Number>-<Time Worklist Initiated>-<Worklist ID>.csv
For example, worklist 000350-20120223-01 that was initiated on February 23,
2012, at 11:30:26 AM on instrument 00350 would be named:
@VLI00350-20120223-113026-000148000350-20120223-01.csv

Note—If saving to a USB flash drive, wait until the "Update In Progress"
notification clears before removing the USB flash drive to avoid data
corruption (see Removal of a USB Flash Drive on page 156).

Reports Management
This section contains descriptions on how to create reports from the functionality on the
Report Menu screen. Use the filters for each of the available report types to generate a
report that contains the needed information.

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Select the Reports button on the Menu Bar to access the Report Menu screen. All reports
can be created from this screen.
The following table describes the reports available through the Panther System Software:
Table 71. Reports
Report Description

Activity Log Report A report log for all activities performed on

the system over the selected time frame
(see Activity Log Report on page 165).

Assay Reagent Report Contains expiration and stability information

for matched sets of Panther assay reagents
that have been scanned into the system.
Use this report to assist in managing assay
reagent inventory that are on or off the
system (see Assay Reagent Report on
page 166).

Configuration Report Contains a summary of current system

configurations (see Configuration Report on
page 167).

Diagnostics Log Report A report log for all module activity over the
selected time frame (see Diagnostics Log
Report on page 168).

Exceptions by Worklist Contains invalid, equivocal, and positive

Report results for the selected criteria organized by
worklist (see Exceptions by Worklist Report
on page 170).

Exceptions Report Contains invalid, equivocal, and positive

results for the selected criteria (see
Exceptions Report on page 171).

Levey-Jennings Report Contains assay control data for the chosen

assay control/calibrator, or external quality
control data plotted on a Levey-Jennings
chart for the selected duration (see Levey-
Jennings Report on page 173).

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Table 71. Reports (Continued)

Report Description

Lot Search Report Contains all samples associated with the

selected lot of material (see Lot Search
Report on page 175).

Maintenance Checklist A checklist of the maintenance activities

performed for the chosen month (see
Maintenance Checklist on page 176).

Maintenance Log Report A report log for all maintenance tasks

performed on the system over the selected
time frame (see Maintenance Log Report on
page 177).

Messages Log Report A report log for all messages generated by

the system over the selected time frame
(see Messages Log Report on page 178).

Prevalence Report Contains the percent positivity levels for

patient specimens for the chosen assay
type by day across the selected duration
(see Prevalence Report on page 180).

Results by Worklist A comprehensive report for the selected test

Report results organized by worklist (see Results
by Worklist Report on page 181).

Results Report A comprehensive report for the selected test

results (see Results Report on page 182).

Sample Audit Report All test order results and reagent and fluid
lot numbers associated with a selected
sample (see Sample Audit Report on page
184).

Test Count Report Contains the test counts per assay over the
selected timeframe (see Test Count Report
on page 185).

Worklist Lot Report Contains the assay reagent and fluid lot
information for all tests within the selected
worklist (see Worklist Lot Report on page
186).

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Selecting Reports
Select the appropriate parameters from the Report Menu screen to generate the
needed report. Select the report type from the menu and then choose the content
specifications in the associated parameter menu.
To create a report with the desired information:
1. From the Reports screen, select the report type from the Name column in the
Report Menu.
The parameter menu to the right of the screen updates as appropriate for the
chosen report type.

Figure 81. Report Parameters for Results Report (Example)

2. Check the cells in the parameter menu as appropriate to select the desired report
criteria.
Note—For some parameters, checking the cells in the menu will expand
the menu to allow for more specific information to be selected.

3. Select or complete the information fields as necessary for the report type.
Calendars, assay menus, and virtual keyboards will appear on screen as
appropriate.
4. After supplying the parameter information, select View at the bottom of the Report
Menu screen to open the report.
The selected report window opens. Navigate the report by using the navigation
bar located at the bottom of each report. Refer to the Navigating Reports section

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for instructions on how to utilize the Report Navigation Bar (see Navigating
Reports on page 163).

Navigating Reports
All reports contain a Report Navigation Bar at the bottom of each report.

Figure 82. Panther System Report Navigation Bar

Use the navigation bar to assist in viewing and handling the report. When done
working with the report, use the buttons on the Menu Bar to return to other system
tasks.
After opening the desired report, use the following buttons on the Report Navigation
Bar to navigate the report:
Table 72. Report Navigation Buttons
Button Description

Print Select to send the report to the printer.

Export Select to export an electronic copy of the report in .pdf format

to the configured report export directory.

> Select to navigate forward one page in the report.

>| Select to navigate to the last page of the report.

< Select to navigate back one page.

|< Select to navigate to the first page.

Zoom + Select to increase the onscreen magnification of the report.

Zoom - Select to decrease the onscreen magnification of the report.

Printing Reports
Print reports on a connected printer. The selected reports can either be printed
directly from the Report Menu screen or from the Report Navigation Bar.
To print reports:
1. From the Report Menu screen or the Report Navigation bar, select Print.
A window opens with the default settings for the printer.

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2. Make any needed changes to the printer setup.

3. Select the appropriate button in the printer window to start printing.
The system sends the report to the printer.

Exporting Reports
Export reports to a desired drive location. The selected reports can be exported
directly from the Report Menu screen or from the Report Navigation Bar.
To export reports:
1. From the Report Menu screen or the Report Navigation Bar, select Export.
The Report Export window opens with the Output Directory field listing one of
the following locations:
l The network destination selected in the Report Management menu of the
System Configuration screen (see Report Export Directory on page 229)
l The USB drive location (E:\) if a USB disk is installed

2. Select the field directory button , change the export location, and select OK,
if necessary.
A directory opens to allow for changes to the desired file destination.
3. Select OK.
The system exports the report file to the chosen export file location.
The default names of the .pdf data file for each of the report types are as follows:

Report Type File Name

Activity Log Report ActivityYYYYMMDD-HHMMSS*.pdf

Assay Reagent Report AssayReagentYYYYMMDD-HHMMSS*.pdf

Configuration Report ConfigurationYYYYMMDD-HHMMSS*.pdf

Diagnostics Log Report DiagnosticsYYYYMMDD-HHMMSS*.pdf

Exceptions by Worklist ExceptionsWorklistYYYYMMDD-

Report HHMMSS**.pdf

Exceptions Report ExceptionsYYYYMMDD-HHMMSS*.pdf

Levey-Jennings Report LeveyJenningsYYYYMMDD-HHMMSS*.pdf

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Report Type File Name

Lot Search Report LotSearchYYYYMMDD-HHMMSS*.pdf

Maintenance Checklist MaintenanceChecklistYYYYMMDD-

HHMMSS*.pdf

Maintenance Log Report MaintenanceLogYYYYMMDD-

HHMMSS*.pdf

Messages Log Report MessagesYYYYMMDD-HHMMSS*.pdf

Prevalence Report PrevalenceReportYYYYMMDD-

HHMMSS*.pdf

Results by Worklist ResultsWorklistID-YYYYMMDD-

Report HHMMSS**.pdf

Results Report ResultsYYYYMMDD-HHMMSS*.pdf

Sample Audit Report SampleYYYYMMDD-HHMMSS*.pdf

Test Count Report TestYYYYMMDD-HHMMSS*.pdf

Worklist Lot Report WorklistWorklistIDYYYYMMDD-

HHMMSS**.pdf

*Where YYYYMMDD-HHMMSS represents the time the report is generated.

**Where YYYYMMDD-HHMMSS represents the time the worklist is created.

Note—If saving to a USB flash drive, wait until the "Update In Progress"
notification clears before removing the USB flash drive to avoid data
corruption (see Removal of a USB Flash Drive on page 156).

Reports

Activity Log Report

Select Activity Log Report and enter the desired date range on the right of the Report
Menu screen to generate an Activity Log Report. Check one of the three (3) cells in the
Creation Date panel to generate a report that contains all activities that were performed
over the selected date range. Once the filter has been updated, select View, Print, or
Export as desired to access the Activity Log Report.

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Table 73. Activity Log Report—Report Parameters

Filter Description

Creation Date The following three (3) choices are available for use as
a report filter:
l Today
l Yesterday

l Range

Check the cell of the date range desired. Selecting the

Range cell opens a window to refine the date and time
range.

Figure 83. Activity Log Report (Example)

Assay Reagent Report

Select Assay Reagent Report and enter the minimum test number in the Show kits and
discriminatory probe reagents with greater than... field to generate an Assay Reagent
Report, if desired, when selecting Panther. It is not necessary to check this cell and enter
a number to generate a report. Leaving the cell blank will produce a report that includes
all valid assay reagent kits that have been loaded on the system. Select View, Print, or
Export as desired to access the Assay Reagent Report.

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Table 74. Assay Reagent Report—Report Parameters

Filter Description

Show kits and discriminatory probe Check the cell and enter a number for the
reagents with tests greater than... minimum tests required.

Figure 84. Assay Reagent Report (Example)

Configuration Report

Select Configuration Report and select View, Print, or Export as desired to access the
Configuration Report.

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Figure 85. Configuration Report (Example)

Diagnostics Log Report

Select Diagnostics Log Report and generate a Diagnostics Log Report based upon the
five (5) filter categories.
l Creation Date
l Severity

l Priority

l Event ID

l Include non diagnostic messages

It is possible to use only the Creation Date filter category to refine the report. All five (5)
filter categories can be used in conjunction to further refine the report. Check the cells as
appropriate to generate a report that contains all diagnostic logs that match the filter
specifications. Hologic Technical Support can provide guidance on how to set the
specifications in order to produce a log report that is needed for any instrument
troubleshooting (see Appendix D. Support Contact Information on page 398). Once the
filters have been updated, select View, Print, or Export as desired to access the
Diagnostics Log Report.

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Table 75. Diagnostics Log Report—Report Parameters

Filter Description

Creation Date The following three (3) choices are available for use
as a report filter:
l Today
l Yesterday

l Range

Check the cell of the date range desired. Selecting

the Range cell opens a window to refine the date and
time range.

Show both Check either Yes or No to display desired messaging

diagnostic and in the report. Selecting Yes displays additional system
non-diagnostic communication messaging that is not shown on the
messages Messages screen.

Severity The following six (6) choices are available for use as
a report filter:
l Message
l Warning

l Problem

l Critical

l Fatal

l Undefined

Check the Severity cell and then check the cell of the
system message category desired.

Priority The following three (3) choices are available for use
as a report filter:
l High
l Low

l Informational

Check the Priority cell and then check the cell of the
system message category desired.

Event ID Check the Event ID cell and enter the event ID for the
desired message in the open field.

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Figure 86. Diagnostics Log Report (Example)

Exceptions by Worklist Report

Select Exceptions by Worklist Report and choose the Worklist ID and the sorting
preference from the right side of the Report Menu screen for the desired Exceptions by
Worklist Report. Select View, Print, or Export as desired to access the Exceptions by
Worklist Report. This report contains all positive and invalid results for the selected
worklist.
Table 76. Exceptions by Worklist Report—Report Parameters
Filter Description

Worklist ID Select the Worklist ID from the table.

Completion Date Select the From and the To fields and choose the
beginning and end dates of the desired range.

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Table 76. Exceptions by Worklist Report—Report Parameters (Continued)

Filter Description

Sort By The following two (2) choices are available for use as a
report filter:
l Completion Time
l Sample ID

Check the Completion Time cell to sort the test order

results by the time they completed processing. Check the
Sample ID cell to sort the test order results by the sample
ID in ascending order.

Figure 87. Exceptions by Worklist Report (Example)

Exceptions Report

Select Exceptions Report and generate an Exceptions Report based upon the five (5)
filter categories.
l Completion Date
l Assay

l Sort By

l Sample ID

l Verified

It is possible to use only the Completion Date, Sort By, and Assay filter categories to
refine the report. All five (5) filter categories can be used in conjunction to further refine the

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report. Make a selection in the categories of choice and check the cells as appropriate to
generate a report that contains all exceptions that match the filter specifications. Once the
filters have been updated, select View, Print, or Export as desired to access the
Exceptions Report.
Table 77. Exceptions Report—Report Parameters
Filter Description

Completion Date The following three (3) choices are available for use as a
report filter:
l Today
l Yesterday

l Range

Check the cell of the date range desired. Selecting the

Range cell opens a window to refine the date and time
range.

Assay Select the Select button to choose an assay type. Only

one (1) assay type can be selected.

Sort By The following two (2) choices are available for use as a
report filter:

l Completion Time
l Sample ID

Check the Completion Time cell to sort the test order

results by the time they completed processing. Check the
Sample ID cell to sort the test order results by the sample
ID in ascending order.

Sample ID Check the cell and enter the SID in the Sample ID field.

Verified Check the cell and choose either the Yes or No cells as
appropriate for the filter.

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Figure 88. Exceptions Report (Example)

Levey-Jennings Report

Select Levey-Jennings Report to generate a Levey-Jennings Report based upon the

four (4) filter categories:
l Assay
l Completion Date

l Quality Control Type

l Display multiple master lots on same chart

All four (4) filter categories must be defined in order to generate the report. Make a
selection in the categories of choice and check the cells as appropriate to generate a
report that contains all data that match the filter specifications. The mean RLU and RLU
standard deviation statistics on the chart use the data from the selected controls or
calibrators across the selected time range unless viewing an EQC with a configured
target mean and standard deviation. Once the filters have been updated, select View,
Print, or Export as desired to access the Levey-Jennings Report.

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Table 78. Levey-Jennings Report—Report Parameters

Filter Description

Assay Select the Select button to choose an assay type. Only

one (1) assay type can be selected.

Completion Date Select the From field and choose the beginning date of
the range desired. The To field automatically updates to
cover the period one (1) month from the selected date.

Quality Control Check the Manufacturer's Control/Calibrators cell to

Type create a report with data from controls or calibrators that
are required by the selected assay type. Check the
External Quality Controls cell to create a report with
data from EQCs that were designated by the site through
the software.

Display multiple Select Yes to include data from multiple master lots on
master lots on the same Levey-Jennings chart. Select No to separate
the same chart the data into multiple charts organized by the master lot
used to process the control or calibrator.

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Figure 89. Levey-Jennings Report (Example)

Lot Search Report

Select Lot Search Report and enter the Lot Field on the right of the Report Menu screen
to generate a Lot Search Report. Enter the lot number of one of the following materials:
l Master Lot
l MTU Lot

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l Fluid Lot
Check one of the three (3) cells on the parameter menu and then enter the lot information
in the open field of the Show Samples for the Following Lot panel. Once the information
has been entered, select View, Print, or Export as desired to access the Lot Search
Report. The report contains all SIDs that were tested in conjunction with the chosen lot of
material.
Table 79. Lot Search Report—Report Parameters
Filter Description

Lot Selection Check the cell of the desired lot type.

Lot Field Enter the lot number information of the selected lot type with
the virtual keyboard.

Figure 90. Lot Search Report (Example)

Maintenance Checklist

Select Maintenance Checklist and select the appropriate month in the Month field on
the right of the Report Menu screen for a checklist with the completed maintenance tasks
for the selected month. Select View, Print, or Export as desired to access the
Maintenance Checklist.

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Table 80. Maintenance Checklist —Report Parameters

Filter Description

Month Selection Select the month desired.

Figure 91. Maintenance Checklist (Example)

Maintenance Log Report

Select Maintenance Log Report and check one of the three (3) cells in the Activity Date
panel to generate a report that contains logs of all maintenance tasks that were performed
over the selected date range. Once the filter has been updated, select View, Print, or
Export as desired to access the Maintenance Log Report.

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Table 81. Maintenance Log Report—Report Parameters

Filter Description

Activity Date The following three (3) choices are available for use as a
report filter:
l Today
l Yesterday

l Range

Check the cell of the date range desired. Selecting the

Range cell opens a window to refine the date and time
range.

Figure 92. Maintenance Log (Example)

Messages Log Report

Select Messages Log Report and generate a Message Log Report based upon the
three (3) filter categories:
l Creation Date
l Severity

l Event ID

A selection in the Creation Date filter category is required to generate a report. All three
(3) filter categories can be used together to further refine the report, if necessary. Make a
selection in the categories of choice and check the correct cells as appropriate to
generate a report that contains all system messages that match the filter specifications.

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Once the filters have been updated, select View, Print, or Export as desired to access
the Message Log Report.
Table 82. Messages Log Report—Report Parameters
Filter Description

Creation Date The following three (3) choices are available for
use as a report filter:
l Today
l Yesterday

l Range

Check the cell of the date range desired.

Selecting the Range cell opens a window to
refine the date and time range.

Severity The following six (6) choices are available for use
as a report filter:
l Message
l Warning
lProblem
l Critical

l Fatal

l Undefined

Check the cell of the system message category

desired.

Event ID Check the cell and enter the event ID of the

desired message in the Event ID field.

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Figure 93. Messages Log Report (Example)

Prevalence Report

Select Prevalence Report to generate a Prevalence Report based upon the two (2) filter
categories:
l Qualitative Assay
l Completion Date

Both filter categories must be defined in order to generate the report. Make a selection in
the categories of choice and check the cells as appropriate to generate a report that
contains all data that match the filter specifications. Once the filters have been updated,
select View, Print, or Export as desired to access the Prevalence Report.
Table 83. Prevalence Report—Report Parameters
Filter Description

Qualitative Select the Select button to choose an assay type. Only

Assay one (1) qualitative assay type can be selected.

Completion Date Select the From field and choose the beginning date of
the range desired. The To field automatically updates to
cover the period one (1) month from the selected date.

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Figure 94. Prevalence Report (Example)

Results by Worklist Report

Select Results by Worklist Report and choose the Worklist ID and the sorting
preference from the right of the Report Menu screen to generate a report that contains all
test results for the selected worklist. Once the Worklist ID has been selected, select View,
Print, or Export as desired to access the Results by Worklist Report.
Table 84. Results by Worklist Report—Report Parameters
Filter Description

Worklist ID Select the Worklist ID from the table.

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Table 84. Results by Worklist Report—Report Parameters (Continued)

Filter Description

Completion Date Select the From and the To fields and choose the beginning and
end dates of the desired range.

Sort By The following two (2) choices are available for use as a report
filter:
l Completion Time
l Sample ID

Check the Completion Time cell to sort the test order results by
the time they completed processing. Check the Sample ID cell to
sort the test order results by the sample ID in ascending order.
Controls or calibrators will also be displayed at the beginning of
the report, regardless of this selection.

Figure 95. Results by Worklist Report (Example)

Results Report

Select Results Report and generate a Results Report based upon the five (5) filter
categories:
l Completion Date
l Assay
l Sort By

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l Sample ID
l Verified

It is possible to use only the Completion Date, Sort By, and Assay filter categories to
refine the report. All five (5) filter categories can be used in conjunction to further refine the
report. Make a selection in the categories of choice and check the correct cells as
appropriate to generate a report that contains all test results that match the filter
specifications. Once the filters have been updated, select View, Print, or Export as
desired to access the Results Report.
Table 85. Results Report—Report Parameters
Filter Description

Completion Date The following three (3) choices are available for use
as a report filter:
l Today
l Yesterday

l Range

Check the cell of the date range desired. Selecting

the Range cell opens a window to refine the date
and time range.

Assay Select the Select button to choose an assay type.

Only one (1) assay type can be selected.

Sort By The following two (2) choices are available for use
as a report filter:

l Completion Time
l Sample ID

Check the Completion Time cell to sort the test order

results by the time they completed processing.
Check the Sample ID cell to sort the test order
results by the sample ID in ascending order.
Controls or calibrators will also be displayed at the
beginning of the report, regardless of this selection.

Sample ID Check the cell and enter the SID in the Sample ID
field.

Verified Check the cell and choose either the Yes or No

cells as appropriate for the filter.

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Figure 96. Results Report (Example)

Sample Audit Report

Select Sample Audit Report and enter the SID in the Sample ID field on the right of the
Report Menu screen to generate a report that contains all reagent, fluid, and test order
results information associated with the specimen. Once the SID information has been
entered, select View, Print, or Export as desired to access the Sample Audit Report.

Table 86. Sample Audit Report—Report Parameters

Filter Description

Sample ID Enter the SID in the Sample ID field.

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Figure 97. Sample Audit Report (Example)

Test Count Report

Select Test Count Report and select the appropriate date range on the right of the
Report Menu screen to generate a Test Count Report. Once the date range has been
entered, select View, Print, or Export as desired to access the Test Count Report.
Table 87. Test Count Report—Report Parameters
Filter Description

Test Count Select the From and the To fields and choose the
Report Date beginning and end dates of the desired range.
Range

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Figure 98. Test Count Report (Example)

Worklist Lot Report

Select Worklist Lot Report and choose the worklist ID from the right of the Report Menu
screen to generate a report that contains all associated reagents and fluids information for
the chosen worklist. Once the Worklist ID has been chosen, select View, Print, or Export
as desired to access the Worklist Lot Report.
Table 88. Worklist Lot Report—Report Parameters
Filter Description

Worklist ID Select the Worklist ID from the table.

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Figure 99. Worklist Lot Report (Example)

System Shutdown
The shut down buttons are not available when the system is in the Initialization,
Maintenance, or Assay Processing states.
To shut down the Panther System:
1. Unload all Sample Racks (see Unloading Sample Racks on page 129) and all assay
reagents from the system (see Unloading Panther Assay Reagents on page 112).
2. Ensure that the system is not in the Assay Processing or Maintenance state.
3. From the Logoff/Shutdown screen, select Instrument Shutdown or from the
Messages screen, select Shutdown.
A confirmation window opens.

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Figure 100. Shutdown Confirmation Window

4. Select Yes to confirm shutdown.
The Panther System Software properly shuts down to the Desktop Shield screen.
5. From the Desktop Shield screen, select the shutdown icon.
The computer properly shuts down.
6. Use the power switch on the rear left of the instrument to turn the Panther instrument
off.
7. To restart the system, follow the System Startup procedure (see System Startup on
page 92).

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Maintenance
General Maintenance Information
The system must be maintained regularly in order to ensure reliable performance.
Perform maintenance on the system as outlined in this section. Authorized Hologic
personnel will perform supplemental preventative maintenance as scheduled.

Warning—Follow Universal Precautions when performing all

maintenance activities on the Panther System. Always wear proper
protective equipment, including a laboratory coat, gloves (change
frequently), and eye protection.

Caution—Excluding maintenance procedures specifically illustrated in this

manual, which are performed by trained Panther System operators, only
trained authorized technicians should perform maintenance on the system.

Note—Maintenance tasks should be performed in a well-ventilated work

area.

Maintenance Task Summary

Table 89. Maintenance Task Summary
Task Recommended
Maintenance Task Category Frequency

Laboratory Check and Cleaning (see Manual Daily

Laboratory Check and Cleaning on page
198)

Mag Wash Clean (see Mag Wash Clean Automated A minimum of 3

on page 200) Times/Week
Perform daily
following operation

PC Reboot (see PC Reboot Maintenance Semi-Automated Every 7 Days

on page 202)

Clean Sample Shield (see Clean the Semi-Automated Every 7 Days

Sample Shield on page 201)

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Table 89. Maintenance Task Summary (Continued)

Task Recommended
Maintenance Task Category Frequency

Monthly Maintenance (see Monthly Semi-Automated Every 30 Days

Maintenance on page 203)

Replace Mag Wash Cleaning Solution Semi-Automated As Needed

(see Replace Mag Wash Cleaning (Dependent on Mag
Solution on page 209) Wash Cleaning
schedule)

Clean Reagent Racks (see Clean Manual As Needed

Sample Racks and Reagent Racks on
page 211)

Clean Sample Racks (see Clean Sample Manual As Needed

Racks and Reagent Racks on page 211)

Clean Sample Loading Tray (see Manual As Needed

Preparing a Clean Workspace on page
199)

Idle Maintenance (see Idle Maintenance Manual As Needed

on page 210)

Database Maintenance (see Database Manual As Needed

Maintenance on page 211)

Maintenance Activities Screen

Maintenance tasks are organized and initiated through the Maintenance Activities screen.
Schedule and perform maintenance tasks from this screen. The table on the Maintenance
Activities screen provides times when scheduled maintenance activities are due and
when automated maintenance tasks are set to proceed.
Select the Perform Maintenance icon on the Tasks screen to access the Maintenance
Activities screen (see Tasks Screen on page 56).

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Figure 101. Maintenance Activities Screen (Example)

Maintenance Task Details Screen

Information regarding the selected maintenance task is available on the Maintenance
Task Details screen. Access this screen for specific information regarding settings
associated with the task.
Select a maintenance task on the Maintenance Activities screen and then select Details
to access the Maintenance Task Details screen. Select Done to return to the
Maintenance Activities screen.

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Figure 102. Maintenance Task Details Screen—Clean Sample Shield (Example)

Set Maintenance Tasks to Required

Update the maintenance interval of desired tasks to force them to be performed according
to a chosen interval that is less than the defaults, as necessary. It is not possible to
process samples once a required task becomes past due. Only Administrators can
schedule maintenance tasks (see Adding Operator Accounts on page 240). Adjust the
maintenance settings at any time the system is in the Setup or Ready state.
To set a maintenance task to a required interval:
1. From the Maintenance Activities screen, select the maintenance task to be scheduled.
2. Select Edit.
The Edit Maintenance Task screen opens.

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Figure 103. Edit Maintenance Task Screen Mag Wash Cleaning (Example)
3. From the Interval panel, select the Hours, Days, Weeks, Months, Years, or Cycles.
Note—The interval for the Replace Mag Wash Cleaning solution task is
permanently set to the System Monitored setting. This is the only
maintenance task that can be set to this interval category.

4. Select the Every field, enter the number based upon desired maintenance schedule
intervals, and select OK when finished.
Note—Do not select Cycles when configuring the maintenance schedule
intervals. This functionality is not available in this software version.

5. Select Accept to confirm any changes made.

The Due column on the Maintenance Activities screen updates to reflect changes in
scheduling.

Schedule an Automated Maintenance Task

Schedule the Mag Wash Cleaning maintenance task to run automatically when away
from the instrument (see Mag Wash Clean on page 200). The system will only perform the
automated task if all requirements have been met. Only Administrators can schedule an
automated maintenance task (see Adding Operator Accounts on page 240). Adjust the
maintenance settings at any time the system is in the Setup or Ready state.
To schedule an automated maintenance task:
1. From the Maintenance Activities screen, select the maintenance task to be automated.

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 Maintenance

2. Select Edit.
The Edit Maintenance Task screen opens.

Figure 104. Scheduled For Automated Start Panel (Example)

3. Check the Scheduled For Automated Start box.
4. From the Scheduled For Automated Start panel, check and complete the following
items to set a recurring time:
l Week—Select the Every_weeks field, enter the appropriate number on the pop-

up keypad, and select OK when finished.

l Day—Check the day(s) of the week to perform the task.

l Time—Select the time field, set the time of day on the pop-up clock, and select

OK when finished.
5. Select Accept to confirm any changes made.
The Auto Start column on the Maintenance Activities screen updates to reflect
changes to the automated schedule.

Tracking the Maintenance Schedule

The table on the Maintenance Activities screen lists the scheduled maintenance
functions, the status of each function, and the next scheduled due date.

Figure 105. Maintenance Table (Example)

The Auto Start column applies to maintenance tasks that have been scheduled to
proceed automatically.

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Maintenance Reports
The system tracks all maintenance activities that were performed through the
Maintenance Activities screen. This information is logged into the database and can be
printed or exported from the Reports screen in the following reports:
l Maintenance Checklist (see Maintenance Checklist on page 176)
l Maintenance Log Report (see Maintenance Log Report on page 177)

Record Maintenance Comments

Record comments at the completion of a maintenance task within the Comment field on
the Maintenance Task Completed screen.

Figure 106. Maintenance Task Completed Screen (Example)

To record comments:
1. Select the space within the Comment field and then enter the comment using the
virtual keyboard.
2. When finished entering the note, select OK or Enter on the virtual keyboard.
The information is then associated with the task record and can be viewed on the
Maintenance Checklist and on the Maintenance Log Report through the Reports
screen.

Recommended Cleaning Agents

The following table lists the cleaning agents recommended for maintenance procedures.

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Table 90. Recommended Cleaning Agents

Agent Definition Used For

Alcohol 70% ethanol Cleaning the monitor and handheld barcode

scanner
70% isopropyl
alcohol solution
70% isopropyl
alcohol wipes

Sodium 2.5%–3.5% Laboratory: Cleaning work surfaces.

Hypochlorite sodium
Solutions hypochlorite or Panther System: Cleaning the external work
prepared Bleach surfaces and the surfaces of the following
Enhancer instrument components: Reagent Shield,
solution Reagent Bay, Sample Bay, Sample Shield,
Tip Drawers, TCR Cups, TCR Adapters,
Universal Fluids Drawer, NaOCl Bottle
(external surface), Waste Drawer, Liquid
Waste Container (external surface), Solid
Waste Container, instrument external surfaces
(excluding the monitor and handheld barcode
scanner), Reagent Racks and Sample Racks.

2.5%–3.5% Laboratory: Sample spills.

sodium
hypochlorite Panther System: Cleaning the internal
solution surfaces of the following instrument
components: NaOCl Bottle and the Liquid
Waste Container.

Water DI water Rinsing external surfaces of the following

areas/components after cleaning with sodium
hypochlorite solutions:

l Cleaning work surfaces (see Preparing a

Clean Workspace on page 199)

l Surfaces of the Panther Tip Drawer (see

Step 2. Clean the Tip Drawers on page
203)

l Reagent Bay (see Step 3. Clean the

Reagent Bay on page 204)

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Table 90. Recommended Cleaning Agents (Continued)

Agent Definition Used For

l Surfaces of the Sample Bay (see Step 4.

Clean the Sample Bay on page 204)

l Surfaces of the Panther Universal Fluids

Drawer (see Step 5. Clean the Panther
Universal Fluid Drawer on page 206)

l NaOCl Bottle (see Step 5. Clean the

Panther Universal Fluid Drawer on page
206)

l Surfaces of the Panther Waste Drawer and

Solid Waste Container (see Step 6. Clean
the Panther Waste Drawer on page 207)

l Liquid Waste Container (see Step 6. Clean

the Panther Waste Drawer on page 207)

l Instrument external surfaces (see Step 7.

Clean the External Surfaces on page 209)

DI or Tap water Rinsing surfaces of the following components

after cleaning with 2.5%–3.5% sodium
hypochlorite solution:

l Sample Racks and Reagent Racks (see

Clean Sample Racks and Reagent Racks
on page 211)

l Liquid Waste Container (internal surfaces)

(see Step 6. Clean the Panther Waste
Drawer on page 207)

l Sample Shield (see Clean the Sample

Shield on page 201)

l Sample Loading Tray (see Preparing a

Clean Workspace on page 199)

Advanced Endozime Mag Wash Clean task (see Mag Wash Clean
Cleaning Solution on page 200)
Solution

Replacing Mag Wash Cleaning Solution (see

Replace Mag Wash Cleaning Solution on
page 209)

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Preparing Sodium Hypochlorite Solution

Corrosive Warning—Take precautions when working with sodium
hypochlorite solutions. Avoid contact with skin, eyes, and mucous
membranes. Wash affected area with water if contact with this fluid
occurs. Follow laboratory procedures for working with sodium
hypochlorite solutions. Do not autoclave the NaOCl Bottle.

Prepare 2.5%–3.5% sodium hypochlorite solution once a week, if necessary.

To prepare 2.5%–3.5% sodium hypochlorite solution:
1. Calculate the volumes of the starting sodium hypochlorite solution and DI water
needed for the desired volume of 2.5%–3.5% sodium hypochlorite solution according
to equation below.
Volume of Concentration Volume of
Concentration of
Starting of Final Final
Starting Sodium
x Sodium = Sodium x Sodium
Hypochlorite
Hypochlorite Hypochlorite Hypochlorite
Solution
Solution Solution Solution

2. Pour the calculated volume of concentrated sodium hypochlorite solution into an

appropriate final container that is labeled following laboratory procedures.
3. Pour DI water into the same container to bring the solution to the final volume.
Use this solution for applications specified in the Recommended Cleaning Agents
table (see Recommended Cleaning Agents on page 195).

Preparing Bleach Enhancer Solution

If applicable, when using prepared Bleach Enhancer solution, refer to the Bleach
Enhancer for Cleaning package insert for preparation and storage instructions.

Laboratory Check and Cleaning

Perform preparatory cleaning and environmental checks every 24 hours during routine
operation.

Verify that the following environmental specifications are met before initiating testing.
Table 91. Environmental Specifications
Laboratory Specification Low Range High Range

Temperature (°C) 15 °C 30 °C

Relative Humidity (%) 20% 85%

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Preparing a Clean Workspace

Prepare a clean laboratory work surface and Sample Loading Tray before working with
assay reagents or operating the Panther System.
Use 2.5%–3.5% sodium hypochlorite to clean up any sample or fluid spills outside of the
instrument (see Preparing Sodium Hypochlorite Solution on page 198).
To clean the work surfaces:
1. Prepare a cleaning solution of 2.5%–3.5% sodium hypochlorite in DI water weekly or,
if applicable, prepare the Bleach Enhancer solution according to package insert (see
Preparing Sodium Hypochlorite Solution on page 198).
2. Follow the corresponding instructions below depending upon the cleaning solution
used to prepare the work surfaces.

Clean with Sodium Hypochlorite Solution

a. Spray 2.5%–3.5% sodium hypochlorite solution directly onto laboratory work
surfaces and the Sample Loading Tray.
b. Wait one (1) minute and then clean the surfaces with a wipe moistened with DI
water.

Clean with Prepared Bleach Enhancer Solution (if applicable)

a. Wipe down all laboratory work surfaces with a wipe moistened with the prepared
Bleach Enhancer solution.
b. After applying the solution, clean the surfaces with a clean, dry wipe.
c. Repeat steps a and b.
3. Cover the laboratory work surfaces with clean, plastic-backed absorbent laboratory
bench covers (optional).

Checking for Leaks and Spills

Caution—Do not operate the Panther System if it is suspected or found that
liquid has leaked, spilled, or overflowed onto electrical components. Contact
Hologic Technical Support. Do not try to clean the inaccessible parts of the
system without proper assistance.

To check for any leaks in the system:

1. Check the outside of the system for visual signs of damage.
2. Check the floor around the system for signs of fluid leaks or residue.
3. If evidence of a leak, spill, or residue is found, continue as follows:
a. If possible, determine the type of fluid and the source of the leak.
b. Follow laboratory procedures to clean up the fluid.

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c. Make appropriate adjustments where possible. For example, ensure that tubing is
properly connected.
d. If the spill was from an unknown origin or caused by a system problem, contact
Hologic Technical Support.

Mag Wash Clean

The Mag Wash Clean maintenance task removes deposits that can build up inside the
aspirators and associated tubing. This task can be run at any time the system is in the
Setup or Ready state. The task takes 31 minutes to complete and can be scheduled to
run during non-operating hours (see Schedule an Automated Maintenance Task on page
193). If the system is scheduled to run the cleaning task automatically, the system will
transition out of the Power Save state to complete this task.
This task should be performed for the following:
As part of system maintenance

It is required that this task be performed daily after each testing day. For example, if
processing test orders on Monday–Friday, schedule the Mag Wash Clean task to be
run after working hours on Monday–Friday (see Example Mag Wash Maintenance
Tasks Cleaning Schedules on page 200).
As part of the resolution for Mag Wash station errors

If Magnetic Wash aspiration errors occur, perform this procedure following assay
processing or as directed by Hologic Technical Support.
Table 92. Example Mag Wash Maintenance Tasks Cleaning Schedules
Testing Days per Week Mag Wash Clean Task Frequency

2 Set task to be performed 2 times per week

3 Set task to be performed 3 times per week

4 Set task to be performed 4 times per week

5 Set task to be performed 5 times per week

6 Set task to be performed 6 times per week

7 Set task to be performed 7 times per week

If the task is scheduled to run automatically, the next scheduled run time is listed on the
Maintenance Activities screen. Alter the cleaning schedule following the Schedule an
Automated Maintenance Task section as needed (see Schedule an Automated
Maintenance Task on page 193).

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This maintenance task requires the following inventory:

Table 93. Mag Wash Cleaning Inventory
Consumable Minimum Quantity

MTUs 10 Tests

Tips 2 Tips

Waste 20 Tests

Panther Universal Fluid Kit 15 Tests

A or B

Mag Wash 25.5 mL

Cleaning Solution

To perform the Mag Wash Clean maintenance task:

1. Load a new bottle of Mag Wash Cleaning Solution in the cleaning solution slot
according to the Replace Mag Wash Cleaning Solution instructions, if needed (see
Replace Mag Wash Cleaning Solution on page 209).
2. Prior to the time that the task will be performed, ensure that a sufficient inventory of the
required materials will be available when this maintenance task will begin.
3. Initiate the maintenance task via one of the following two (2) methods:
l Schedule a recurring date and time for this maintenance task to be automatically

performed following instructions in the Schedule an Automated Maintenance

Task section (see Schedule an Automated Maintenance Task on page 193).
l Perform this task manually as follows:

a. Ensure that the instrument is in the Setup or Ready state.

b. Select the Mag Wash Clean task on the Maintenance Activities screen.
c. Select Start.
The Run Maintenance Task screen for the Mag Wash Cleaning task opens.
d. Select Start.
The Run Maintenance Task screen for the Mag Wash Cleaning task
updates with an estimated completion time.
e. Once the maintenance task has completed, select Done.

Clean the Sample Shield

Clean the Sample Shield weekly in order to properly maintain a clean environment within
the system. Perform this task when the instrument is in the Setup or Ready states.
Complete the procedure as part of Monthly Maintenance and additionally as needed.

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To clean the Sample Shield:

1. Unload all Sample Racks (see Unloading Sample Racks on page 129) and assay
reagents (see Unloading Panther Assay Reagents on page 112) from the system and
ensure that the system is not in the Assay Processing or Maintenance states.
2. From the Maintenance Activities screen, select Clean Sample Shield.
3. Select Start.
A Run Maintenance Task screen for the Clean Sample Shield task opens.
4. Select Start.
The TCR Carousel stops spinning and the TCR Door unlocks.
5. Open the TCR Door and the Right Canopy Door.
6. Carefully remove the Sample Shield from the Sample Bay by handling the shield by
the tab and the front of the shield.
7. Submerge the Sample Shield in a container filled with either 2.5%–3.5% sodium
hypochlorite solution or prepared Bleach Enhancer solution.
8. Soak the shield for 10 minutes.
9. Rinse the shield thoroughly with running DI or tap water and lay flat or place upright to
dry.
10. Place a decontaminated and dried Sample Shield onto the guide pins.
11. Ensure that the Sample Shield is properly loaded with all three (3) guide pins securely
holding the shield atop the Sample Bay.
12. Close the Right Canopy Door and the TCR Door.
13. Select Next.
The Maintenance Task Completed screen opens.
14. Select Done.

PC Reboot Maintenance
Shut down the computer weekly via the PC Reboot task or manually (see System
Shutdown on page 187) in order to properly maintain processing efficiency. Perform this
task when the instrument is in the Setup or Ready state.
To initiate the PC Reboot Maintenance task:
1. Unload all sample racks (see Unloading Sample Racks on page 129) and assay
reagents (see Unloading Panther Assay Reagents on page 112) from the system and
ensure that the system is not in the Assay Processing or Maintenance states.
2. From the Maintenance Activities screen, select PC Reboot.
3. Select Start.
A Run Maintenance Task screen for the PC Reboot Maintenance task opens.
4. Select Start to shut down and restart the computer.
The computer safely shuts down and restarts.
5. Login to the software as directed in the Login section (see Login on page 92).

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 Maintenance

Monthly Maintenance
Clean the entire Panther System once a month to maintain a clean environment within the
instrument. The procedure takes approximately 45 minutes to complete. Perform this task
when the instrument is in the Setup or Ready state.

Warning—Follow Universal Precautions when handling waste. It may

contain infectious biohazardous waste and sodium hypochlorite.

Caution—Do not spray sodium hypochlorite solution, prepared Bleach

Enhancer solution (if applicable), or water directly on the Panther System
surfaces.

Prior to cleaning any hardware components, unload all samples and reagents from the
instrument. Follow the step-by-step onscreen instructions ensuring that each activity is
completed as instructed. The task will not be recorded as completed unless the entire
procedure is performed. The following instructions augment the onscreen instructions by
providing detailed instructions concerning the type of cleaning solution being used to
perform the maintenance procedure.

Step 1. Clean the Monitor and Scanner

To clean the monitor and scanner:
1. From the Maintenance Activities screen, select the Monthly Maintenance task.
2. Select Start.
A Run Maintenance Task screen for the Monthly Maintenance task opens.
3. Select Start.
4. Wipe the barcode scanner with an alcohol wipe.
5. Wipe the surface of the monitor with an alcohol wipe making sure to not wipe the
Next button.
6. After the monitor has been properly wiped down, clean the Next button. Ensure
that the Next button is selected in order to advance to the next step in the
maintenance procedure.

Step 2. Clean the Tip Drawers

To clean the Tip Drawers:
1. Open the two (2) Tip Drawers (Panther only) following the instructions provided in
the Load Tips section (see Load Tips on page 94).
2. Remove and dispose of all pipette tip trays.
3. Clean the interior and exterior of the drawer railing with a wipe moistened with
2.5%–3.5% sodium hypochlorite solution or prepared Bleach Enhancer solution.

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4. If using 2.5%–3.5% sodium hypochlorite solution, wait one (1) minute and then
clean the surface with a wipe moistened with DI water.
5. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surface.
6. If using prepared Bleach Enhancer solution, repeat steps 3 and 5.
7. Close the Tip Drawers. The Tip Drawers should be empty.
Note—The Tip inventory will be reset to zero at the conclusion of this
task.

8. Select Next to advance to the next step in the maintenance procedure.

Step 3. Clean the Reagent Bay

To clean the Reagent Bay:
1. Open the Reagent Bay Door and the Left Canopy Door.
2. Clean the Reagent Shield and the left side of the Canopy Separator by wiping
down the surfaces with a wipe moistened with either a 2.5%–3.5% sodium
hypochlorite solution or prepared Bleach Enhancer solution.
3. If using 2.5%–3.5% sodium hypochlorite solution, wait one (1) minute and then
clean the surface with a wipe moistened with DI water.
4. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surface.
5. If using prepared Bleach Enhancer solution, repeat steps 2 and 4.
6. Clean the interior of the Reagent Bay and Reagent Bay Door with a wipe
moistened with 2.5%–3.5% sodium hypochlorite solution or prepared Bleach
Enhancer solution.
7. If using 2.5%–3.5% sodium hypochlorite solution, wait one (1) minute and then
clean the surface with a wipe moistened with DI water.
8. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surface.
9. If using prepared Bleach Enhancer solution, repeat steps 6 and 8.
10. When finished drying the interior of the Reagent Bay, ensure that the tabs on the
front and back of the Reagent Shield are resting properly on the pegs on the top
of the Reagent Bay.
11. Close the Left Canopy Door and the Reagent Bay door.
12. Select Next to advance to the next step in the maintenance procedure.

Step 4. Clean the Sample Bay

To clean the Sample Bay:
1. Open the TCR Door, Sample Bay Door, and the Right Canopy Door.
2. Remove the Advanced Cleaning solution (Mag Wash) from the cleaning solution
holder.

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3. Clean the cleaning solution holder with a wipe moistened with 2.5%–3.5%
sodium hypochlorite solution or prepared Bleach Enhancer Solution.
4. Remove the TCR Bottle Adapters, as necessary.
5. Clean the TCR Bottle Adapters with a wipe moistened with 2.5%–3.5% sodium
hypochlorite solution or prepared Bleach Enhancer solution or soak them in a
container of 2.5%–3.5% sodium hypochlorite solution or prepared Bleach
Enhancer solution for 10 minutes. If soaking the adapters, rinse with water after
soaking and let air dry.
6. Clean the TCR Carousel bottle positions with a wipe moistened with 2.5%–3.5%
sodium hypochlorite solution or prepared Bleach Enhancer solution. Rotate the
carousel as necessary to gain access to all bottle positions.
7. If using 2.5%–3.5% sodium hypochlorite solution to wipe down the cleaning
solution holder, the TCR Carousel bottle positions, and the TCR Adapters, wait
one (1) minute and the clean the surfaces with a wipe moistened with DI water.
8. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surface.
9. If wiping down the surfaces with prepared Bleach Enhancer solution, repeat
steps 3, 5, 6, and 8.
10. Place the cleaned TCR Bottle Adapters on a clean surface away from the system.
11. Carefully remove the Sample Shield from the Sample Bay by sliding the shield as
needed and lifting it off the guide pins. Soak the shield in a container of 2.5%–
3.5% sodium hypochlorite solution or prepared Bleach Enhancer solution for 10
minutes.
12. Clean the interior of the Sample Bay, Sample Bay Door, and the right side of the
Canopy Separator with a wipe moistened with 2.5%–3.5% sodium hypochlorite
solution or prepared Bleach Enhancer solution.
13. If using 2.5%–3.5% sodium hypochlorite solution to clean the Sample Bay, wait
one (1) minute and then clean the surface with a wipe moistened with DI water.
14. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surface.
15. If wiping down the surfaces with prepared Bleach Enhancer solution, repeat
steps 12 and 14.
16. Change gloves before continuing.
17. Remove the Sample Shield from the container and rinse thoroughly with running
DI or tap water and lay flat or place upright to dry.
18. Place a decontaminated and dried Sample Shield onto the guide pins.
19. Ensure that the Sample Shield is properly loaded with all three (3) pins securely
holding the shield atop the Sample Bay.
20. Place the cleaned and dry TCR Bottle Adapters in the appropriate positions of
the TCR Carousel.
21. Place the bottle of Advanced Cleaning solution (Mag Wash) back into the
cleaning solution holder.

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22. Close the Right Canopy Door, the TCR Door, and the Sample Bay Door.
23. Select Next to advance to the next step in the maintenance procedure.

Step 5. Clean the Panther Universal Fluid Drawer

Before starting the procedure, obtain a new set of Oil, Auto Detects, Wash Solution,
and Deactivation Buffer bottles if Fluid Kit A or Fluid Kit B has less than 105 tests
remaining.
To clean the Universal Fluid Drawer:
1. Open the Universal Fluid Drawer.
2. Remove and set aside the NaOCl bottle, Oil, Auto Detect, Wash Solution, and
Buffer for Deactivation bottles on a clean surface making sure to group Fluid Kit A
and Fluid Kit B apart so that they can be reloaded into the drawer after cleaning.
3. Inspect the NaOCl bottle and the Universal Fluid drawer for any liquid spills. If
any leaks are found, contact Hologic Technical Support.
4. Clean all fluid connections and caps with a wipe moistened with 2.5%–3.5%
sodium hypochlorite solution or prepared Bleach Enhancer solution.
5. If using 2.5%–3.5% sodium hypochlorite solution, wait one (1) minute and then
clean the surfaces with a wipe moistened with DI water.
6. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surfaces.
7. If using prepared Bleach Enhancer solution, repeat steps 4 and 6.
8. Rinse the vent holes and metal parts with DI water to ensure that the vent holes
on the Auto Detect 2 and Deactivation Buffer bottle caps are not clogged. Clear
any clogged vent holes before continuing.
9. Clean the interior surfaces of the Fluid Drawer with a wipe moistened with 2.5%–
3.5% sodium hypochlorite solution or prepared Bleach Enhancer solution.
10. If using 2.5%–3.5% sodium hypochlorite solution, wait one (1) minute and then
clean the surfaces with a wipe moistened with DI water.
11. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surfaces.
12. If using prepared Bleach Enhancer solution, repeat steps 9 and 11.
13. Open the NaOCl Bottle and dispose of the sodium hypochlorite solution
according to laboratory policies.
14. Add approximately 1 L of DI water into the bottle and re-cap.
15. Cover the quick-connect fitting and vent hole to prevent solution from spilling.
Swirl and invert the container to make sure the water contacts all inner surfaces
of the container.
16. Dispose of the rinse solution according to laboratory policies. Rinse solution
contains low concentration sodium hypochlorite.

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17. Use a wipe moistened with 2.5%–3.5% sodium hypochlorite solution or prepared
Bleach Enhancer solution to thoroughly wipe down the outside of the NaOCl
Bottle. Wipe all parts of the cap, including the bottle and cap threads.
18. If using 2.5%–3.5% sodium hypochlorite solution, wait one (1) minute and then
clean the surface with a wipe moistened with DI water.
19. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surface.
20. If using prepared Bleach Enhancer solution, repeat steps 17 and 19.
21. Rinse the quick connect fitting with DI water. Clear the vent hole, if clogged,
before continuing if necessary.
22. Fill the bottle to the fill line with 5.0%–7.0% sodium hypochlorite solution and re-
cap.
23. Place the cleaned and refilled NaOCl Bottle back in the Universal Fluid Drawer
with the handle pointing towards the center of the drawer.
24. Place the two (2) kits of fluids in the Universal Fluids Drawer according to the
instructions provided in steps 3–16 of the Load Universal Fluids section (see
Load Universal Fluids on page 98). Ensure that the bottles in each fluid set are
grouped together as they had been prior to removal.

Step 6. Clean the Panther Waste Drawer

Before starting the procedure, obtain a new Waste Bag and Waste Cover.
To clean the Panther Waste Drawer:
1. Open the Panther Waste Drawer.
2. Disconnect the Liquid Waste Container and place it on an absorbent pad for later
cleaning. Do not place the Liquid Waste Container in the same area where
assay reagents or specimens are prepared.
3. Dispose of the MTU Waste Bag and MTU Waste Cover according to laboratory
policies.
4. Inspect the drawer for any liquid spills. If any spills are found, contact Hologic
Technical Support.
5. Clean the Waste Drawer and Solid Waste Container surfaces thoroughly with a
wipe moistened with 2.5%–3.5% sodium hypochlorite solution or prepared
Bleach Enhancer solution.
6. If using 2.5%–3.5% sodium hypochlorite solution, wait one (1) minute and then
clean the surface with a wipe moistened with DI water.
7. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surface.
8. If using prepared Bleach Enhancer solution, repeat steps 5 and 7.
9. Fit a new Waste Bag into the Solid Waste Container taking care to perform the
following tasks.
l Press the bag down into the Solid Waste Container, smoothing the sides of

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the bag flat to the sides of the container.

l Fold the top of the bag down around the outside of the Solid Waste
Container.
10. Slide a new Waste Cover over the Waste Bag on the back of the container.
11. Inspect the Liquid Waste Container for cracks and smooth magnet movement. If
cracks are found, contact Hologic Technical Support.
12. Remove the bottle cap from the Liquid Waste Container and slowly pour the
contents of the Liquid Waste Container into the appropriate designated sink or
receptacle. Dispose of the contents according to laboratory policies.
Warning—Tilt the Liquid Waste Container appropriately to ensure that
no waste enters the tubing within the container. Use the holds on the
container to aide in pouring of the contents.

Figure 107. Disposing of Liquid Waste Container Contents (Example)

13. Add approximately 2 L of 2.5%–3.5% sodium hypochlorite solution and then re-
cap the container.
14. Swirl the solution in the container to make sure the sodium hypochlorite solution
contacts the inner surfaces of the container. Do not invert container.
15. Allow the solution to remain in the container for at least 10 minutes and then
remove the cap and dispose of the rinse solution according to laboratory policies.
16. Add approximately 2 L of water and then re-cap the container.

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17. Swirl the solution in the container to make sure the water contacts the inner
surfaces of the container. Do not invert container.
18. Remove the cap and dispose of the rinse solution according to laboratory
policies.
19. Use a wipe moistened with 2.5%–3.5% sodium hypochlorite solution or prepared
Bleach Enhancer solution to thoroughly wipe down the outside of the container.
Wipe all parts of the cap, including the cap and bottle threads.
20. If using 2.5%–3.5% sodium hypochlorite solution, wait one (1) minute and then
clean the surfaces with a wipe moistened with DI water.
21. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surfaces.
22. If using prepared Bleach Enhancer solution, repeat steps 19 and 21.
23. Replace the cap on the container and place the cleaned Liquid Waste Container
back in the Waste Drawer.
24. Close the Panther Waste Drawer.
25. Change gloves before continuing.
26. Select Next to advance to the next step in the maintenance procedure.

Step 7. Clean the External Surfaces

To clean the external surfaces of the instrument:
1. Wipe down all accessible external panels and operator-accessible doors and
handles with 2.5%–3.5% sodium hypochlorite solution or prepared Bleach
Enhancer solution. Take care to target locations that are touched frequently
during instrument handling. Do not wipe down the monitor and barcode scanner.
2. If using 2.5%–3.5% sodium hypochlorite solution, wait one (1) minute and then
clean the surfaces with a wipe moistened with DI water.
3. Dry the surfaces with a clean wipe. Do not allow the cleaning solution to dry on
the surfaces.
4. If using prepared Bleach Enhancer solution, repeat steps 1 and 3.
5. Select Next.
The Maintenance Task Completed screen opens.
6. Select Done.
Note—The Panther Tip Drawers will be empty following the conclusion of
this task. Load six (6) pipette tip trays according to the instructions in the Load
Tips section before next using the system for assay processing (see Load
Tips on page 94).

Replace Mag Wash Cleaning Solution

Replace the Advanced Cleaning Solution after the system generates a message that the
task is overdue. The system automatically tracks the volume of the cleaning solution and

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will provide an update when there is inadequate volume to perform another Mag Wash
Clean. Perform this task when the instrument is in the Setup or Ready states. Do not add
or remove reagents from the TCR Carousel in the process of performing this task.
Replace the Mag Wash Cleaning Solution as follows:
1. Obtain a new bottle of Mag Wash Cleaning Solution.
2. From the Maintenance Activities screen, select the Replace Mag Wash Cleaning
Solution task.
3. Select Start.
A Run Maintenance Task screen for the Replace Mag Wash Cleaning Solution task
opens.
4. Select Start.
The TCR Door unlocks.
5. Open the TCR Door and the Right Canopy Door.
6. Remove the depleted bottle of cleaning solution.
7. Remove the cap and place the new cleaning solution bottle in the cleaning solution
holder.
8. Dispose of the depleted cleaning solution bottle according to laboratory procedures.
9. Close the Right Canopy Door and the TCR Door.
10. Select Next.
The Maintenance Task Completed screen opens.
11. Select Done.

Idle Maintenance
Store the system as appropriate for any idle duration. If the system is to be left powered on
without processing samples, follow the maintenance activities outlined in the table to
prevent fluid line blockages and deterioration of the subsystems.
Table 94. Idle Maintenance Procedures
Expected Idle
Period Procedures

Up to 4 Weeks l Remove Biohazard Waste prior to expected idle periods

l Prime the system at least twice per week
l Continue to perform the Mag Wash Clean procedure as
recommended

Beyond 4 Weeks l Contact Hologic Technical Support for additional

maintenance information.

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Clean Sample Racks and Reagent Racks

Clean Sample Racks and Reagent Racks after each use to minimize contamination.
To clean Sample Racks and Reagents Racks:
1. Submerge the empty rack in an appropriately sized clean container filled with 2.5%–
3.5% sodium hypochlorite solution (see Preparing Sodium Hypochlorite Solution on
page 198) or prepared Bleach Enhancer solution. Wet all surfaces of the rack with the
cleaning solution.
2. Soak the rack in the container for 10 minutes.
Note—Exposure to the cleaning solution of over 10 minutes could
accelerate degradation of the rack and rack labels.

3. Remove the rack from the container and rinse thoroughly with running DI or tap water.
4. Place the rack on a clean absorbent pad, and allow to air-dry thoroughly.

Database Maintenance
Backup the database as desired in order to retain a copy to use after a possible database
corruption. Purge data from the database to enable efficient system operation. Purging of
data can be done either automatically or as part of routine maintenance. Refer to the
Database Administration section (see Database Administration on page 215) for
information on maintaining the size of the database.
Backup and refresh the database during the startup process. Only an Administrator
should perform these tasks (see Adding Operator Accounts on page 240).

Database Backup
Backup the database, as needed, to save an uncorrupted copy of the database on
the computer hard drive. Do not save a copy of the database after a database
corruption event occurs.
To back up the database:
1. Shut down the Panther System (see System Shutdown on page 187).
2. Start up the Panther System (see System Startup on page 92).
The Desktop Shield screen opens.
3. From the Desktop Shield screen, select Backup.
4. Enter the user name and password, if necessary, and select OK.
Note—The system does not require a user name and password if the
database was corrupted.

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The Backup Panther Database screen opens with the default file save
destination.

5. Select the file directory button and choose a new file save destination, if
necessary, and select OK.
6. Select Execute.
A current copy of the database is saved to the file destination. The screen
transitions back to the Desktop Shield screen following completion of the task.
Select Panther to initiate the Panther System Software.

Database Restore
Restore the database to a previously saved version. Do not restore the database
without the guidance of Hologic authorized personnel. Only administrators should
perform this task.
To restore the database:
1. Shut down the Panther System (see System Shutdown on page 187).
2. Start up the Panther System (see System Startup on page 92).
The Desktop Shield screen opens.
3. From the Desktop Shield screen, select Restore.
4. Enter the user name and password, if necessary, and select OK.
Note—The system does not require a user name and password if the
database was corrupted.

The Restore Panther Database screen opens with the default file location.

5. Select the file directory button and choose the database file location, if
necessary, select the desired database file (.bak), and select OK.
6. Select Execute.
The software loads the selected database file upon software initiation. The
screen transitions back to the Desktop Shield screen following completion of the
task. Select Panther to initiate the Panther System Software.

Delete Database
Only perform this task under the guidance of a Hologic representative. This task
provides instructions for deleting saved copies of the database. Only administrators
should perform this task.
To delete the database:
1. Shut down the Panther System (see System Shutdown on page 187).
2. Start up the Panther System (see System Startup on page 92).

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The Desktop Shield screen opens.

3. From the Desktop Shield screen, select Delete Database.
4. Enter the user name and password, if necessary, and select OK.
The Delete Panther Database screen opens.

5. Select the file directory button and choose the database file location, if
necessary, select the desired database file (.bak) to be deleted, and select OK.
6. Select Execute.
The software deletes the selected database file. The screen transitions back to
the Desktop Shield screen following completion of the task. Select Panther to
initiate the Panther System Software.

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System Administration
Configure the system from the Administration screen. Manage the configuration settings
when the instrument is in the Setup or Ready state. Only an Administrator can alter the
configuration settings.

Specimen Processing Modes

Specimens can be tested on the system using one of three (3) different processing
modes:
l Random Access Loading—using bidirectional LIS host query
l Batch Loading—using specimens with SID barcodes

l Batch Loading—using specimens without SID barcodes

If the system is connected to an LIS and the Enable LIS Connection configuration is
enabled, test orders are assigned to samples through the LIS (see LIS Configuration on
page 236).
If the Enable LIS Connection configuration is not enabled, test orders are assigned
based upon the sample default settings in the batch testing mode.

Random Access Loading—Bidirectional LIS Host Query

Random access sample loading allows sample tubes with different assay test orders
to be loaded into a sample rack in any order. If the system is connected to an LIS,
there are two pathways for the system to retrieve the test order information:

Manual Download
The operator selects Fetch From LIS to populate the database with test orders from
the LIS. These test orders are then available for assignment to specimens upon
loading.

Automatic Host Query

Upon sample loading, the system automatically searches the LIS database for the
corresponding test order(s).

In these scenarios, the system associates test orders with loaded specimens that are
recognized by the system through their SID barcodes. A positive match between the
LIS test order and the SID is necessary before specimen processing can proceed.
The test orders are automatically associated with the appropriate SID barcodes upon
sample loading.

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Loaded samples with valid SIDs that do not have a matched test order will not be
processed until either an associated test request is located or a test order is manually
added.

Batch Loading
Specimens can be “batched” together as a group or as a sequence of specimens to
all have the same assay test orders. If the system is not configured to interact with an
LIS, the system automatically associates test orders with specimens based upon the
sample default settings on the Sample Rack screen. Under this testing scenario,
there are two (2) pathways for the system to proceed with assigning a test order to
the corresponding specimens:

Samples with Barcodes

System scans the tubes upon loading and uses the SID barcode to positively track
patient samples from the time they were loaded until the time they receive a result.
Define the sample defaults prior to sample loading according to instructions in the
Setting Sample Defaults section (see Sample Defaults on page 117).

Samples without Barcodes

System can assign Sample IDs (SIDs) to samples without barcodes based upon
configuration settings.
If the Enable Non-Barcode Sample Loading configuration is enabled, samples
without barcodes are assigned SIDs based upon the sample default settings. Set
these sample default settings according to the instructions in the Configuring
Additional Sample Defaults section (see Enable Non-Barcode Sample Loading on
page 224).
If the Enable Auto Sample ID Assignment for Unreadable Barcode configuration
is enabled, samples without barcodes are assigned an auto-generated SID number
based upon rack position. If results verification is required, samples with auto-
generated SIDs need to be corrected before sample results can be verified (see
Enable Non-Barcode Sample Loading on page 224).

Database Administration
From the Data Management screen, configure the system to automatically purge system
logs from the database to better enable efficient system operation. Purging of data can be
done either automatically or as part of routine maintenance. It is recommended that the
system's automatic purge configuration settings for all three (3) log types and the results
are configured for a maximum of 365 days. Purged data is permanently deleted from the
Panther System database.
Purge data when the system is in the Setup or Ready state. Only an Administrator can
perform these tasks (see Adding Operator Accounts on page 240).

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Auto Purge Log Configuration

Purging of Activity logs, Maintenance logs, Message logs, and Results can be done
automatically based upon the duration that the logs have resided in the database.
To configure the logs to purge automatically:
1. From the Administration screen, select Data Management.
A Data Management screen opens.
2. Select one of the following four (4) Auto Purge categories:
l Auto Purge Activity Log Config—To configure the automatic purge

settings for the Activity Logs.

l Auto Purge Maintenance Log Config—To configure the automatic purge

settings for the Maintenance Logs.

l Auto Purge Message Log Config—To configure the automatic purge

settings for the Message Logs.

l Auto Purge Results Config—To configure the automatic purge settings for

results.
The Auto Purge Log Config window of the selected category opens.
3. From the Auto Purge Log Config window, check the cell for Enable Auto Purge
Log Config to configure the system to automatically purge the selected logs
based upon the selected settings.
4. Select the Purge by days older than field.
A number keypad opens.
5. From the keypad, set the number of days to retain the selected log files in the
database before they are purged from the system.
6. Select OK.
The keypad closes.
7. If configuring the Auto Purge Results Config settings, check the cell for Only
purge results if they have been transmitted to LIS to retain results that have
not been transmitted to the site's LIS. If this setting is not desired or the system is
not connected to an LIS, leave this cell unchecked.
8. Select Accept once all settings are configured as desired.
The system purges any logs or results that have been in the system for more
than the number of days entered. Going forward, log files for the selected
category will be removed from the system after the chosen number of days.

Purge Logs
To manually purge logs:
1. From the Administration screen, select Data Management.
The Data Management screen opens.

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2. Select one of the following three (3) Purge Log categories:

l Purge Activity Log—To manually purge Activity Logs.

l Purge Maintenance Log—To manually purge Maintenance Logs.

l Purge Message Log—To manually purge Message Logs.

The Purge Log window of the selected category opens.

3. Select one of the following two (2) date categories in order to set the desired
purge parameters:
l Purge everything before—To purge all logs data before the selected

Entries created on or before date and time.

l Purge everything between—To purge all logs data between the selected

Entries created on or after and Entries created on or before date and

times.
4. Select the date and time calendar icon for the chosen field(s).
5. From the calendar, set the date and times for the appropriate categories and then
select OK.
6. Select Accept.
7. Select Yes to confirm the purge request.
The system purges the logs that fall within the selected date and time interval.

Purge Results
Purging of results can be done manually based upon the selected dates when the results
were generated. Clearing results from the system removes results data from the Results
screen and may allow for more efficient analysis and filtering when using the screen. If the
system is connected to an LIS, it is possible to filter the purge so that only results that
have been successfully transmitted to the LIS will be removed from the database.
To purge results:

1. Ensure that all results data to be purged has been properly stored according to
laboratory policy. Instructions for exporting results data in report or LIS formats can be
found in the appropriate sections of this manual. Purged results will no longer be
accessible through the system following the completion of this procedure.
2. From the Administration screen, select Data Management.
The Data Management screen opens.
3. Select Purge Results.
The Purge Results window opens.

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Figure 108. Purge Results Window (Example)

4. Select one of the following two (2) data categories in order to set the desired purge
parameters:
l Purge everything before—To purge all results before the selected Results

completed on or before date and time.

l Purge everything between—To purge all results between the selected Results

completed after and Results completed on or before dates and times.

5. Select the date and time calendar icon for the chosen field(s).
6. From the calendar, set the dates and times for the appropriate categories and then
select OK.
7. Ensure that the Only purge results if they have been transmitted to LIS cell is
checked or left blank as desired.
8. Select Accept.
9. Select Yes to confirm the purge request.
The system purges the results that fall within the selected date and time interval. If
the Only purge results if they have been transmitted to LIS cell was checked,
only transmitted results are purged.

Configuration
From the System Configuration screen, define the options shown below according to the
instructions provided in the associated sections. After changes have been made, select
Save to retain the new configuration settings. If a restart is required, it will be stated inside
the screen name as Restart Needed.

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l User Interface
l Threshold Management
l Universal Fluid Management
l Priming Management
l Assay Reagent Loading
l Specimen Loading
l Results Management
l Report Management
l Data Export Management
l Security Management
l Power Save Management
l UPS Management
l Printer Management
l LIS Configuration
l Operator Management
l Change Password
l Quality Control Configuration
l Reflex Testing Configuration
l Assay Custom Cutoff Value Configuration

User Interface
Use the options available in the User Interface expansion menu to configure the system
interface as needed.
Select and configure the following options within the menu:

Table 95. User Interface Options

Option Description

Enable Check this cell to enable the automatic log off functionality.
Automatic The system will log off the current operator after the system
logoff has been idle for the chosen number of minutes.
Additional instructions provided below.

Enable Remote Check this cell to enable the Remote Diagnostic system (see
Diagnostics Troubleshooting with PRO360° Software on page 254). The
Remote Diagnostics button is enabled on the Messages
screen when this configuration is chosen. The Send to
Service Support button also becomes enabled in the Send
Logs window when exporting logs files.

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Table 95. User Interface Options (Continued)

Option Description

Non-IVD Assay Check this cell to turn off IVD mode and turn on Non-IVD
Mode mode, which allows the user to run assays that are Non-IVD
(e.g. IUO, PEO). The software must be restarted before the
selected configuration setting is enabled in the software.

Enable Automatic Log Off

To enable automatic logoff:
1. From the expanded User Interface menu on the System Configuration screen, check
the Enable Automatic Log Off cell.
2. Select the Automatic Log Off Inactivity Period (minutes) field.
A keypad window opens.
3. From the keypad window, select the desired inactivity period (between five (5) and 60
minutes) for the system to wait before logging off the current operator.
4. Select OK when finished.

Threshold Management
Use the option available in the Threshold Management expansion menu to configure the
waste settings as needed.
If this threshold is met while in the Setup or Ready states, the system provides notification
and requires acknowledgment before allowing more samples to be loaded. Additional
samples can be loaded until the Waste test count reaches zero (0).
Select and configure the following option within the menu:

Table 96. Threshold Management Options

Option Description

Enable Select this field to set the lower limit alarm threshold (between
Waste 0 to 200) for the Waste inventory. Set the number for the
Threshold remaining tests that will trigger a system alarm. The system
will alert the operator when this threshold has been met. The
software must be restarted before the selected configuration
setting is enabled in the software.

Waste Threshold
To set the Waste Threshold:
1. From the expanded Threshold Management menu on the System Configuration
screen, check the Enable Waste Threshold cell.

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2. Select the Warning During Sample Loading When Remaining Tests Are Below
field.
A keypad window opens.
3. From the keypad window, select the desired waste capacity level that will generate a
system alert.
4. Select OK when finished.
5. Shut down and restart the software by selecting the Instrument Shutdown button on
the Logoff/Shutdown screen when in the Setup or Ready state. Restart the software
from the Desktop Shield by selecting the Panther button.

Universal Fluid Management

Use the option available in the Universal Fluid Management expansion menu to
configure the Panther fluids warning and critical threshold.
Select and configure the following option within the menu:
Table 97. Universal Fluid Management Options
Option Description

Panther Select this field to set the lower limit warning alarm threshold
Fluid Icon (between 0 to 600) for the Panther Universal Fluids inventory.
Color Set the number for the remaining tests that will trigger a
Changes to system alarm. The system will alert the operator by changing
Yellow When the Panther Universal Fluids Icon to yellow when this warning
Remaining threshold has been met. The software must be restarted
Tests Are before the selected configuration setting is enabled in the
Below software.
Additional instructions provided below.

Panther Select this field to set the lower limit critical alarm threshold
Fluid Icon (between 0 to 600) for the Panther Universal Fluids inventory.
Color Set the number for the remaining tests that will trigger a
Changes to system alarm. The system will alert the operator by changing
Red When the Panther Universal Fluids Icon to red when this critical
Remaining threshold has been met. The software must be restarted
Tests Are before the selected configuration setting is enabled in the
Below software.
Additional instructions provided below.

From the expanded Universal Fluid Management menu on the System Configuration
screen, select the desired threshold.
To set the thresholds for Panther universal fluids:

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1. Select the desired field to set the warning (yellow) and/or critical (red) test count
threshold.
A keypad window opens.
2. From the keypad window, select the desired level that will generate a system alert.
3. Select OK when finished.
4. Select Save.
5. Shut down and restart the software by selecting the Instrument Shutdown button on
the Logoff/Shutdown screen when in the Setup or Ready state. Restart the software
from the Desktop Shield by selecting the Panther button.

Priming Management
Use the options available in the Priming Management expansion menu to choose and
schedule automated system priming.
When scheduled, the system will perform a prime if the criteria in the Prime Instrument
section are met (see Prime Criteria on page 105).
Select and configure the following options within the menu:
Table 98. Priming Management Options
Option Description

Enable Check this cell to enable and schedule automated priming.

Automatic
Priming Additional instructions provided below.

Automatic Check this cell to configure the system to perform a prime at the
Priming Time chosen time and on select days of the week.

Enable Automatic Priming

To schedule automated priming:
1. From the expanded Priming Management menu on the System Configuration screen,
check the Enable Automatic Priming cell.
2. Select the Automatic Priming Time field.
An Automatic Priming Time window opens.
3. From the clock on the window, select the desired time for the system to perform a
prime.
4. Select OK when finished.
5. Check the boxes for the days of the week that the automated priming should occur.
If all priming criteria are met at the selected day and time, the system will perform a
prime at this scheduled time until the configuration settings are changed.

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Assay Reagent Loading

Use the option available in the Assay Reagent Loading expansion menu to configure the
assay reagents loading process as needed.
Select and configure the following option within the menu:
Table 99. Assay Reagent Loading Options
Option Description

Default Check this cell and select one of the two (2) options to
Reconstitution configure how the reconstitution date is entered by the
Date Selection operator when loading a new assay reagent kit. The
software must be restarted before the selected configuration
setting is enabled in the software.
Additional instructions provided below.

Default Reconstitution Date Selection

To set the reconstitution date selection default:
1. From the expanded Assay Reagent Loading menu on the System Configuration
screen, select the Default Reconstitution Date Selection field.
The Assay Reagent Loading window opens.

Figure 109. Assay Reagent Loading Window (Example)

2. From the window, select the desired default for the system to use during reagent
loading.
3. Select OK when finished.

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4. Shut down and restart the software by selecting the Instrument Shutdown button on
the Logoff/Shutdown screen when in the Setup or Ready state. Restart the software
from the Desktop Shield by selecting the Panther button.

Specimen Loading
Use the options available in the Specimen Loading expansion menu to configure the
specimen loading settings as needed.
Select and configure the following options within the menu:
Table 100. Specimen Loading Options
Option Description

Enable Non- Check this cell to enable loading of specimens without

Barcode Sample barcodes. When enabled, the system will assign sample
Loading IDs based upon the criteria designated in the sample
defaults settings (see Sample Defaults on page 117). Do
not enable this setting when connected to an LIS or when
running unlabeled EQCs.
Additional information provided below.

Enable Auto Check this cell to enable automatic generation of Sample

Sample ID IDs for samples that are loaded with unreadable barcodes
Assignment for or no barcodes. Do not enable this setting when
Unreadable connected to an LIS or when running unlabeled EQCs.
Barcodes

Enable Detection Check this cell to enable detection of a specimen that has
and Flagging of already been processed.
Repeat Barcodes
Additional information provided below.

Reject All Repeat Check this cell to configure the system to automatically
Test Orders reject a specimen that has already been processed with
the same test order. Operator action is necessary to
override or reassign a test order to a rejected specimen.
Additional information provided below.

Manual Barcode Select this field to adjust the number of times a barcode
Entry Mode needs to be entered manually when resolving barcode
issues (see Resolving Barcode Issues on page 263).
Additional instructions provided below.

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Table 100. Specimen Loading Options (Continued)

Option Description

Require Retainers Check this cell to require retainers for sample racks. Rack
for Sample Racks retainers are mandatory on Sample Racks that contain
samples with pierceable caps, regardless of this setting.

Enable Worklist ID Check this cell to enable the use of worklist ID suffix
Suffix functionality. When enabled, the system will assign
worklist IDs based upon the sample defaults settings (see
Configuring Additional Sample Defaults on page 119).
Additional information provided below.

ISBT128 Barcodes Check this cell to accept specimens labeled with ISBT128
Enabled barcodes.
Additional information provided below regarding barcode
stripping.

Enable Non-Barcode Sample Loading

Do not enable this setting when connected to an LIS or when running unlabeled EQCs.
To remove barcode scanning functionality during sample loading, check the Enable Non-
Barcode Sample Loading configuration. In this scenario, the system automatically
assigns an SID to specimens based upon the sample default settings (see Sample
Defaults on page 117).

Enable Auto Sample ID Assignment

Do not enable this setting when connected to an LIS or when running unlabeled EQCs.
To allow auto-generated SIDs to be assigned to samples with unreadable barcodes,
check the Enable Auto Sample ID Assignment for Unreadable Barcodes
configurations and leave the Enable Non-Barcode Sample Loading configuration
unchecked. In this scenario the system assigns an auto-generated SID to all specimens
with unreadable barcodes using the following naming convention:
AGSIDMMDDRRxxxx*
(*xxxx: counting up consecutively from 1 on each new date)

Enable Detection and Flagging of Repeat Barcodes/Reject All Repeat Test

Orders
Configure the system to alert the operator prior to processing duplicate test orders through
the System Configuration screen. Check the Enable Detection and Flagging of Repeat
Barcodes cell to configure the system to alert the operator when a specimen with a

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duplicate test order is loaded. When this option is enabled, the system will transition to
the Sample Rack Loading screen after a duplicate is loaded. The operator can then
accept or reject the duplicate, or all duplicates, as necessary. Select the Allow All
Repeats button to allow any specimen that has already been processed to be tested as
designated. If the duplicate is rejected, the tube will display in red on the Sample Rack
Bay screen and will not be processed. The operator can remove the specimen tube(s)
after rejection.
To automatically reject all duplicate test orders, check the Reject All Repeat Test Orders
cell. When this option is enabled, the system will transition to the Sample Rack Loading
screen after a duplicate is loaded. In this configuration the operator will not be able to
accept the duplicate. The tube will display in red on the Sample Rack Bay screen and will
not be processed. The operator can then remove the specimen tube(s) from the system.

Manual Barcode Entry Mode

To configure the Manual Barcode Entry Mode setting:
1. From the expanded Specimen Loading menu on the System Configuration screen,
select the Manual Barcode Entry Mode field.
A Specimen Loading window opens.
2. Select the desired entry mode from the list on the Specimen Loading window. The
choices on the table are defined below.
Table 101. Manual Barcode Entry Modes
Option Description

Single Manual entry can be completed with a single entry. The SID entered is
visible to the operator. If the ISBT128 setting is enabled, a check digit
entry is required when using this barcode entry mode.

Double Manual entry can only be completed after the SID has been correctly
Visible entered twice. The SID entered is visible on the screen during both
entries.

Double Manual entry can only be completed after the SID has been correctly
Hidden entered twice. The SID entered is not visible on the screen during both
entries.

3. Select OK when finished.

Enable Worklist ID Suffix

To differentiate samples in a Results Report by a worklist ID suffix, check the Enable
Non-Barcode Sample Loading configuration. In this scenario, the system automatically
groups together samples during loading based upon the sample default settings (see
Configuring Additional Sample Defaults on page 119).

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ISBT128 Barcodes Enabled

Check the Enable Non-Barcode Sample Loading configuration to accept specimens
labeled with ISBT128 symbology. Once the cell has been checked, the Specimen
Loading window opens for the operator to select the barcode stripping mode. Select one
of the following three (3) stripping modes during configuration:
Table 102. ISBT128 Barcodes Stripping Options
Option Description

Include Prefix Include prefix and postfix characters

and Postfix in SID.

Exclude Prefix Exclude the prefix characters from the

Only SID.

Exclude Prefix Exclude both the prefix and postfix

and Postfix characters from the SID.

After selecting the stripping mode, select OK to enable the parameter. When enabled, the
parameter strips the characters as selected to align with the configuration of your host
system.

Results Management
Use the options available in the Results Management expansion menu to configure the
Results Management process as needed.
Select and configure the following options within the menu:

Table 103. Results Management Options

Option Description

Enable Result Check this cell to require verification of test results

Verification before exporting LIS data is allowed.

Enable RLU value Check this cell to enable RLU suppression for non-
suppression for positive results when selecting single-analyte
Aptima Combo 2 screening in the Aptima Combo 2 assay.
Additional instructions provided below.

Set Panther Calibrator Check this cell to adjust the calibrator/control validity
and/or Control period to less than the default.
frequency

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Table 103. Results Management Options (Continued)

Option Description

Panther Calibrator After checking the Set Panther Calibrator and/or

and/or Control Control frequency cell, select this field and enter the
frequency (hours) number of hours in the onscreen keypad to adjust the
calibrator/control validity period. Select a number
between 4 and 48 hours. Calibrator/control sets will
then remain valid for the selected time period.
Additional instructions provided below.

Enable RLU Value Suppression for Aptima Combo 2

This configuration, in combination with selecting a single analyte when creating a test
order (see Adding an Assay to the Sample Defaults on page 117), allows for the
suppression of RLU values when single analyte testing (CT or GC) is selected in the
CT/GC assay selection. Enabling this feature will result in the reporting of the RLUs only
when the selected analyte is positive.
RLU suppression is applied to all associated locations where test results are
documented. A test call is not displayed for the analyte that is not selected.
To configure the system to suppress RLUs in the CT/GC assay:
1. From the expanded Results Management menu on the System Configuration screen,
select the Enable RLU value suppression for Aptima Combo 2 field.
2. Select the desired analyte when creating test orders that use the CT/GC assay. If
loading samples using the sample default settings, follow the instructions in the
Adding an Assay to the Sample Defaults section (see Adding an Assay to the Sample
Defaults on page 117).
3. From the System Configuration screen, select Save.
4. Shut down and restart the software by selecting the Instrument Shutdown button on
the Logoff/Shutdown screen when in the Setup or Ready state. From the Desktop
Shield, restart the software by selecting Panther.

Panther Calibrator and/or Control Frequency

To configure the Panther Calibrator and/or Control frequency setting:
1. From the expanded Results Management menu on the System Configuration screen,
check the cell for Set Panther Calibrator and/or Control frequency.
2. Select the Panther Calibrator and/or Control frequency field.
A window opens.
3. Use the up/down arrows to select the desired validity time (hours) for the Panther
Calibrators and/or Controls.
4. Select OK when finished to close the keypad.

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5. Select Save. A Panther window appears with a message. Select OK.

6. Shut down and restart the software by selecting the Instrument Shutdown button on
the Logoff/Shutdown screen when in the Setup or Ready state. From the Desktop
Shield, restart the software by selecting Panther.

Report Management
Use the options available in the Report Management expansion menu to configure
temperature monitoring in the Maintenance Checklist, the report export directory, and the
site information available on reports.
Select and configure the following options within the menu:
Table 104. Report Management Options
Option Description

Enable Check this cell to enable temperature check reporting on the

Temperature Maintenance Checklist.
Check
Reporting Additional instructions provided below.

Report Export Select this field to adjust the export file destination for all reports.
Directory
Additional instructions provided below.

Default Paper This functionality is not available in this software version. The
Size reports will print appropriately for both "A4" and "Letter" page
sizes.

Site Select these fields to adjust the contents of the report headers with
information for the virtual keyboard. This information is displayed in the header of
reports all reports.

Enable Temperature Check Reporting

Check the Enable Temperature Check Reporting cell within the Report Management
drop-down on the System Configuration screen to configure the system to record
temperature checks. When configured, the system records a temperature check on each
day that processing is initiated. The operator logged in at the time the system transitions
to the Assay Processing state is credited for the temperature check within the Temp
Check column on the Maintenance Checklist.

Report Export Directory

To set the report export directory:
1. From the expanded Report Management menu on the System Configuration screen,
select the Report Export Directory field.

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A Report Export Directory window opens.

2. From the window, select the desired export destination for the system to use when
exporting reports.
3. Select OK when finished.

Data Export Management

Use the Data Export Management expansion menu to configure the delimiter characters
for exported LIS data and the data export directory.
Select and configure the following options within the menu:
Table 105. Data Export Management Options
Option Description

Delimiter character for Select this field to configure the delimiter character
LIS export files used for exported LIS data.
Additional instructions provided below.

Raw Data Export Select this field to adjust the export file destination for
Directory kinetic data and LIS data.
Additional instructions provided below.

Delimiter Character for Export Files

To select the delimiter character to use in exported LIS data:
1. From the expanded Data Export Management menu on the System Configuration
screen, select the Delimiter character for export files field.
A Delimiter character for export files window opens.

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Figure 110. Delimiter Character for Export Files Window

2. From the window, select the delimiter for exported LIS data.
3. Select OK when finished.

Raw Data Export Directory

To set the kinetic and LIS data export directory:
1. From the expanded Data Export Management menu on the System Configuration
screen, select the Raw Data Export field.
A Report Export Directory window opens.
2. From the window, select the desired export destination for the system to use when
exporting raw data and LIS data.
3. Select OK when finished.

Security Management
Use the Security Management expansion menu to configure the password and login
security settings as needed.
Select and configure the following option within the menu:

Table 106. Security Management Options

Option Description

Require new users Check this cell to configure the system to require a user to set
to change a new password at initial logon.
password on initial
logon

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Table 106. Security Management Options (Continued)

Option Description

Password Select this field to adjust how many days the operator
Expiration Period password remains valid on the system (between 0–365
(days) days).

Number of login Select this field to configure the system to disable a user
failures for user account after a specified number of consecutive failed log on
disabling attempts (between 0–10 attempts).

l Panther system passwords should be kept private and not shared with any other user.
l Hologic recommends the use of strong passwords, for example 25!aMa2299.

Cybersecurity and Data Protection

To support data integrity, confidentiality and security, the Panther instrument prevents the
installation and execution of unauthorized software and disallows unauthorized changes
to the system software. The Panther database is also encrypted. In addition to these
protective measures, it is recommended to take the following actions to ensure the
Panther is protected and secure:
l The computer USB ports should only be used in accordance with the instructions
provided with the Panther System. Always ensure the external USB flash drive or
portable storage medium is virus-free and not used on public or home computers.
l If the instrument is connected to a network, Hologic requires a firewall be placed

between the Panther instrument and the network in order to protect against malicious
network threats. Hologic will provide an approved hardware firewall.
l The Panther instrument prevents unauthorized use of the computer CD/DVD. The

CD/DVD is restricted to Field Service Engineer functions.

l Ensure all external storage devices are kept in a secure location and only available to

authorized personnel.
Overall, please keep in mind that all employees are responsible for the integrity,
confidentiality, and availability of the data being processed, transmitted, and stored on the
Panther System. Failure to follow these recommendations could increase the risk of
exposure to a virus, spyware, Trojan or hostile code intrusion. If any of these are
suspected, please contact Hologic Technical Support as soon as possible.

Power Save Management

Manually enter and exit the Power Save state through the Logoff/Shutdown screen or
configure the system to automatically enter or exit the Power Save state based upon user
configurable criteria. It is also possible to exit the Power Save state by loading or
removing a Reagent Rack from the system. Once in the Power Save state, the system
reduces energy consumption by powering off the vacuum and reducing power to modules
not necessary for non-processing states. System LEDs are off when in this state.

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After exiting the Power Save state, it may take up to 33 minutes for the temperatures of all
modules to return to their operating set points. All temperature-monitored modules need to
reach target temperatures before the system can enter the Ready or Assay Processing
states. Enable and adjust the Time to End Power Save Mode setting to eliminate any
start up time associated with adjusting incubator temperatures after exiting the Power
Save state (see Time to End Power Save Mode on page 234).
System activities are limited to the following activities when in the Power Save state:
l Removal of Sample Racks from the Sample Bay
l Activities accessible through the Message screen

l Activities accessible through the Test Order screen

l Activities accessible through the Results screen

l Activities accessible through the Report Menu screen

l LIS communication

l Operator management

l Password management

l Help window accessibility

l Activities accessible through the Logoff/Shutdown screen

Use the Power Save Management expansion menu to configure the power save settings
as needed.
Select and configure the following option within the menu:
Table 107. Power Save Management Options
Option Description

Enable Power Select this field to enable the Power Save functionality.
Save Mode
Additional instructions provided below.

Minutes of Select this field to adjust how many minutes before the
inactivity before system transitions to the Power Save state when in the
entering Power Setup or Ready state (between 5 to 1,000).
Save Mode after
Setup or Ready
State

Auto Exit Power Select this cell to configure the system to transition out of
Save Mode the Power Save state at the chosen time and on select
days of the week. Configuring this setting can eliminate
any start up time associated with adjusting incubator
temperatures after exiting the Power Save state.

Additional instructions provided below in the Time to

End Power Save Mode section.

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Enable Power Save Mode

To configure the system to transition into the Power Save state:
1. From the expanded Power Save Management menu on the System Configuration
screen, select the Enable Power Save Mode field.
The menu expands to show the Minutes of inactivity before entering Power Save
Mode after Setup or Ready state field.
2. Select the desired number of minutes of inactivity before the system transitions into
the Power Save state from the Ready or Setup states.

Time to End Power Save Mode

To configure the system to automatically transition out of the Power Save state at a set
time:
1. From the expanded Power Save Management menu on the System Configuration
screen, select the Time to End Power Save field.
A window opens.
2. From the clock on the window, select the desired time for the system to exit the Power
Save state.
3. Select OK when finished.
4. Check the boxes for the days of the week that the system should automatically
transition out of the Power Save state.
5. From the clock on the window, select the desired time for the system to exit the Power
Save state.
6. Select OK when finished.
7. Check the boxes for the days of the week that the system should automatically
transition out of the Power Save state.
If the system is in the Power Save state at the selected day and time, the system will
transition out of the Power Save state at that time. It may take up to 33 minutes for
system temperatures to lock after exiting the state. All temperature-monitored
modules need to reach target temperatures before the system can enter the Ready or
Assay Processing states.

UPS Management
A UPS can be connected to the Panther System to provide back-up power to the system
for a set period of time during interruption of the main power supply. The UPS also
protects the system from potentially harmful incoming power surges.
When the system is configured with a UPS, manual shut down of the computer is not
required during a power outage. If power loss occurs, the instrument is taken into a safe
state and the computer is powered down after a short delay. If this occurs, manually turn
off the instrument.
Use the UPS Management expansion menu to configure the UPS settings as needed.

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Select and configure the following option within the menu:

Table 108. UPS Management Setting Options
Option Description

Enable UPS Select this cell to enable automatic shutdown of the system
Shutdown following an extended loss of power.

Once the Enable UPS Shutdown setting is enabled, the UPS icon appears in the Status
Panel. The icon can appear in the following two states:
l Icon not flashing—UPS connected
l Icon flashing—UPS connection not detected

The operator can also select the UPS icon for additional status information. Available
status messages include the following:
l No UPS found
l Power Source: AC (Battery Charge x%)
l Power source: Battery (Battery Charge x%)

Printer Management
Use the Printer Management expansion menu to configure the printer settings as
needed. Contact Hologic personnel to assist with networking the printer.
Select and configure the following option within the menu:

Table 109. Printer Settings Options

Option Description

Default Printer Select this field to adjust the name for the printer to be used with
Name the system.
Additional instructions provided below.

Default Printer Name

To select the printer to use with the system:
1. From the expanded Printer Settings menu on the System Configuration screen, select
the Default Printer Name field.
A Default Printer Selection window opens.
2. From the window, select the printer to use with the Panther System.
3. Select OK when finished.

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LIS Configuration
Use the LIS Configuration screen to configure LIS settings. Only an administrator can
alter the LIS configuration settings (see Adding Operator Accounts on page 240). Refer to
the Panther System LIS Host interface Guide for assistance in configuring and
troubleshooting the LIS connection and settings.
Select Save on the LIS Configuration screen after altering LIS configurations. The
following LIS settings can be configured from the LIS Configuration screen (see LIS
Configuration Screen on page 80):
Table 110. LIS Configuration Options
General Settings

l Enable LIS Connections

l Interface Layer

l Instrument ID

l Host ID

l Enable Unidirectional Mode

l Enable Automatic Test Order Query

l Enable Automatic Test Order Query in Compressed

Format

l Enable Host Query Responding

l Enable Result Flag Sending in Compressed Format

l Enable Calibration Result Sending

l Enable Control Result Sending

l Enable External Quality Control Sending

l Enable Automatic Result Sending

l Enable Automatic Result Holding

l Field Delimiter

l Component Delimiter

l Repeat Delimiter

l Escape Delimiter

l Enable Escaping

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Table 110. LIS Configuration Options (Continued)

l Date Template

l Time Template

l LIS Directory

l Log Directory

Serial Settings

l Com Port

l Baud Rate

l Data Bits

l Stop Bits

l Parity

TCP/IP Settings

l IP Address

l Port

Serial and TCP/IP Settings

l Query Timeout in Seconds

l Frame Sending Timeout in Seconds

l Frame NAK Timeout in Seconds

l Busy Timeout in Seconds

l Enable ASTM 1381 Logging

l Enable ASTM 1394 Logging

File Settings

l File Sending Directory

l File Receiving Directory

Enable LIS Connection

Enable LIS connections to allow for test order assignment based upon the LIS
configurations chosen on the LIS Configuration screen. Enabling the LIS connection
disables test order assignment through the sample default settings (see Sample Defaults

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on page 117).
To enable LIS settings configured on the LIS Configuration screen:
1. From the Administration screen, select LIS Configuration.
The LIS Configuration screen opens.
2. From the LIS Configuration screen, check the Enable LIS Connection cell.
The Sample Default settings on the Sample Rack Bay screen are disabled. The
system is now configured to run in a bidirectional LIS host query mode. The system
will now interact with the connected LIS to send and receive test order information, as
defined by the options on the LIS Configuration screen.
3. Select Save after altering the LIS configurations.
4. Select OK to confirm.

Disable the LIS Connection

Disable the LIS connection to allow for test order assignment through the Sample
Defaults settings (see Sample Defaults on page 117).
To disable the LIS connection:
1. From the Administration screen, select LIS Configuration.
The LIS Configuration screen opens.
2. From the LIS Configuration screen, uncheck the Enable LIS Connection cell.
The LIS settings on the LIS Configuration screen are disabled. The system will now
assign test orders during Sample Rack loading as defined by the Sample Default
settings on the Sample Rack Bay screen.
3. Select Save after altering LIS configurations.
4. Select OK to confirm.

Enable Automatic Results Holding

If the system is configured to automatically send results to the LIS upon test completion, it
is possible to configure the system to hold results based upon assay and result criteria.
The results that are held are then able to be confirmed, as necessary, and then manually
exported to the LIS through the Results screen (see Sending Results to LIS on page 158).
To enable automatic result holding:
1. From the Administration screen, select LIS Configuration.
The LIS Configuration screen opens.
2. From the LIS Configuration screen, check the Enable Automatic Result Holding
cell.
The Edit Result Types button appears next to the cell.
3. Select Edit Result Types.
The Select Assay to hold from LIS Automatic Sending window opens.

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4. Select the row of the assay type to be edited and select Result Types.
The Result Type Selection window opens.
5. To add filter criteria, select Add.
6. Select the result type to hold from being automatically sent to the LIS upon test
completion for the assay type selected.
7. If adding additional filter criteria, repeat steps 5 and 6.
8. Select the X next to the result type(s) that no longer need to be held.
9. Select OK when finished editing the result holding criteria for the selected assay type.
10. The Result Type Selection window closes and the Select Assay to hold from LIS
Automatic Sending window displays the updated filter criteria for the assay type
chosen.
11. Repeat steps 4–9 for any additional assay types, as necessary.
12. When finished with updating the filter criteria for all assay types, from the Select Assay
to hold from LIS Automatic Sending window, select OK.
13. From the LIS Configuration screen, select Save after altering LIS configuration.

LIS Messages
To view messages sent to and received from the LIS:
1. From the Task screen, select Perform Maintenance.
The Maintenance Activities screen opens.
2. From the Maintenance Activities screen, select LIS Messages.
The LIS Messages window opens.

Figure 111. LIS Messages Window with ASTM 1394 Selected (Example)

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3. Clear messages from the screen, toggle between message types ASTM 1394 and
ASTM 1381, or manually request for test orders to be sent from the LIS from the LIS
Messages screen (see Manually Download Test Orders on page 121).

Operator Management
Use the Operator Management screen to add and edit operator accounts. Only an
administrator can alter operator accounts.
The following table provides the information displayed for each operator on the Operator
Management screen.
Table 111. Operator Management Options
Data Field Description

Enabled The cell displays current activity status of the operator

account.

Operator The operator's full name.

Name

User Name The operator user name that will appear in the Status
Panel at the bottom of the screen when logged on.

Initials The operator initials that will appear in reports.

Role The level of seniority assigned to the operator account.

Password The date the account’s password is set to expire.

Expires

Enable/Disable Operator Accounts

To enable/disable an operator account:
1. From the Operator Management screen, select the operator account to be altered.
2. Check or clear the check in the Enabled cell to either enable or disable the
operator account.

Adding Operator Accounts

To create a new operator account:
1. From the Operator Management screen, select Add.
An Add Operator window opens.

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Figure 112. Add Operator Window (Example)

2. Select the Operator Name field, enter a name that is between 6–30 characters
long, and select OK.
3. Select the Initials field, enter initials that are between 2–3 characters long, and
select OK. Do not select an initial with spaces.
4. Select the User Name field, enter a user name that is between 6–15 characters
long, and select OK. This is the user name that the operator will use to log onto
the system. Do not select a user name that contains spaces.
5. Select the Password field, enter a password that is between 6–15 characters
long, and select OK. Enter the password twice for confirmation.
6. Select the role to be assigned to this operator account in the Role Panel.
The default operator accounts are assigned rights that allow them to perform
basic system operations (the “Operator” role). Additional rights can be assigned
to an operator account based upon the roles described in the following table.

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Table 112. Operator Roles

Role Rights

Operator Users assigned this role have the ability to perform the
following tasks:
l Consumable loading
l Fluid management
l Waste management
l Maintenance (except database)
l Master lot entry
l Assay reagent loading
l Sample loading
l Results management
l Results transmission
l Results verification
l View configuration settings
l Change of their password
Super Operator Users assigned this role have the ability to perform the
following tasks:
l All Operator rights
l Configuration—LIS setup
l Maintenance—Log purge
Administrator Users assigned this role have the ability to perform the
following tasks:

l All Super Operator rights

l Operator account management
l System configuration
l Schedule/Automate maintenance
l Database maintenance
l Database backup
l Results purge

7. Select Accept.
The system creates and activates the account. The owner of the account is
required to enter a new password two (2) times during the initial login.

Editing Operator Accounts

To edit an existing operator account:

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1. From the Operator Management screen, select the operator account to be altered.
2. Select Edit.
An Edit Operator window opens.

Figure 113. Edit Operator Window (Example)

3. Edit the available fields as needed by following the directions in steps 2–6 in the
Adding Operator Accounts section (see Adding Operator Accounts on page 240).
4. Select Accept.

Deleting Operator Accounts

To delete an existing operator account:
1. From the Operator Management screen, select the operator account to be
deleted.
2. Select Delete.
A confirmation window opens.
3. Select Yes to delete the operator account.

Change Password
Use the Change Password window to alter the password of the operator currently logged
onto the system.
1. From the Administration screen, select the Change Password button.
A Change Password window opens.

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Figure 114. Change Password Window (Example)

2. Select the Old Password field, enter the password of the operator logged onto the
system, and select OK.
3. Select the New Password field, enter a new password between 6–15 characters, and
select OK. Enter the new password twice in this manner.
4. Select Accept.
This password must be used the next time the current operator logs on.

Quality Control Configuration

Update quality control settings through the Quality Control Configuration screen. Both
external quality control (EQC) and manufacturer quality control settings can be configured
through this screen.
Add EQC information into the system prior to loading for recognition later during sample
loading. Use barcoded and/or unlabeled EQCs. EQCs loaded with barcodes will
automatically be assigned test orders according to configured settings. Unlabeled EQCs
can be quickly configured during the sample loading process. If using unlabeled EQCs,
do not use the Auto Sample ID Assignment or the Enable Non-Barcode Sample Loading
features. The settings for these must be unchecked in this scenario (see Specimen
Loading on page 224).
EQCs do not replace controls/calibrators and do not affect assay validity. Quality controls
are not required to be included in any assay run.
Change the manufacturer quality controls mean and standard deviation values listed on
the Levey-Jennings Report to override the calculated values listed as default. Entering
custom mean and standard deviation values changes the mean and standard deviation
settings on the applicable charts within the Levey-Jennings Reports.
Use the Quality Control Configuration screen to add and edit quality controls. Only an
administrator can configure the quality controls settings. The following table provides the
information displayed for each EQC on the Quality Control Configuration screen.

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Table 113. External Quality Control Configuration Options

Data Field Description

Control ID The identification number recognized by the system for the control.

Display The identification that will be displayed on reports for the control.
Name

Assay The assay type(s) that can utilize the control.

Lot The user-defined lot number for the control.

Expiration The user-defined expiration date for the control.

Replicates The number of replicates to be run for the control.

The following table provides the information displayed for each manufacturer quality
control on the Quality Control Configuration screen.

Table 114. Manufacturer's Controls/Calibrators Configuration Options

Data Field Description

Assay The assay type(s) that can utilize the control/calibrator.

Ctrl/Cal The name of the control/calibrator.

Name

Result The target analyte that can utilize the control/calibrator.

Type

Mean The mean value entered for the applicable control/calibrator.

Standard The standard deviation value entered for the applicable

Deviation control/calibrator.

Adding/Editing Quality Controls

Adding External Quality Controls

To create a new EQC:

1. From the External Quality Controls tab on the Quality Control Configuration
screen, select Add.
The Add Quality Control window opens.

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Figure 115. Add Quality Control Window (Example)

2. Select the Control ID field and enter the control identification code by entering
text on the virtual keyboard or by using the handheld barcode scanner. Select OK
or Enter on the virtual keyboard when finished. The identification code must be
four (4) to twenty (20) characters in length. The code does not need to be the
barcode.
3. Select the Display Name field and enter the name of the control to be displayed
on reports by entering the text on the virtual keyboard. Select OK or Enter on the
virtual keyboard when finished. The display name must be one (1) to fifty (50)
characters in length.
4. Select Add.
5. Select the assay(s) to be associated with the EQC from the Assay window by
clicking on the assay name. Select OK when finished.
6. Select the Lot Number field and enter the user-defined lot number for the quality
control by entering the text on the virtual keyboard, if desired. Select OK or Enter
on the virtual keyboard when finished. The lot number must be one (1) to twenty
(20) characters in length.
7. Select the Expiration field and choose the user-defined expiration date for the
quality control by selecting the date from the date selection window, if desired.
Select OK when finished choosing the date.
8. Select Clear to remove the expiration dating, if desired.
9. Select Replicates and update the number of replicates to be tested when the
quality control is used on the keypad, if desired. Select OK on the keypad when
finished. The replicate number must be one (1) to ten (10).
10. Skip to Step 12 to finish adding a new quality control. Continue to Step 11 to add
mean and standard deviation information for the EQC.

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11. Select More to add expected mean and standard deviation information for the
EQC that can be used in conjunction with the Levey-Jennings Report, if desired.
If nothing is entered in this field, the Levey-Jennings Report will calculate the
mean and standard deviation statistics using the data from the selected time
range.
The Add Quality Control screen expands to display the Mean/Std. Dev. panel.
a. Select an assay on the Mean/Std. Dev. panel and then select Edit to update
the EQC information.
b. Select the Mean field and enter the desired mean RLU value for the quality
control on the keypad. Select OK on the keypad when finished. The mean
must be a value of zero (0) to 100,000,000.
c. Select the Standard Deviation field and enter the desired standard
deviation RLU value for the quality control on the keypad. Select OK on the
keypad when finished. The standard deviation must be a value of zero (0) to
100,000,000.
d. Select Clear to remove the mean and/or standard deviation values, if
desired.
e. Select Accept when finished to continue back to the Add Quality Control
window.
12. Select Accept to save the information entered for the new quality control.

Editing Quality Controls

To edit an existing quality control:

1. From the appropriate tab on the Quality Control Configuration screen, select the
quality control to be edited.
2. Select Edit.
The window opens with the categories populated with all information previously
added for the selected quality control.
3. Make the desired changes to any accessible category according to the
instructions found in the Adding External Quality Controls section or the Adding
Manufacturer Control/Calibrator Overrides section, as appropriate (see Adding
External Quality Controls on page 245 or see Adding Manufacturer
Control/Calibrator Overrides on page 249).
4. Select Accept to save the edits made to the quality control.

Copying External Quality Controls

To copy an existing external quality control in order to create a new quality control:
1. From the External Quality Controls tab on the Quality Control Configuration
screen, select the quality control to be copied.
2. Select Copy.

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The Copy Quality Control window opens with only the Display Name category
populated.

Figure 116. Copy Quality Control Window (Example)

3. Edit the categories to create a unique external quality control following the
instructions found in the Adding External Quality Controls section (see Adding
External Quality Controls on page 245).
4. Select Accept to save the edits made to the new external quality control.

Deleting Quality Controls

To delete a quality control:

1. From the appropriate tab on the Quality Control Configuration screen, select the
quality control or manufacturer override to be deleted.
2. Select Delete.
3. Select Yes to confirm the deletion of the selected quality control information.

Loading Unlabeled Quality Controls

When running external quality controls that are not labeled, ensure that no barcodes
are used or that they are not visible through the slots on the Sample Rack during
loading. The operator must categorize the quality control through the Sample
Loading screen during the sample loading process.
To categorize an unlabeled specimen as an EQC during the sample loading
process:
1. Load the EQC into the Sample Bay following the instructions in the Load
Samples section (see Load Samples on page 113). Ensure that the quality
control does not have a recognizable barcode visible through the slots on the
Sample Rack.

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The screen transitions to the Sample Loading screen after loading the Sample
Rack and the Barcode Correction window opens.
2. Do not close the Sample Bay Door. Follow the instructions on the screen entitled,
if EQC is unlabeled:
a. From the Barcodes Correction screen, select OK.
The Barcodes Correction screen closes.
b. Select the message in the Status column for the EQC.
c. Select Assign EQC.
The EQC Selection window opens.
d. Select the EQC Name field.
The External Quality Control Name window opens.
e. Select the desired EQC from the list of available names and then select OK.
The EQC Selection window updates with the chosen EQC information.
f. Select Accept to save the selection made for the EQC.
3. Repeat Step 2 for any additional unlabeled EQCs.
4. Continue with correcting any unreadable specimen barcodes or reflex testing
assignment on the Sample Loading screen, as necessary.
5. Select Accept Rack when finished updating the test configuration for the Sample
Rack.

Selecting Assays During EQC Loading

To select assay type(s) for an EQC that’s configured for multiple assays:
1. Load the EQC into the Sample Bay following the instructions in the Load
Samples section (see Load Samples on page 113).
The screen transitions to the Sample Rack Loading screen.
2. Select the message in the Status column for the EQC.
3. Select the Select EQC Assays button.
The EQC Assay Selection window opens.
4. Select Add.
5. Select the desired assay type(s) from the list.
6. Select OK when completed with assay selection.
7. Select Accept to save the selection made for the EQC.
8. Select Accept Rack when finished updating the test configuration for the Sample
Rack.

Adding Manufacturer Control/Calibrator Overrides

To create a manufacturer control/calibrator override:

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1. From the Manufacturer's Controls/Calibrators tab on the Quality Control

Configuration screen, select Add.
The Add Manufacturer Control/Calibrator Override window opens.

Figure 117. Add Manufacturer Control/Calibrator Override Window (Example)

2. Select the Assay field and select the assay type of the control or calibrator that is
to be updated. Select OK on the selection menu when finished.
3. Select the Ctrl/Cal Name field and select the name of the control or calibrator that
is to be updated. Select OK on the selection menu when finished.
4. Select the desired Result Type and select Edit.
5. Select the Mean field and enter the desired mean value for the control or
calibrator on the keypad. Select OK on the keypad when finished. The mean
must be a value of zero (0) to 100,000,000.
6. Select the Standard Deviation field and enter the desired standard deviation
value for the control or calibrator on the keypad. Select OK on the keypad when
finished. The standard deviation must be a value of zero (0) to 100,000,000.
7. Select the Clear button to remove Mean and Standard Deviation values, if
desired.
8. Select Accept to save the Mean and Standard Deviation values entered for the
chosen manufacturer control or calibrator and return to the Add Manufacturer
Control/Calibrator Override screen.
9. Repeat Steps 4–8 to select Mean and Standard Deviation of additional Result
Types, if applicable.
10. Select Accept to save the override information entered for the chosen
manufacturer control or calibrator and return to the Quality Control Configuration
screen.

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Reflex Testing Configuration

Configure the system to automatically add confirmatory test orders to specimens
designated for additional confirmatory testing. This reflex testing option can be configured
in two (2) ways:
l Automatically apply a reflex assay test order to all specimens if they meet the result
interpretation.
l Users select specimens for potential reflex testing during the Sample Rack loading

process.
Use the Reflex Testing Configuration screen to organize the reflex testing settings. Only
an administrator can configure the reflex testing settings. The following table provides the
information displayed for the configuration settings on the Reflex Testing Configuration
screen. Only uniquely barcoded samples loaded can be loaded if Enable Reflex Testing
is selected, regardless if Enable Flagging of Repeat Barcodes is selected or not. If any
duplicate barcodes are loaded with Enable Reflex Testing selected, only the first loaded
sample will be assigned a test order.
Table 115. Reflex Testing Configuration Options
Data Field Description

Assay The assay type that is used for the initial test.

Result The specific result of the initial assay that will generate the
Interpretation reflex test order.

Reflex Assay The assay type that is used for the reflex test.

Enable Reflex Radio cell indicating that automatic reflex test order assignment
Testing is enabled (if checked).

Select a Rack Radio cell indicating that reflex testing assignment is to be

Load done during specimen loading (if checked). Only available if the
Enable Reflex Testing cell has been checked.

When configured for reflex testing, test orders will be generated for specimens with test
order results that match the testing criteria. These reflex test orders will be stored on the
Test Orders screen until the associated specimens are reloaded onto the system. The
Test Orders button flashes yellow when there are reflex test orders present that require
the user to reload the associated specimen tube. When in the batch loading mode,
specimens reloaded with awaiting reflex test orders will not automatically be assigned a
test order for the initial screening assay, regardless of sample default settings. Systems in
random access loading mode continue to receive any non-reflex test orders via the LIS.
After reflex test order assignment, specimens designated for potential reflex testing can
easily be identified on the Sample Rack Bay screen by the "REFLEX" suffix added to the
Sample ID.

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Configuring Automatic Reflex Test Order Assignment

Configure the system to automatically generate reflex test orders for all specimens
that meet the result interpretation criteria through the Reflex Testing Configuration
screen. Under this configuration, specimens that produce results that match the
criteria designated on the screen are assigned a reflex assay test order. This
configuration works the same in batch loading and random access loading (LIS)
modes.
To configure the system to automatically assign reflex test orders:
1. From the Administration screen, select Reflex Testing Configuration.
The screen transitions to the Reflex Testing Configuration screen.
2. Check the Enable Reflex Testing cell for the desired reflex condition. The
system will only list the reflex options if both the initial and reflex assays are
loaded onto the system.
The Select at Rack Load option becomes available after checking the Enable
Reflex Testing cell. Do not check the Select at Rack Load cell for the
automation reflex setting.
3. Select Save to save the changes to the configuration setting.

Configuring Reflex Test Order Assignment During Rack Load

Configure the system to generate reflex test orders for specimens chosen during the
Sample Rack loading process through the Reflex Testing Configuration screen.
Under this configuration, specimens that are scheduled to be tested with the
configured screening assay are highlighted during the Sample Rack loading
process. Specimens can then be designated by the operator for reflex test order
assignment. When designated, those samples that produce results that match the
reflex criteria are assigned a reflex assay test order (see Designating Reflex Tests
During Sample Rack Loading on page 253).
This configuration is handled differently in batch loading and random access loading
(LIS) modes. In the batch loading mode, the system will automatically transition to the
Sample Rack Loading screen to allow the operator to designate specimens for reflex
testing. In the random access loading mode, specimens that are scheduled to be
tested with the configured screening assay are labeled with an "R" upon loading.
The operator will need to select the rack and then select Rack Details to transition to
the Sample Rack Loading screen for specimen designation (see Designating Reflex
Tests During Sample Rack Loading on page 253).
To configure the system to allow the operator to assign reflex test orders during
Sample Rack loading:
1. From the Administration screen, select Reflex Testing Configuration.
The screen transitions to the Reflex Testing Configuration screen.

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2. Check the Enable Reflex Testing cell for the desired reflex condition. The
system will only list the reflex options if both the initial and reflex assays are
loaded onto the system.
The Select at Rack Load option becomes available after checking the Enable
Reflex Testing cell.
3. Check the Select at Rack Load cell.
4. Select Save to save the changes to the configuration setting.

Designating Reflex Tests During Sample Rack Loading

To designate specimens for reflex testing during Sample Rack loading:
1. Load a Sample Rack containing specimens with test orders of the configured
screening assay (assay type found in the Assay column of the Reflex Testing
Configuration screen). If running in batch loading mode, skip Step 2.
In batch loading mode, the screen transitions to the Sample Rack Loading
screen. In random access mode (LIS), specimens that meet the above criteria
are labeled with an "R." Do not close the Sample Bay Door when designating
reflex tests during loading in batch loading mode.
2. If running in random access mode (LIS), select a rack containing specimens with
the "R" notation and then select Rack Details.
3. From the Sample Rack Loading screen, if designating all specimens for reflex
testing, select Reflex All and skip to Step 9. Otherwise, continue to Step 4.
4. If no specimens are to be designated for reflex testing, select Accept Rack.
Otherwise, continue to Step 6.
5. Select the Reflex Assay field to choose the reflex assay for the specimen of
interest.
The Reflex Assay Selection window opens.
6. Select the assay type(s) as desired.
7. Select OK.
8. Repeat Steps 4–7 for any additional specimens to be designated for reflex
testing.
9. When all desired specimens have been designated for reflex testing, select
Accept Rack.

Assay Custom Cutoff Value Configuration

For additional information, refer to the appropriate Panther System Software Application
Sheet.

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Troubleshooting
The tables and issues referenced in this section detail problems that an operator might
encounter while operating the Panther System. The errors are organized by the tasks
where they would be most likely to appear.
The software might display error messages not listed in these tables. Most error
messages inform the operator of the screen or system component that needs to be
modified in order to fix the problem.

Hologic Technical Support

Troubleshooting Over the Phone
Contact Hologic Technical Support according to the solutions offered in the
troubleshooting tables throughout this volume or when in need of additional
assistance. The support representative will work with the operator so that any
issues can be resolved as quickly as possible. The transfer of report or log files
from the system may be necessary in order to properly troubleshoot the issue.

Troubleshooting with PRO360° Software

Hologic offers a remote support system, PRO360° software, to provide a higher
level of customer support to Panther System customers. PRO360° software
allows authorized Hologic support personnel to view the customer screen in real
time and transfer files remotely over secure servers once the operator initiates
communication with Hologic Technical Support.
The following procedure describes how to enable authorized Hologic support
personnel to access the instrument remotely if PRO360° software has been
enabled on the system in question.
Verify that the firewall has been attached and configured. Refer to
documentation for firewall installation/configuration instructions. Ensure that the
Enable Remote Diagnostics configuration is enabled (see Enable Remote
Diagnostics on page 219).

Initiating a Remote Diagnostics Session

1. Contact Hologic Technical Support (see Appendix D. Support Contact
Information on page 398).
2. Acquire the remote diagnostics session code from a Hologic Technical
Support representative.
Note—The remote diagnostics session code is valid for 15
minutes.

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3. Ensure that the system is not in the Assay Processing state.

4. From the Messages or Desktop Shield screen, select Remote
Diagnostics.
The Remote Diagnostics Management window opens.

Figure 118. Remote Diagnostics Management Window

5. Select Start.
The PRO360° software window opens.

Figure 119. PRO360° Software Window (Example)

6. Open the Computer Door, remove the keyboard and plug the keyboard
USB adapter into an open USB port (located near the connection point
for the monitor arm).
7. Enter the Session Code in the Session Code field.
8. Select Accept.

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Once the dialog box changes from "Connecting" to "Connected,"

Hologic Technical Support personnel have access to the system and
are able to view and control the computer.

Figure 120. PRO360° Software Connection in Progress (Example)

9. Select Accept as needed to allow Hologic personnel to download files
from the system.

Terminating a Remote Diagnostics Session

To manually end a remote diagnostics session:
1. Ensure that Hologic activity has been completed.
2. From the PRO360° window, select Cancel.

Panther System Operator's Manual

Selecting the Help button on the Menu Bar opens the Help window with information
relevant to the current screen. Through this window, it is possible to access all
sections of the Panther System Operator's Manual by using the buttons available on
the menu at the top of the window.

Instrument Information
From the Help window, select About to access the system Instrument Info window. This
window displays the System Software, Instrument Serial Number, and all of the firmware
and Assay Software version information. Refer to this window when providing instrument
information to Hologic personnel.

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Figure 121. Instrument Info Window—Module Information View (Example)

Instrument Info Panel

The system software version, instrument serial number, system start time, and
instrument uptime is located in the Instrument Info panel in the upper left corner of the
About screen which is accessible by selecting the Help button.

Module Information
The Instrument Info window opens showing the Module Information. Scroll through
this screen for the following system information:
l Module firmware versions
l COP firmware version

Assay Versions
From the Instrument Info window, select Assay Versions to access the assay
software information. Refer to this screen for the following assay software
information:
l Assay protocols installed on the system
l Assay protocol software version

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Figure 122. Instrument Info Window—Assay Versions View (Example)

Silence Alarm
The system generates audible alarms to alert the user to important updates of the status
of the instrument. Important system updates are accompanied by an alarm that will
automatically stop after a brief amount of time. Serious system issues that require user
intervention are accompanied by a continuous alarm that can only be stopped by an
operator.
To silence an audible alarm:
1. From the Messages screen, select Silence Alarm.
2. Refer to the system messages on the Messages screen for the cause of the alarm.
3. Attend to system issues as appropriate.

Force MTU Unload

In the event of a system failure, the system can potentially lose the location of MTUs in the
instrument. In order to properly reinitialize the instrument, it is necessary to remove all
MTUs from the system. Only perform an MTU unload if directed by Hologic authorized
personnel.
To initiate a maintenance unload of MTUs from the system:
1. From the Tasks screen, select Perform Maintenance.
The Maintenance Activities screen opens.
2. From the Maintenance Activities screen, select Force MTU Unload.
A confirmation screen opens.

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3. Select Yes to initiate the unload process.

The system performs an MTU unload. The entire process can take up to 60 minutes.

Send Logs
Complete the following procedure for exporting system log files when instructed by
Hologic Technical Support. Do not send logs when the system is in the Assay Processing
state.
1. From the Messages screen, select Send Logs.
A Send Logs window opens.

Figure 123. Send Logs Window (Example)

2. Select the start and end dates as specified by Hologic Technical Support.
3. Check or uncheck file categories as instructed.
4. Select the file directory button, change the export location, and select OK, if
necessary.
A directory opens to allow for changes to the desired file destination.
5. Select Send to Directory.
A confirmation window opens.
6. From the confirmation window, select Yes.

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The system retrieves log files, compresses the files, and exports them to the output
directory. An activity status bar is displayed during this process. When the task is
complete, a confirmation window opens.
7. From the confirmation window, select OK.
The file will appear in the save destination following the naming convention:
PantherLogs_YYYYMMDD_HHMMSS*.gpz
(* The date and time represent the time that the file was created.)

Send Logs Directly to Service Support

Panther System logs can be sent directly to Hologic Technical Support if the system has
remote diagnostic capabilities. Expedite the transmission of logs data by sending the logs
directly to Hologic Technical Support when troubleshooting system issues. Remote
Diagnostics must be functional and the Enable Remote Diagnostics configuration
setting must be enabled through the User Interface menu on the System Configuration
screen to use this functionality.
Complete the following procedure for exporting system log files directly to Hologic
Technical Support when instructed by Hologic Technical Support. Do not send logs when
the system is in the Assay Processing state.
1. From the Messages screen, select Send Logs.
A Send Logs window opens.
2. Select the start and end dates on the Send Logs window as specified by Hologic
Technical Support and select OK for each when done.
3. Select the categories as specified by Hologic Technical Support.
4. Select Send to Service Support.
5. From the confirmation window, select Yes.
The system retrieves log files, compresses the files, and exports them to Hologic
Technical Support. An activity status bar is displayed during this process. When the
task is complete, a confirmation window opens.
6. From the confirmation window, select OK.

Disposing of Contaminated Waste

If an error message is generated that cites the possible presence of contaminated waste
in the waste containers, perform the following tasks.
To dispose of potentially contaminated waste:
1. Perform one of the following tasks:
l Select the appropriate waste icon at the bottom of the screen.

l Select the appropriate Empty Waste button on the Tasks screen.

The Waste Management screen opens.

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2. Select the Unlock Waste Bay button.

Once the Waste Bay is accessible:
1. Slide the Panther Waste Drawer completely open, remove the Liquid Waste Container
from the drawer, and transfer it to the disposal location.
2. Carefully remove the bottle cap from the Liquid Waste Container and add an equal
volume of 5–7% sodium hypochlorite solution to the container.
3. Allow the sodium hypochlorite solution to remain in the Liquid Waste Container for
one (1) hour, and then discard in the dirty sink. Slowly pour the contents of the Liquid
Waste Container into the designated sink or receptacle.
Warning—Tilt the Liquid Waste Container appropriately to ensure no
waste enters the tubing within the container. Use the numerous holds
on the container to aide in pouring of the contents.

Figure 124. Disposing of Liquid Waste Container Contents (Example)

4. Replace the cap on the Liquid Waste Container.
5. Return the Liquid Waste Container to its position in the Waste Drawer and press down
firmly to connect the fittings to ensure a sealed connection.
6. Carefully lift the waste cover off the Solid Waste Container, handling it only by the
sides. Place the waste cover inside the Solid Waste Container.
7. Remove the solid waste from the system and insert the bag into an additional waste
bag.
8. Remove and dispose the waste bag according to laboratory policies.

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9. Fit a new waste bag into the Solid Waste Container, taking care to perform the
following tasks:
l Press the bag down into the Solid Waste Container, smoothing the sides of the

bag flat to the sides of the container.

l Fold the top of the bag down around the outside of the Solid Waste Container.

10. Slide a new waste cover over the waste bag on the back of the container.
11. Perform the following checks to finalize the empty waste procedure:
l Ensure that the waste cover is mounted properly on the back of the Solid Waste

Container.
l Ensure that the Liquid Waste Container is tightly capped and secure in the

drawer.
12. Close the Waste Drawer.

Dropped Tip Inside Sample Tube

If a tip is dropped from the Sample Pipettor into a sample tube, the system software
automatically generates the following message:
Sample pipettor dropped tip in rack lane (X) inside sample tube (Y). Please wait for
the message indicating that it is safe to open the right canopy door.
After a short amount of time [less than five (5) minutes], the following message is
displayed:
Right Canopy door can now be opened. Please refer to help for specific instructions
to safely remove the tip.
Once this message has been generated, follow the directions below in order to safely
restore the affected tube so that the Sample Rack can be removed from the Sample Bay.
To safely handle a tip that has been dropped in the sample tube:
1. Put on fresh gloves.
2. Ensure that the TCR Carousel and the Sample Pipettor are not moving.
3. Open the Right Canopy door.
4. Locate the tip that has been dropped in the sample tube. If unable to locate the tip,
skip to Step 6.
5. In order to prevent cross-contamination of other loaded samples, press the tip down
into the tube as far as possible. It will not be possible to unload the Sample Rack
unless the tip is below the guide rail in the Sample Bay.
6. Close the Right Canopy door.
7. From the Sample Rack Bay screen, select Resume.
Pipetting resumes following a brief period.
8. Once pipetting for the affected rack has concluded, remove the Sample Rack (see
Unloading Sample Racks on page 129), and handle the affected sample according to
laboratory policy.

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9. If the problem persists, contact Hologic Technical Support and provide details of the
event and the status of the sample tube.

Resolving Barcode Issues

When an unreadable barcode error occurs, the user interface will transition to the Sample
Rack Loading screen and instructions on how to resolve the issue will be displayed.

Figure 125. Sample Rack Loading Screen During Barcode Error (Example)

If the sample is an EQC, follow the instructions for an unlabeled EQC (see Loading
Unlabeled Quality Controls on page 248).
When this situation occurs, follow the To correct Patient Sample Unreadable Barcodes
instructions and perform one of the following tasks:
l Remove the Sample Rack, reposition the affected sample tube and reload the rack.
l Remove the Sample Rack and use the handheld barcode scanner to scan the tube
(see Using the Handheld Scanner for Unreadable Barcodes on page 263).
l Use the virtual keyboard to manually enter an SID (see Using the Virtual Keyboard for
Unreadable Barcodes on page 264).

Using the Handheld Scanner for Unreadable Barcodes

To use the handheld barcode scanner to resolve the error:
1. Select OK on the Barcode Correction window.
2. Remove the Sample Rack of the affected specimen tube(s). Do not close the
Sample Bay Door after removing the Sample Rack.

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3. Use the barcode scanner to scan the Tube Position Barcode of the first affected
specimen tube (to the right of the specimen tube).
The Sample ID field on the Sample Rack Loading screen is populated with the
barcode symbol.
4. Use the barcode scanner to scan the barcode of the affected specimen tube.
The Sample ID field is populated with the barcode information.
5. Repeat Steps 3 and 4 for all affected samples. When multiple replicates of single
specimen are affected, editing the sample ID of one test order updates the
sample ID of all test orders.
6. Reload the Sample Rack.
7. Select Accept Rack when finished updating the test configuration for the Sample
Rack, as needed.

Using the Virtual Keyboard for Unreadable Barcodes

To use the virtual keyboard to resolve the error:
1. Select OK on the Barcode Correction window.
2. Remove the Sample Rack of the affected sample tube(s). Do not close the
Sample Bay Door after removing the Sample Rack.
3. From the Sample Rack Loading screen, select the Sample ID field.
The virtual keyboard is displayed.
4. Enter the sample ID and select OK.
Note—Multiple manual specimen barcode entries may be needed
depending upon the configuration of the Manual Barcode Entry Mode
setting (see Manual Barcode Entry Mode on page 224).

5. Repeat Steps 2–4 for all affected samples. When multiple replicates of single
specimen are affected, editing the sample ID of one test order updates the
sample ID of all test orders.
6. Reload the Sample Rack.
7. Select Accept Rack when finished updating the test configuration for the Sample
Rack, as needed.

Unresponsive System Shutdown

In the event of a system failure, the system software may fail to properly transition to an
Error state. When this occurs, the shutdown buttons will not be available to the user.
In order to properly restart the instrument, it is necessary to disengage the instrument from
the computer in order to safely shut down the system.

To shut down the Panther System when unresponsive:

1. Unload all Sample Racks (see Unloading Sample Racks on page 129) and all assay
reagents (see Unloading Panther Assay Reagents on page 112) from the system.

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2. Use the power switch on the rear left of the instrument to turn the instrument hardware
off.
The software recognizes that the computer has been disconnected from the
instrument. Wait until the Instrument Shutdown (Logoff screen) or the Shutdown
(Messages screen) buttons become enabled (approximately 1 minute).
3. From the Logoff screen, select Instrument Shutdown or from the Messages screen,
select Shutdown.
A confirmation window opens.
4. Select Yes to confirm shutdown.
The system software properly shuts down to the Desktop Shield screen.
5. From the Desktop Shield screen, select the shutdown icon.
The computer properly shuts down.
6. To restart the system, follow the System Startup procedure (see System Startup on
page 92).

Replaceable Parts
The instructions in this section contain descriptions of replaceable parts. Always wear
proper protective equipment when replacing Panther System parts.
l Vacuum Trap Filter Replacement
l Universal Fluid Caps Replacement
l Waste Bottle O-rings Replacement

Vacuum Trap Filter Replacement

To replace the Vacuum Trap Filter:
1. Shut down the Panther System (see System Shutdown on page 187).
2. Open the Panther Waste Drawer and locate the Vacuum Trap Filter on the front-right
of the drawer.

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3. Pull on the Vacuum Hose that connects the Vacuum Trap Filter to free the top
connection of the filter.

4. Pull on the Vacuum Trap filter to remove the filter from the Coalescing Bottle.

5. Remove the clear rubber tubing from the bottom of the Vacuum Trap Filter. Insert
rubber tubing on the bottom of the new vacuum trap filter.

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6. Dispose of the used filter according to laboratory procedures.

7. On the new Vacuum Trap Filter, turn the vacuum trap filter knobs clockwise in the
closed position to make sure that the Vacuum Trap Filter is secure.

8. Connect the tubing on the filter to the Coalescing bottle in the drawer.

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9. Connect the Vacuum Tubing to the top of the Vacuum Trap Filter.

10. Close the Panther Waste Drawer.

11. Change gloves.
12. Start up the Panther System and select the Vacuum icon in the Status Panel (see
Status Panel on page 47).
13. Ensure that the vacuum is reading greater than 6 inHg. If the vacuum is reading below
6 inHg, shut down the instrument and ensure the vacuum trap filter connections are
secure once again.
14. If after startup the vacuum readings are still below 6 inHg, call Hologic Technical
Support.

Universal Fluid Caps Replacement

To replace the caps for Panther universal fluid bottles:
1. Ensure that the system is not in the Assay Processing state.
2. Open the Panther Universal Fluids Drawer.
3. Disconnect the quick-connect fitting from the affected fluid bottle cap.
4. Remove the fluid bottle from the drawer and place it on a clean absorbent pad on a
clean work surface.
5. Unscrew the affected cap from the bottle and discard.
6. Screw the new cap onto the bottle.
7. Place the bottle back in its proper location in the Panther Universal Fluids Drawer.
8. Reconnect the appropriate quick-connect fitting to the cap of the fluid bottle.
9. Align the bottle so that the white arrow above the RFID tag is below the arrow on the
drawer liner.
10. Close the Panther Universal Fluids Drawer.

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Waste Bottle O-rings Replacement

This procedure can be performed while the system is powered on. If the system is on,
only perform this procedure while the system is in a state that allows access to the Waste
Drawer.
1. Open the Panther Waste Drawer. If performing this procedure while the system is
powered on, select Unlock Waste Bay to unlock the Waste Drawer through the
Panther Waste Management screen.
2. Disconnect the Liquid Waste Container and place it on an absorbent pad. Do not
place the Liquid Waste Container in the same area where assay reagents or
specimens are prepared.
3. Remove the black O-rings from the male connectors for the Liquid Waste Container.

4. Clean the connectors with a wipe moistened with 2.5%–3.5% sodium hypochlorite
solution.
5. Wait one (1) minute and then clean the connectors with a wipe moistened with DI
water.
6. Place new O-rings on the male connectors.
7. Change gloves.
8. Apply a small amount of Dow Corning High Vacuum Grease to two fingertips.

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Note—Use only Dow Corning High Vacuum Grease.

9. Apply the grease to the two male connectors for the Liquid Waste Container. Ensure
the grease is applied to the entire surface of the O-rings.

10. Apply a small amount of Dow Corning High Vacuum Grease to two fingertips.
11. Apply the grease to the inside of the Liquid Waste Bottle fittings.

12. Change gloves.

13. Place the Liquid Waste Container back in the Waste Drawer.
14. Close the Waste Drawer.

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 Appendix A. Panther System Operation Checklist

Appendix A. Panther System Operation Checklist

Instrument & Laboratory Check 7. Load Assay Reagents
l Check room humidity (20%–85%) l Gently invert reagents, remove caps, ensure no
bubbles and/or precipitate is present
l Check room temperature (15°C–30°C)
l Ensure bottles are properly seated
l Perform external inspection
l Verify all barcodes are visible
l Check for leaks
l Load onto the Panther System
Prepare Workspace
l Ensure wTCR position matches assay reagent lane for
l Clean work areas corresponding reagents
Change Gloves 8. Load Samples
Prepare Assay Reagents l Ensure sample default settings are accurate or test
l Print Assay Reagents Report, if necessary orders are available via LIS
l Reconstitute reagents, if necessary l Rack calibrators and/or controls for each assay reagent
kit loaded, if necessary
l If using previously reconstituted reagents, bring reagents to
room temperature and gently invert all reagents l Confirm correct sample collection and volume
l Warm Probe Reagent, if necessary, and invert l Place samples into racks
Change Gloves l Verify all barcodes are visible
Complete Panther System Tasks l If required, ensure sample retainers are seated
1. Load Tips l Load racks onto the Panther System
2. Load MTUs Change Gloves
Check for: Pipetting & Assay Processing
l All 5 tiplets present l Sample tube graphic will change from:
l All tube positions are free of debris l Green—Sample loaded
l Barcodes present, properly aligned, and undamaged l Yellow—Pipetting in-process
l Distributor foot is undamaged l Blue—Pipetting complete
3. Load Universal Fluids Feed & Monitor
l Replace depleted fluids l Return, as needed, to load tips, MTUs, additional sample
l Ensure all fittings are secure racks, and Assay Reagents
4. Empty Waste Change Gloves

l Ensure all fittings are secure

Review/Manage Results
l Send to LIS, if necessary
Change Gloves
5. Perform Maintenance l Print Results Report, if necessary

l Complete all required maintenance tasks Unload Assay Reagents (optional)

6. Prime l Cap and appropriately store assay reagents.

l Ensure resources are available Log Off (optional)

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 Appendix B. Processing Flags

Appendix B. Processing Flags

The tables in this appendix contain descriptions of the codes that can appear on the
results if an error occurs during assay or results processing.

Assay Processing Flags

Table 116. Assay Processing Flags
Code Description Outcome
APV The internal Assay Sample is invalid. Review must invalidate the
Processes Verifier result.
detected a problem with
the assay process. Review additional assay processing codes to
determine error source. Check all fluid
connections. Contact Hologic Technical
Support.

ARR Assay Reagent Sample is invalid.

pipetting operation
aborted. Reagent rack currently pipetted was
removed/ Reagent pipettor operation aborted.
Sample must be retested.

CFM User defined leading Sample is invalid.

control set failed due to
a hardware error. Contact Hologic Technical Support.

CL1 Calibrator invalidated Calibrator is invalid.

due to failure of worklist
calibrator set. Address the cause of failure for invalid
calibrators in the worklist. Contact Hologic
Technical Support.

CLT A clot was detected in Sample is not tested. Sample results marked
the sample tube during as Invalid.
aspiration.
Sample must be retested. Contact Hologic
Technical Support.

CPF Cap piercing failure, Sample is not tested. Sample results marked
which may be due to a as Invalid.
hardware or penetrable
cap problem. Examine the cap for defects. Contact Hologic
Technical Support.

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
DIL1 Preconfigured dilution 1 Informational message only. No action
used for final necessary.
concentration.

DIL2 Preconfigured dilution 2 Informational message only. No action

used for final necessary.
concentration.

DIL3 Preconfigured dilution 3 Informational message only. No action

used for final necessary.
concentration.

DIL4 Preconfigured dilution 4 Informational message only. No action

used for final necessary.
concentration.

DSP Sample pipetting delay Sample not tested.

error.
Load sample again to reschedule for testing.

DUO The replicate was tested Informational message only. No action

using an assay installed necessary.
as Development Use
Only.

EQC Sample is an External Informational message only. No action

Quality Control necessary.

FDF1 Oil pump dispense Sample is invalid.

failure, which may be
due to a hardware or Check all Oil connections. Contact Hologic
fluid connection Technical Support.
problem.

FDF2 Wash solution pump Sample is invalid.

dispense failure, which
may be due to a Contact Hologic Technical Support.
hardware or fluid
connection problem.

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
FDF3 Auto Detect 1 pump Sample is invalid.
dispense failure, which
may be due to a Check all Auto Detect 1 connections. Contact
hardware or fluid Hologic Technical Support.
connection problem.

FDF4 Auto Detect 2 pump Sample is invalid.

dispense failure, which
may be due to a Check all Auto Detect 2 connections. Contact
hardware or fluid Hologic Technical Support.
connection problem.

FL1 Fluorometer internal MTU is invalid.

error.
Contact Hologic Technical Support.

FL3 Fluorometer internal MTU is invalid.

error.
Contact Hologic Technical Support.

FLSOR Fluorometer signal out MTU is invalid.

of range.
Contact Hologic Technical Support.

FW# Firmware error detected. Contact Hologic Technical Support.

A number with a
corresponding device
will follow the flag.

HB High background Sample is invalid.

reading in the
luminometer prior to Contact Hologic Technical Support.
Auto Detect dispense,
which may be due to a
hardware or reagent
preparation problem.

IDF Incubator door failure. Contact Hologic Technical Support.

IFF (1-3) Incubator 1-3 fan failure. Contact Hologic Technical Support.

IHF (1-3) Incubator 1-3 heater-foil Contact Hologic Technical Support.

failure.

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
IT (1-3) Incubator 1-3 Contact Hologic Technical Support.
temperature was out of
range.

ITF (1-3) Incubator 1-3 dual Contact Hologic Technical Support.

thermistors have
exceeded allowable
range.

IUO The worklist was Informational message only. No action

performed with an assay necessary.
that is for Investigational
Use Only and is not
FDA cleared for IVD
use.

LDF The MTU was not read MTU is invalid.

by the luminometer
because of a delay, Contact Hologic Technical Support.
which may be due to a
hardware or software
problem.

LDT The worklist was Informational message only. No action

performed with an assay necessary.
that was installed as a
lab developed test and
is not FDA cleared for
IVD use.

LPF Luminometer Contact Hologic Technical Support.

positioning failure.

LSF Load Station heater foil Contact Hologic Technical Support.

failure.

LWF Liquid Waste Container Contact Hologic Technical Support.

full.

M The Sample barcode ID Informational message only. No action

was entered by necessary.
keyboard (not scanned).

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
MFM Magnet of the Magnetic MTU is invalid.
Wash Station cannot be
positioned. Contact Hologic Technical Support.

MHF MTU aspiration failure. Sample is invalid.

Contact Hologic Technical Support.

ML1 The Magnetic Wash Sample is invalid.

Station reported the
presence of fluid at the Contact Hologic Technical Support.
residual position after
aspiration.

ML2 The Magnetic Wash Sample is invalid.

Station reported a liquid
level sense too high Run the Mag Wash Clean Procedure.
after Wash dispense. Samples must be retested. Contact Hologic
Technical Support.

ML3 The Magnetic Wash Sample is invalid.

Station reported a liquid
level sense too low after Check Wash connections. Contact Hologic
Wash dispense. Technical Support.

ML5 The Magnetic Wash Sample is invalid.

Station reported a liquid
level sense too high Run the Mag Wash Clean Procedure.
after final aspiration. Samples must be retested. Contact Hologic
Technical Support.

MMF Mag Wash Mixer MTU is invalid.

movement failure
Contact Hologic Technical Support.

MT1 One or more tiplets were MTU is invalid.

not detected on the
Magnetic Wash Station Samples must be retested. Contact Hologic
aspirators at the start of Technical Support if the problem is chronic.
the wash cycle. This Ensure there are tiplets present in MTUs
may be due to a before loading.
hardware problem or
defective MTU.

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
MT2 One or more tiplets were MTU is invalid.
not detected on the
Magnetic Wash Station Contact Hologic Technical Support.
aspirators after the wash
cycle was complete.
This may be due to a
hardware problem.

MOS Mag Wash station taken Run the Mag Wash Clean Procedure.
out of service. Contact Hologic Technical Support.

NTI The sample was not Sample is invalid.

tested due to a
hardware error. Contact Hologic Technical Support.

NTP No pipettor tips Reload pipettor tips.

available.
Contact Hologic Technical Support if pipettor
tips are still available in the Tip Drawers
when this flag was generated.

PCL1 Process control failure Sample is invalid.

for Auto Detect 1.
Contact Hologic Technical Support.

PCL2 Process control failure Sample is invalid.

for Auto Detect 2.
Contact Hologic Technical Support.

PEO The replicate was tested Informational message only. No action

using an assay installed necessary.
as Performance
Evaluation Only.

PFR Pump failure during Sample is invalid.

reagent pipetting.
Contact Hologic Technical Support.

PFS A pump failure occurred Sample is not tested. Sample results marked
during sample pipetting. as Error.
Contact Hologic Technical Support.

PFT A pump failure occurred If possible, system will retry to pipette TCR
during TCR pipetting. into MTU. If there is a hardware failure,
contact Hologic Technical Support.

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
PMFR Pipettor movement Sample is invalid.
failure during reagent
pipetting. Contact Hologic Technical Support.

PMFS Pipettor movement If possible, system will retry to pipette TCR

failure during specimen into MTU. If there is a hardware failure,
pipetting. contact Hologic Technical Support.

PMFT Pipettor movement If possible, system will retry to pipette TCR

failure during TCR into MTU. If there is a hardware failure,
pipetting. contact Hologic Technical Support.

PTF Failure to pick a tip. Sample is invalid.

Sample must be retested. Contact Hologic
Technical Support if problem is chronic.

QNS Sample quantity not Sample is not tested.

sufficient for processing.
Sample must be retested, or re-collected if
volume is too low.
Check all samples for adequate volume prior
to loading.

RBEA Amplification reagent Assay reagent kit is invalid due to low volume
bottle empty. in specified reagent bottle. Any tests in
process with this kit are invalid. Retest
invalidated samples with a new kit. Load a
new kit to test additional samples.

RBEE Enzyme reagent bottle Assay reagent kit is invalid due to low volume
empty. in specified reagent bottle. Any tests in
process with this kit are invalid. Retest
invalidated samples with a new kit. Load a
new kit to test additional samples.

RBEP Probe reagent bottle Assay reagent kit is invalid due to low volume
empty. in specified reagent bottle. Any tests in
process with this kit are invalid. Retest
invalidated samples with a new kit. Load a
new kit to test additional samples.

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
RBEPM Promoter reagent bottle Assay reagent kit is invalid due to low volume
empty. in specified reagent bottle. Any tests in
process with this kit are invalid. Retest
invalidated samples with a new kit. Load a
new kit to test additional samples.

RBESL Selection reagent bottle Assay reagent kit is invalid due to low volume
empty. in specified reagent bottle. Any tests in
process with this kit are invalid. Retest
invalidated samples with a new kit. Load a
new kit to test additional samples

RBET TCR reagent bottle Assay reagent kit is invalid due to low volume
empty. in specified reagent bottle. Any tests in
process with this kit are invalid. Retest
invalidated samples with a new kit. Load a
new kit to test additional samples.

RBETR TER reagent bottle Assay reagent kit is invalid due to low volume
empty. in specified reagent bottle. Any tests in
process with this kit are invalid. Retest
invalidated samples with a new kit. Load a
new kit to test additional samples.

RDFA RDV indicated a failure MTU is invalid.

during dispense of
Amplification reagent. Contact Hologic Technical Support.

RDFE RDV indicated a failure MTU is invalid.

during dispense of
Enzyme reagent. Contact Hologic Technical Support.

RDFP RDV indicated a failure MTU is invalid.

during dispense of
Probe reagent. Contact Hologic Technical Support.

RDFPM RDV indicated a failure MTU is invalid.

during dispensing of
Promoter reagent. Contact Hologic Technical Support.

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
RDFS Sample dispense Sample is not tested. Sample results marked
verification failed. Once as Invalid.
flagged with an RDFS
error, the sample is not Ensure that there are no interfering
processed further. substances and adequate volume in the
sample tube. Sample must be retested, or
recollected if volume is low.

RDFSE Sample eluate dispense Sample is not tested. Sample results marked
verification fails. as Invalid. Retest invalidated sample.

RDFSL RDV indicated a failure MTU is invalid.

during dispense of
Selection reagent. Contact Hologic Technical Support.

RDFT Reagent dispense If possible, system will retry to pipette TCR

failure during dispense into MTU. If there is a hardware failure,
of TCR reagent. contact Hologic Technical Support.

RDFTR Reagent dispense MTU is invalid.

failure during dispense
of TER reagent. Contact Hologic Technical Support.

RT Duplicate Sample ID. Informational Message only. No action

necessary.

RTL Reagent pipettor tip MTU is invalid.

loss.
Contact Hologic Technical Support.

RUO The replicate was tested Informational Message only. No action

using an assay installed necessary.
as Research Use Only.

RVHA Amplification reagent Ensure that reagent bottles are seated

bottle above the properly.
expected volume.
Check Amplification reagent bottle for correct
volume. Contact Hologic Technical Support.

RVHE Enzyme reagent bottle Ensure that reagent bottles are seated
above the expected properly.
volume.
Check Enzyme reagent bottle for correct
volume. Contact Hologic Technical Support.

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
RVHP Probe reagent bottle Ensure that reagent bottles are seated
above the expected properly.
volume.
Check Probe reagent bottle for correct
volume. Contact Hologic Technical Support.

RVHPM Promoter reagent bottle Ensure that reagent bottles are seated
above the expected properly.
volume.
Check Promoter reagent bottle for correct
volume.
Contact Hologic Technical Support.

RVHSL Selection reagent bottle Ensure that reagent bottles are seated
above the expected properly.
volume.
Check Selection reagent bottle for correct
volume. Contact Hologic Technical Support.

RVHT TCR reagent bottle Ensure that reagent bottles are seated
above the expected properly.
volume.
Check TCR reagent bottle for correct volume.
Contact Hologic Technical Support.

RVHTR TER reagent bottle Ensure that reagent bottles are seated
above the expected properly.
volume.
Check TER reagent bottle for correct volume.
Contact Hologic Technical Support.

S The Sample barcode ID Informational Message only. No action

was entered by the necessary.
operator, using the
handheld scanner.

SID An auto-generated Informational Message only. Correct the SID

specimen ID was by following the instructions in the Editing
automatically assigned Auto-Generated Sample IDs section.
by the System due to an
unreadable barcode.

SRR Sample pipetting Sample is invalid.

operation aborted.
Contact Hologic Technical Support.

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 Appendix B. Processing Flags

Table 116. Assay Processing Flags (Continued)

Code Description Outcome
SRRE Sample rack currently Sample is invalid.
being pipetted has been
removed. Contact Hologic Technical Support.

STL Sample Pipettor Tip Sample is invalid.

Loss.
Contact Hologic Technical Support.

SW Kinetic data collection Sample is invalid.

failed or database fails a
test order integrity Contact Hologic Technical Support.
check.

TC The Chiller temperature MTU is invalid.

was out of range while
processing an MTU. Contact Hologic Technical Support.

UMTU An unexpected MTU MTU is invalid.

has been placed in the
luminometer.An Contact Hologic Technical Support.
unexpected MTU has
been placed in the
luminometer or
fluorometer.

URM2 The MTU barcode was MTU is invalid.

unreadable prior to
entering the Contact Hologic Technical Support.
luminometer.The MTU
barcode was
unreadable prior to
entering the
luminometer or
fluorometer.

VACF Vacuum system failure. Worklist or bracket is invalid.

Contact Hologic Technical Support.

VVFS The volume verification Sample results marked as Invalid.

check for TCR + sample
is either too low or too Sample must be retested, or re-collected if
high. volume is too low.
Check all samples for adequate volume prior
to loading.

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 Appendix B. Processing Flags

Results Processing Flags

Table 117. Results Processing Flags
Code Description Outcome
a Invalid kinetic profile. Sample is invalid.
The result calculation
for the flasher analyte Check all fluid connections. Contact Hologic
curve fit has failed. Technical Support.

af Invalid kinetic profile. Sample is invalid.

The post-kinetic
adjustment value for the Check all fluid connections. Contact Hologic
flasher analyte is out of Technical Support.
range.

afc The post-kinetic Sample is invalid.

adjustment value for the
flasher is greater than Check all fluid connections. Contact Hologic
the maximum cutoff Technical Support.
value for the assay.

ag Invalid kinetic profile. Sample is invalid.

The post-kinetic
adjustment value for the Check all fluid connections. Contact Hologic
glower analyte RLU is Technical Support.
out of range for the
calibrator or control.

agc The post-kinetic Sample is invalid.

adjustment value for the
glower analyte is Check all fluid connections. Contact Hologic
greater than the Technical Support.
maximum cutoff value
for the assay.

arl Invalid kinetic profile. Sample is invalid.

The flasher curve R
squared value is less Check all fluid connections. Contact Hologic
than the minimum cutoff Technical Support.
value for the assay.

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 Appendix B. Processing Flags

Table 117. Results Processing Flags (Continued)

Code Description Outcome
ash Invalid kinetic profile. Sample is invalid.
The slope value for the
flasher analyte curve is Check all fluid connections. Contact Hologic
greater than the Technical Support.
maximum cutoff for the
assay.

asl Invalid kinetic profile. Sample is invalid.

The slope value for the
glower analyte is less Check all fluid connections. Contact Hologic
than the minimum cutoff Technical Support.
for the assay.

b Invalid kinetic profile. Sample is invalid.

The curve shape for the
glower analyte is Check all fluid connections. Contact Hologic
Technical Support.
invalid.

bcin Invalid fluorescent curve Sample is invalid.

profile. Control value
falls outside specified Check all fluid connections. Contact Hologic
limits. Technical Support.

brl Invalid kinetic profile. Sample is invalid.

The glower analyte
curve R squared value Check all fluid connections. Contact Hologic
is less than the Technical Support.
minimum cutoff value for
the assay.

bsh Invalid kinetic profile. Sample is invalid.

The slope value for the
glower analyte curve is Check all fluid connections. Contact Hologic
greater than the Technical Support.
maximum cutoff value
for the assay.

bsl Invalid kinetic profile. Sample is invalid.

The slope for the glower
analyte curve is less Check all fluid connections. Contact Hologic
than the minimum cutoff Technical Support.
value for the assay.

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 Appendix B. Processing Flags

Table 117. Results Processing Flags (Continued)

Code Description Outcome
ch The control total RLU is Control and associated samples are invalid.
greater than the
maximum cutoff value. Check all fluid connections. Contact Hologic
Technical Support.

ci Invalid kinetic profile for Sample is invalid.

the control.
Check all fluid connections. Contact Hologic
Technical Support.

cl The control RLU value Control and associated samples are invalid.
is less than the
minimum cutoff for the Check all fluid connections. Contact Hologic
assay. Technical Support.

cv The software has Sample is invalid.

reported a results
Contact Hologic Technical Support.
interpretation error.

e The software has Sample is invalid.

reported a results
processing error. Check all fluid connections. Contact Hologic
Technical Support.

f All samples in the Samples are invalid.

worklist are invalid, may
be due to multiple Check all fluid connections. Contact Hologic
calibrator errors or Technical Support.
multiple invalid kinetic
profiles.

fa The average flasher Calibrator replicate is invalid.

RLU value for a
calibrator is out of Check all fluid connections. Contact Hologic
range. Technical Support.

fb Invalid kinetic profile. Sample is invalid.

The front-to-back ratio is
out of range for the Check all fluid connections. Contact Hologic
assay. Technical Support.

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 Appendix B. Processing Flags

Table 117. Results Processing Flags (Continued)

Code Description Outcome
fe Invalid or indeterminate Retest sample as an Equivocal according to
kinetic profile. The package insert instructions.
glower analyte result is
positive but the flasher
analyte result is
equivocal.

fge Invalid or indeterminate Retest sample as an Equivocal according to

kinetic profile. Both the package insert instructions.
glower analyte and
flasher analyte have
results that are
equivocal.

fl The software has Sample is invalid.

reported a results
Contact Hologic Technical Support.
interpretation error.

g The calibrator glower Calibrator replicate is invalid.

analyte curve is out of
range for the assay. Check all fluid connections. Contact Hologic
Technical Support.

ga The calibrator glower Calibrator replicate is invalid.

RLU average is out of
range. Check all fluid connections. Contact Hologic
Technical Support.

ge Invalid or indeterminate Retest sample as an Equivocal according to

kinetic profile. The package insert instructions.
flasher analyte result is
positive but the glower
analyte is equivocal.

ic Invalid kinetic profile for Sample is invalid.

a specimen.
Check all fluid connections. Contact Hologic
Technical Support.

m Invalid kinetic profile for Sample is invalid.

a specimen. The total
specimen RLU value Check all fluid connections. Contact Hologic
has reached the Technical Support.
maximum for the assay
too early.

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 Appendix B. Processing Flags

Table 117. Results Processing Flags (Continued)

Code Description Outcome
n Invalid kinetic profile for Sample is invalid.
a specimen. The total
specimen RLU value is Check all fluid connections. Contact Hologic
less than the minimum Technical Support.
cutoff for the assay.

p The software has Sample is invalid.

reported an assay
processing error. See additional results processing codes and
assay processing codes for more information.
Contact Hologic Technical Support.

pn Invalid kinetic profile for Calibrator replicate is invalid.

the negative calibrator.
The peak RLU value Check all fluid connections. Contact Hologic
has been reached either Technical Support.
too early or too late.

pp Invalid kinetic profile for Calibrator replicate is invalid.

the positive calibrator.
The peak RLU value Check all fluid connections. Contact Hologic
has been reached either Technical Support.
too early or too late.

r The total RLU value is Sample is invalid.

greater than the
maximum cutoff value Check all fluid connections. Contact Hologic
for the assay. Technical Support.

rm Invalid fluorescent curve Sample is invalid.

profile. Fluorescence
range falls outside Check all fluid connections. Contact Hologic
specified limits. Technical Support.

rtf Invalid fluorescent curve Sample is invalid.

profile. Fluorescence
range falls outside Check all fluid connections. Contact Hologic
specified limits. Technical Support.

rwb Invalid fluorescent curve Sample is invalid.

profile. Internal control
curve emergence falls Check all fluid connections. Contact Hologic
outside specified limits. Technical Support.

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 Appendix B. Processing Flags

Table 117. Results Processing Flags (Continued)

Code Description Outcome
sl Invalid kinetic profile. Sample is invalid.
The slope of the kinetic
curve is out of range for Check all fluid connections. Contact Hologic
the assay. Technical Support.

sp Invalid kinetic profile. A Sample is invalid.

spike was detected in
the kinetic profile. Check all fluid connections. Contact Hologic
Technical Support.

t Invalid fluorescent curve Sample is invalid.

profile. Assay
processing error. Sample must be retested.
Check all fluid connections. Contact Hologic
Technical Support.

ta The software has Sample is invalid.

reported an error in the
kinetic algorithm Contact Hologic Technical Support.
calculation.

ts The software has Sample is invalid.

reported that a kinetic
algorithm calculation is Contact Hologic Technical Support.
invalid.

ub The software has Control and associated samples are invalid.

reported a user bracket
control failure. Contact Hologic Technical Support.

x One or more of the Control and associated samples are invalid.

controls has been
invalidated, invalidating See additional results processing codes and
all specimens currently assay processing codes for more information.
being processed in the Contact Hologic Technical Support.
affected worklist.

z Invalid kinetic profile. Sample is invalid.

The total RLU value
was equal to zero for at Check all fluid connections. Contact Hologic
least one interval in the Technical Support.
kinetic curve.

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 Appendix B. Processing Flags

Table 117. Results Processing Flags (Continued)

Code Description Outcome
ze Invalid kinetic profile for Sample is invalid.
a sample.
Check all fluid connections. Contact Hologic
Technical Support.

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 Appendix C. System Messages

Appendix C. System Messages

Table 118. System Messages
Code Message Possible Cause Solution
257.000.00002 Instrument The issue could be 1. Remove all racks
initialization has due to one of the and close all doors
failed. following: and drawers.
l Panther System 2. If necessary, shut
software was down the software
not booted and ensure that the
properly. instrument has
been powered on
l Reagent or for 20 seconds
Sample Racks before restarting the
were loaded on software in the
the system at Desktop Shield.
startup.
3. If this does not
l Doors and work, shut down
Drawers were and restart the
not completely system.
closed.
4. If the problem
l The software persists, contact
was started Hologic Technical
before the Support.
instrument was
ready.
257.000.00003 Remove all racks A Reagent or 1. Remove racks from
and close all Sample Rack is the Sample and
drawers and doors loaded or a drawer Reagents Bays.
in order to continue and/or door may be 2. Close all drawers
initialization. open. and doors.
3. If the problem
persists, contact
Hologic Technical
Support.
257.000.00004 File {0} is missing System software or 1. Shutdown and
or it is corrupted. database error. restart.
2. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00008 MTU unload not Deactivation Buffer Ensure Deactivation
started. bottle A is not being Buffer bottle A is
Deactivation Buffer read by the RFID present in the
A bottle is missing sensor. Universal Fluids
or not connected. drawer and the two
Check the bottle arrows indicating the
and close the RFID sensor are
drawer. aligned.

257.000.00009 MTU unload not Deactivation Buffer Ensure Deactivation

started. bottle B is not being Buffer bottle B is
Deactivation Buffer read by the RFID present in the
B bottle is missing sensor. Universal Fluids
or not connected. drawer and the two
Check the bottle arrows indicating the
and close the RFID sensor are
drawer. aligned.

257.000.00010 MTU unload not Waste Drawer is 1. Firmly close the

started. Waste open or is not able Waste Drawer.
Drawer is open or to lock. 2. If the problem
not locked. persists, contact
Hologic Technical
Support.
257.000.00011 MTU unload not The issue could be 1. Open the Waste
started. Vacuum due to one of the Drawer and check
pump not on. following: that the Liquid
Waste Container is
l Liquid Waste securely fitted and
Bottle fitting is the cap is sealed.
not connected
properly. 2. Check if there is
any fluid in the
l The vacuum Vacuum Filter.
pump may be
malfunctioning. 3. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00012 MTU unload not The issue could be 1. Check that the
started. Insufficient due to one of the Liquid Waste Bottle
vacuum pressure. following: is secure in the
Waste drawer was drawer and the cap
unlocked. Check l The Liquid is on tight.
waste bottle. Waste Bottle
fitting is not 2. If the problem
properly seated persists, contact
or sealed. Hologic Technical
Support.
l The vacuum
pump is
malfunctioning.
257.000.00013 MTU unload not Universal Drawer is 1. Pull the Universal
started. Universal open or not locked. Fluids Drawer
Drawer not closed. completely forward
and then close it
completely.
2. If the problem
persists, contact
Hologic Technical
Support.
257.000.00014 MTU unload not The issue could be 1. Check the Liquid
started. Liquid due to one of the Waste volume.
Waste full. Waste following: 2. If the bottle is full,
drawer was empty the waste as
unlocked. Check l Liquid Waste
Bottle is full. directed in the
waste bottle. Operator's Manual.
l The sensor or
Liquid Waste 3. If the bottle is not
Bottle is full, contact Hologic
malfunctioning. Technical Support.

257.000.00015 MTU unload not The Waste Bag is 1. Make sure the
started. MTU waste missing or the Waste Bag and
bag not present. sensor is not Waste Cover are
Waste drawer was detecting the bag. properly installed.
unlocked. Check 2. If the problem
waste bottle. persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00019 MTU unload The instrument 1. Perform Force MTU
unsuccessful. failed to unload an Unload.
Could not unload MTU position. 2. If the problem
one position. persists, contact
Please run Force Hologic Technical
MTU Unload. Support.
257.000.00020 MTU unload The instrument 1. Perform Force
unsuccessful. failed to unload MTU Unload.
Could not unload MTUs in the
{0} positions. specified positions. 2. If the problem
Please run Force persists, contact
MTU Unload. Hologic
Technical
Support.

257.000.00021 Force MTU unload An instrument Contact Hologic

unsuccessful. hardware error has Technical Support.
caused one or more
MTU(s) to be left in
the system.

257.000.00027 Prime not started. Universal Fluid Kit Replace Universal

Universal fluid kit A A contains bottles Fluid Kit A.
contains expired which have reached
bottles. their expiration
date.

257.000.00028 Prime not started. Universal Fluid Kit Replace Universal

Universal fluid kit B B contains bottles Fluid Kit B.
contains expired which have reached
bottles. their expiration
date.

257.000.00030 Priming was not Fewer than the 1. Load additional

started because minimum number of MTUs and restart
there are not required MTUs are the prime.
enough MTUs in loaded in the Input 2. If the problem
the Input Queue. {0} Queue. persists, contact
are required but Hologic Technical
only {1} are Support.
available.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00031 Insufficient Solid There is not enough 1. Empty the waste
Waste capacity for waste capacity to and restart the
priming. complete prime. prime.
2. If the problem
persists, contact
Hologic Technical
Support.
257.000.00032 Insufficient Liquid There is not enough 1. Empty the waste
Waste capacity for waste capacity to and restart the
priming. complete prime. prime.
2. If the problem
persists, contact
Hologic Technical
Support.
257.000.00033 Prime not started There is not enough 1. Replace the
because the fluid inventory to depleted fluid and
remaining number complete prime. restart the prime.
of tests: {0} is 2. If the problem
smaller than the persists, contact
minimum number of Hologic Technical
tests: {1}. Support.
257.000.00034 Prime not started. The issue could be 1. Check the
Not all bottles have due to one of the Universal Fluids
been loaded for following: screen for the status
universal fluid Kit A. of the fluids drawer.
l Bottle(s) may be
missing for 2. Load the missing
universal fluid bottle(s) or rotate
Kit A. any misaligned
bottles until the
l Bottle(s) may bottles are properly
have shifted identified by the
while closing system.
drawer.
3. If the problem
l Sensor is not persists, contact
detecting a Hologic Technical
bottle. Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00035 Prime not started. The issue could be 1. Check the
Not all bottles have due to one of the Universal Fluids
been loaded for following: screen for the status
universal fluid Kit B. of the fluids drawer.
l Bottle(s) may be
missing for 2. Load the missing
universal fluid bottle(s) or rotate
Kit B. any misaligned
bottles until the
l Bottle(s) may bottles are properly
have shifted identified by the
while closing system.
drawer.
3. If the problem
l Sensor is not persists, contact
detecting a Hologic Technical
bottle. Support.
257.000.00036 Prime not started. The issue could be 1. Load or reload the
Bleach bottle is not due to one of the NaOCl Bottle.
loaded following: 2. Ensure that the
l NaOCl Bottle handle of the bottle
may be missing. is pointing towards
the center of the
l Sensor is not fluids drawer.
detecting the
bottle. 3. If the problem
persists, contact
Hologic Technical
Support.
257.000.00037 Prime not started. There is not enough 1. Replace fluid kit A
Insufficient tests in remaining fluid in kit and restart the
Universal fluid kit A. A to complete prime.
prime. 2. If the problem
persists, contact
Hologic Technical
Support.
257.000.00038 Prime not started. There is not enough 1. Replace fluid kit B
Insufficient tests in remaining fluid to and restart the
Universal fluid kit B. complete prime in prime.
kit B. 2. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00039 Prime not started. The issue could be 1. Ensure that the
Insufficient tests in due to one of the NaOCl bottle is
the Bleach bottle. following: filled to the
minimum fill line
l Not enough and the float sensor
volume in the is not remaining at
NaOCl bottle. the bottom of the
l Sensor is bottle.
detecting an 2. If the problem
empty bleach persists, contact
bottle. Hologic Technical
Support.
257.000.00040 Prime not started. The issue could be 1. Firmly close the
Waste Drawer not due to one of the Waste Drawer and
locked. following: restart the prime.
2. If the problem
l Waste Drawer is
open. persists, contact
Hologic Technical
l Sensor is not Support.
functioning
properly.
257.000.00041 Prime not started. The issue could be 1. Firmly close the
Universal Fluid due to one of the Universal Fluid
Drawer not closed. following: Drawer and restart
the prime.
l Universal Fluid
Drawer is open. 2. If the problem
persists, contact
l Sensor is not Hologic Technical
functioning Support.
properly.
257.000.00042 Failed to set System software or 1. Shutdown and
parameters for the database error. restart.
Magwashes, 2. If the problem
Luminometer and persists, contact
Output Queue. Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00043 Prime not started. The issue could be 1. Empty the waste
Waste inventory is due to one of the properly and restart
not valid. following: the prime.
l There is not 2. If the problem
enough persists, contact
remaining waste Hologic Technical
capacity to Support.
complete prime.
l The inventory is
invalid due to
hardware
issues.
257.000.00044 Prime not started. The issue could be 1. Attempt to correct
Universal Fluids due to one of the the fluid kit issue, if
inventory is not following: necessary, and
valid. restart the prime.
l There is not
enough 2. If the problem
remaining fluid persists, contact
to complete Hologic Technical
prime. Support.
l Bottle may be
missing.
l Sensor is not
detecting a
bottle.
l Fluid stability
has expired.
257.000.00045 Prime not started. The issue could be 1. Check that the
Vacuum pump due to one of the Liquid Waste Bottle
pressure is not in following: is secure in the
range. drawer and the cap
l The Liquid is on tight.
Waste Bottle
fitting is not 2. Restart prime if
properly seated able.
or sealed. 3. If the problem
l The vacuum persists, contact
pump is Hologic Technical
malfunctioning. Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00046 Scheduled prime The system was not Start the prime
has been cancelled in a proper state at manually when able.
because the state the time the prime
was not Setup or had been
Ready. scheduled.

257.000.00051 Mag Wash Station There was a Mag 1. Perform Mag Wash
{0} is out of service Wash error during Clean maintenance
during priming. prime. task when able (see
Repeat priming. If Mag Wash Clean
error reoccurs, run on page 200).
Mag Wash Clean. 2. Repeat prime to
check the
effectiveness of the
procedure.
3. If the problem
persists, contact
Hologic Technical
Support.
257.000.00056 Prime failed. Output Output Queue error 1. Shutdown and
Queue calibration during calibration. restart.
failure for 2. Repeat prime.
Deactivation Buffer. 3. If the problem
persists, contact
Hologic Technical
Support.
257.000.00057 Prime failed. Output Output Queue error 1. Shutdown and
Queue calibration during calibration. restart.
failure for Bleach. 2. Repeat prime.
3. If the problem
persists, contact
Hologic Technical
Support.
257.000.00061 Prime failed with Luminometer error 1. Shutdown and
Luminometer during prime. restart.
errors. 2. Repeat prime.
3. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00062 Prime failed with There was a Mag 1. Perform Mag Wash
Mag Wash errors. Wash error during Clean maintenance
prime. task when able (see
Mag Wash Clean
on page 200).
2. Repeat prime to
check the
effectiveness of the
procedure.
3. If the problem
persists, contact
Hologic Technical
Support.
257.000.00063 Prime failed with There was an 1. Shutdown and
Output Queue Output Queue error restart.
errors. during prime. 2. Repeat prime.
3. If the problem
persists, contact
Hologic Technical
Support.
257.000.00064 Priming has See accompanying 1. Correct any errors
finished, with message(s) to and repeat prime.
errors. determine cause. 2. If the problem
persists, contact
Hologic Technical
Support.
257.000.00065 Priming has See accompanying 1. Correct any errors
finished, with message(s) to and repeat prime.
errors. determine cause. 2. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00066 Oil bottle A and/or The issue could be 1. Check that the Oil
Oil bottle B is empty due to one of the bottles have fluid
or not connected. following: remaining and the
Please check bottle fittings are securely
connections. l Oil fitting is not connected.
connected
properly. 2. Restart the prime.
l Oil sensor 3. If the problem
malfunction. persists, contact
Hologic Technical
Support.
257.000.00067 Aspirator number The issue could be 1. Check and make
{1} on magwash {0} due to one of the sure MTUs have all
does not have a following: tiplets prior to
tiplet present. loading.
l Tiplet was
missing from an 2. If the problem
MTU. persists, contact
Hologic Technical
l Tiplet fell after Support.
being picked up.
257.000.00069 Prime failed. Check The system 1. Retry priming the
universal fluid detected that the system.
bottles and repeat priming of fluids 2. If the problem
prime. was unsuccessful. persists, contact
Hologic
Technical
Support.

257.000.00080 Automatic Auto Detect 1 pump 1. Shutdown and

calibration of the error during restart.
Auto Detect 1 pump calibration. 2. Repeat the prime.
failed during 3. If the problem
priming. persists, contact
Hologic Technical
Support.
257.000.00082 Automatic Auto Detect 2 pump 1. Shutdown and
calibration of the error during restart.
Auto Detect 2 pump calibration. 2. Repeat the prime.
failed during 3. If the problem
priming. persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00084 Automatic Oil pump error 1. Shutdown and
calibration of the Oil during calibration. restart.
pump failed during 2. Repeat the prime.
priming. 3. If the problem
persists, contact
Hologic Technical
Support.
257.000.00086 Automatic Wash Buffer pump 1. Shutdown and
calibration of the error during restart.
Wash Buffer pump calibration. 2. Repeat the prime.
failed during 3. If the problem
priming. persists, contact
Hologic Technical
Support.
257.000.00087 Automatic N/A No action necessary.
calibration of the
Wash Buffer
executed
successfully during
prime.

257.000.00090 Luminometer N/A No action necessary.

calibration factor
set to {0}.

257.000.00091 Failed to set System Initialization 1. Shutdown and

luminometer error. restart.
calibration factor to 2. If the problem
{0}. persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00100 Instrument is The Panther UPS is 1. Ensure that the
running on battery no longer receiving UPS is connected
power. power from the to the facility power
facility. source.
2. Contact local
facilities team for
investigation.
3. Contact Hologic
Technical support if
facilities
investigation shows
power source is
functional.
257.000.00101 Battery life is on The battery level This is an informational
{0}%. Performing has dropped under message. Please allow
safe shutdown. the warning limit. system to safely shut
down.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00102 Battery life is on The battery level This is an informational
{0}%. Performing has dropped under message. Please allow
shutdown. the critical limit. system to safely shut
down. Once the system
has safely shut down:
1. Switch the
instrument power to
the off position.
2. Remove and store
any reagents or
samples that were
on-board the
instrument.
3. Ensure that the
UPS is connected
to the facility power
source.
4. Contact local
facilities team for
investigation.
5. Contact Hologic
Technical support if
facilities
investigation shows
power source is
functional.
257.000.00103 Switched from Power connection 1. Ensure power cord
outlet power to for the system is not for the system is
battery power. connected or connected at both
Battery lifetime is malfunctioning. ends.
on {0}%; 2. Contact Hologic
discharging. Technical Support if
the connection is
not re-established
after checking the
connection.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00104 Switched from Power connection No action necessary.
battery power to is established.
outlet power.
Battery lifetime is
on {0}%; charging.

257.000.00105 Communication USB connection 1. Ensure the USB

with the from the Panther cable running from
uninterruptible PC to the UPS is the UPS to the
power supply was not connected or Panther PC is
lost. malfunctioning. connected at both
ends.
2. Contact Hologic
Technical Support if
the connection is
not re-established
after checking the
connection.
257.000.00106 Communication USB connection to No action necessary.
with the the UPS is
uninterruptible established.
power supply was
established.

257.000.00107 Battery life detected During startup, the 1. Ensure that the
under the warning system detected the UPS is connected
threshold during battery level is to the facility power
startup. below the warning source.
limit. 2. Contact local
facilities team for
investigation.
3. Contact Hologic
Technical support if
facilities
investigation shows
power source is
functional.
257.000.00150 Request to enter to There are currently Unload or allow the
Power Save state test orders loaded system to process the
ignored. Test on the instrument test orders.
orders are waiting which are waiting to
to be processed. be processed.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
257.000.00151 System exited from The system is No action necessary.
Power Save. allowing the
Incubator warm-up incubators to reach
may take up to 33 their operating
minutes. temperature.

257.000.00200 The Output Queue The system Contact Hologic

module does not detected an Technical Support.
have the sensor anomaly with the
calibration values Output Queue.
persisted. Please
contact FSE.

257.000.00201 The Luminometer The system Contact Hologic

module does not detected an Technical Support.
have the sensor anomaly with the
calibration values Luminometer.
persisted. Please
contact FSE.

257.000.00210 Failed to power The system 1. Shutdown the

cycle the detected that the Panther software
instrument. Please instrument was not and the Panther
shutdown software power cycled PC.
and manually (turned off, then 2. Switch the
power cycle the turned on) during a instrument power to
instrument. system reboot. the off position.
3. Wait 30 seconds.
4. Switch the
instrument power to
the on position and
power on the
Panther PC.
258.000.00002 Waste drawer could Waste Drawer is not 1. Firmly close the
not be locked. closed properly. Waste Drawer and
restart the prime.
2. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
258.000.00003 Waste drawer could The issue could be 1. Hold drawer in
not be unlocked. due to one of the while unlocking.
following: 2. If this fails,
l The Waste shutdown and
Drawer is restart.
closed 3. If the problem
improperly. persists, contact
l Faulty lock Hologic Technical
mechanism. Support.

258.000.00004 The sample rack in The sample rack 1. Ensure the

lane {0} has an barcode in the barcodes on the
invalid type or specified lane is sample rack are not
unique id. The rack unreadable. damaged or faded.
cannot be 2. Retry loading the
accepted. Please rack.
make sure that the 3. If problem persists,
barcode labels are use another rack
not damaged. and contact Hologic
Technical Support
for replacement.
258.000.00005 The pipettor System error. 1. Restart the system
coordinates for and reload the
sample rack in lane Sample Rack.
{0} could not be 2. If the problem
downloaded. The persists, contact
rack cannot be Hologic Technical
pipetted. Support.
258.000.00006 One of the tip The tip drawer is 1. Press firmly on the
drawers appears as not fully closed tip drawer to ensure
being open though even though it is that it is fully closed.
locked. Please currently locked. 2. If the door does not
check the drawers. stay closed contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
258.000.00007 Multiple pipettor tip The pipettor 1. Ensure the tip
pickup failures attempted to pick tray is seated
detected. {0} tray on tips from the correctly inside
{1} drawer marked specified tip tray the tip drawer.
empty. and was
unsuccessful. 2. Ensure only
Hologic
recommended
pipettor tips are
being used.
3. If the problem
persists, contact
Hologic
Technical
Support.

258.000.00009 Rack loading error. Sample Rack 1. Pull the Sample

Barcode Scanner loaded prior to lane Rack out and
failed to focus on focus or the rack reload into correct
lane {0} in the {1}. was loaded into the lane after the lane
wrong lane. LED flashes
green.
2. If the problem
persists, contact
Hologic
Technical
Support.

258.000.00010 The {0} door is A door is open or 1. Properly close all

open. Please close there is a faulty door doors.
the {0} door. mechanism.
2. If the problem
persists, contact
Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
258.000.00011 Cannot unlock Current state does 1. Wait for unlock
waste drawer in not allow the Waste option to be
current state. Drawer to be available.
unlocked. 2. If the problem
persists, contact
Hologic Technical
Support.
258.000.00012 Waste bag is Solid Waste bag is 1. Make sure a waste
missing. Load an missing, or the bag is properly
empty waste bag. sensor is not installed and flush
detecting the bag. against the walls.
2. If the problem
persists, contact
Hologic Technical
Support.
258.000.00013 Locking or stacking The issue could be 1. Unlock MTU
of the MTUs in the due to one of the drawer, pull open
Input Queue failed. following: and investigate the
MTU arrangement.
MTUs were not
loaded properly. 2. Ensure all MTUs
are loaded properly.
There is an MTU 3. Close drawer.
jam in the Input 4. If the problem
Queue. persists, contact
Hologic Technical
Support.
258.000.00014 TCR door failed to The TCR door 1. Press firmly on
lock. Open and failed to lock. the TCR door.
close the door to
retry locking the 2. If the problem
door. persists, contact
Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
258.000.00015 TCR door failed to The TCR door 1. Press firmly on
unlock. Ensure that failed to unlock. The the TCR door in
the TCR door is TCR door may not an attempt to
fully pushed closed. be fully closed even have the door
though it is currently unlock itself.
locked.
2. If the problem
persists, contact
Hologic
Technical
Support.

258.000.00016 Software failure Database integrity 1. Retry loading or

during data issue. restart the system.
download. Please 2. If the problem
retry loading or persists, contact
restart the system. Hologic Technical
Support.
258.000.00020 The Panther Liquid The issue could be 1. Check the Liquid
Waste is full. due to one of the Waste volume.
following: 2. If the bottle is full,
l Liquid Waste empty the waste as
Bottle is full. directed in the
Operator's Manual.
l The sensor or
Liquid Waste 3. If the bottle is not
Bottle is full, contact Hologic
malfunctioning. Technical Support.

258.000.00021 System was unable System software 1. Ensure tip inventory

to restore the error. is correct and
Panther tip count. update inventory as
Please perform a necessary.
tip inventory and 2. If the problem
ensure that persists, contact
onscreen tip count Hologic Technical
matches the tips in Support.
the drawers. Load
more tips if
necessary.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
258.001.00004 The reagent rack in The reagent rack 1. Ensure the
lane {0} has an barcode in the barcodes on the
invalid type or specified lane is reagent rack are not
unique id. The rack unreadable. damaged or faded.
cannot be 2. Retry loading the
accepted. Please rack.
make sure that the 3. If problem persists,
barcode labels are use another rack
not damaged. and contact Hologic
Technical Support
for replacement.
259.000.00001 System stopped System software or 1. Shutdown and
due to a fatal error. instrument restart.
System needs to be hardware error. 2. If the problem
restarted. persists, contact
Hologic Technical
Support.
259.000.00002 Assay processing Fatal system error. 1. Shutdown and
was aborted due to restart.
a fatal error. System 2. If the problem
need to be persists, contact
restarted. Hologic Technical
Support.

259.000.00011 Unexpected MTU MTU barcode 1. Check all MTUs

barcode. Samples peeled off or is before loading to
{3} were affected. damaged. ensure that
MTU {0} has a barcodes are
different barcode: present and
{1} instead of {2}! undamaged.
2. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00013 Unable to read MTU barcode 1. Check all MTUs
barcode of MTU {0}. peeled off or is before loading to
damaged. ensure that
barcodes are
present and
undamaged.
2. If the problem
persists, contact
Hologic Technical
Support.
259.000.00017 Setting parameter System software or 1. Shutdown and
sets for {0} failed. database error. restart.
2. If the problem
persists, contact
Hologic Technical
Support.
259.000.00018 Start of assay N/A No action necessary.
processing at {0}.

259.000.00019 No introduction of System software or 1. Shutdown and

new MTU in cycle database error. restart.
{0}. 2. If the problem
persists, contact
Hologic Technical
Support.
259.000.00022 No adequate oil Oil dispense failure. 1. Retest affected
volume available Check any sample(s).
for a new MTU. accompanying 2. Wait for assay
Cannot process message for processing
assay. possible cause of completion and
failure. Possible ensure the Oil
causes of failure: volume and bottle
l Oil Pump failure. connection are
intact.
l Empty Oil Bottle
or improper 3. If the problem
bottle persists, contact
connection. Hologic Technical
Support.
l Associated
hardware
failure.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00023 No adequate Wash Wash dispense 1. Retest affected
volume available failure. Check any sample(s).
for a new MTU. accompanying 2. Wait for assay
Cannot process message for processing
assay. possible cause of completion and
failure. Possible ensure the Wash
causes of failure: volume and bottle
l Wash Pump connection are
failure. intact.
l Empty Wash 3. If the problem
Bottle or persists, contact
improper bottle Hologic Technical
connection. Support.
l Clogged
dispense
fittings.
259.000.00024 There is no reagent System software or 1. Shutdown and
kit for assay={0} database error. restart.
and {1} tests. 2. If the problem
Cannot process persists, contact
assay. Hologic Technical
Support.
259.000.00025 Couldn't reserve The waste is full Empty the waste
waste for a leading and cannot accept through the Tasks
prime MTU, can't anymore waste. screen.
process.

259.000.00029 Last move before System software or 1. Shutdown and

Fluorescence database error. restart.
Measurement Step 2. If the problem
did not place MTU= persists, contact
{0} to Incubator3 (= Hologic Technical
Fluorometer). Support.
Unable to execute
measurement
command.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00030 Necessary RTFs System software or 1. Shutdown and
missing for database error. restart.
fluorescence 2. If the problem
measurement ({0}, persists, contact
{1}). Hologic Technical
Support.
259.000.00032 Destination of the System software or 1. Shutdown and
last move ({0}) database error. restart.
differs from source 2. If the problem
of current move persists, contact
({1})! Hologic Technical
Support.
259.000.00034 No adequate Auto Auto Detect 1. Retest affected
Detect {0} volume dispense failure. sample(s).
available for a new Check any 2. Wait for assay
MTU. Cannot accompanying processing
process assay. message for completion and
possible cause of ensure the Auto
failure. Possible Detect volume and
causes of failure: bottle connection
l Auto Detect are intact.
Pump failure. 3. If the problem
l Empty Auto persists, contact
Detect Bottle or Hologic Technical
improper bottle Support.
connection.
l Associated
hardware
failure.
259.000.00037 Processing failure. System software or 1. Shutdown and
Enabling Block {0}. database error. restart.
2. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00038 Processing failure. System software or 1. Shutdown and
Sending Block {0}. database error. restart.
2. If the problem
persists, contact
Hologic Technical
Support.
259.000.00039 Processing failure. System software or 1. Shutdown and
COP internal timer. database error. restart.
2. If the problem
persists, contact
Hologic Technical
Support.
259.000.00041 All temperatures in N/A No action necessary.
range. Resumed
sample pipetting.

259.000.00043 RDV Error {0} Reagent Dispense 1. Retest affected

during aspiration of Verification error sample(s).
SID {1}. during aspiration for 2. If the problem
the sample persists, contact
identified. Hologic Technical
Support.
259.000.00044 RDV Error {0} Reagent Dispense 1. Retest affected
during {1} Verification error sample(s).
dispensing for SID during dispense for 2. If the problem
{2}. the sample persists, contact
identified. Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00045 {0} for {1} in lane An LLD error 1. Ensure only
{2}. occurred for a Hologic specified
specific reagent. pipettor tips are
being used
l For LLDTooLow
errors, it is 2. Ensure Hologic
possible come procedures are
reagent may being followed
have spilled out during reagent
or was removed preparation.
while popping 3. If the problem
bubbles. persists, contact
l For Hologic
LLDTooHigh Technical
errors, it is Support.
possible there is
a hardware
issue or the
reagents were
pooled together.
259.000.00046 MTU barcode {0} The issue could be If the problem persists,
has been used due to one of the contact Hologic
before. following: Technical Support.
l Misread MTU
barcode.
l MTU Barcode
Scanner error.
259.000.00047 Sample pipettor A tip fell off the 1. Ensure only
dropped a tip inside pipettor arm and is Hologic specified
a reagent bottle. inside a reagent pipettor tips are
bottle. being used.
2. Contact Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00048 Sample pipettor A tip fell off the 1. Ensure only
dropped a tip pipettor arm and is Hologic specified
outside a reagent inside the pipettor tips are
bottle. instrument. being used.
2. Contact Hologic
Technical
Support.

259.000.00049 The Sample Bay The issue could be 1. Check ambient

temperature is out due to one of the temperature to
of range. Stopped following: ensure it is within
sample pipetting. the allowed
l Lab operating range.
Temperature out
of range. 2. Limit the amount of
time the Sample
l Faulty Bay Door is open.
Temperature
sensor. 3. Wait for the
temperature to lock
l Faulty cooling once the
module. temperature is back
in range.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00050 The Reagent Bay The issue could be 1. Check ambient
temperature is out due to one of the temperature to
of range. Stopped following: ensure it is within
sample pipetting. the allowed
l Lab operating range.
Temperature out
of range. 2. Limit the amount of
time the Reagent
l Faulty Bay Door is open.
Temperature
sensor. 3. Wait for the
temperature to lock
l Faulty cooling once the
module. temperature is back
in range.
4. If the problem
persists, contact
Hologic Technical
Support.
259.000.00051 Sample pipettor A tip may be lost in 1. Select Help and
dropped a tip in the Sample Bay or refer to the Dropped
rack lane {0} inside stuck in a Tip Inside Sample
sample tube {1}. penetrable cap. Tube instructions
Please wait for within the
message indicating Troubleshooting
that it is safe to section (see
open the right Dropped Tip Inside
canopy door. Sample Tube on
page 262).
2. Do not attempt to
access the dropped
tip until the system
generates a
message that it is
safe to open the
Right Canopy Door.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00052 Sample pipettor A tip may be lost in 1. If the tip is visible,
dropped a tip the Upper Bay. wait for assay
outside sample processing to
tube. Processing complete before
will continue. attempting to
remove the tip.
2. Follow the Clean
the Sample Shield
task to gain access
to the Upper Bay
(see Clean the
Sample Shield on
page 201).
3. Carefully remove
the dropped tip with
a damp paper towel
and dispose of the
tip according to lab
procedures.
4. If no tip is present,
contact Hologic
Technical Support.
259.000.00053 Reagent pipettor A tip may be lost in 1. Wait for the system
dropped a tip inside a reagent bottle. to complete
a reagent bottle. processing before
attempting to
remove the affected
reagents.
2. Contact Hologic
Technical Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00054 Reagent pipettor A tip may be lost in 1. If the tip is visible,
dropped a tip the Upper Bay. wait for assay
outside a reagent processing to
bottle. complete before
attempting to
remove the tip.
2. Shut down the
system before
attempting to
access the Upper
Bay.
3. Once shut down,
open the Left
Canopy Door and
carefully remove
the dropped tip with
a damp paper towel
and dispose of the
tip according to lab
procedures.
4. If no tip is present,
contact Hologic
Technical Support.
259.000.00055 Cannot move MTU Mag Wash station is 1. Perform Mag Wash
to device {0} out of service. Clean maintenance
because it is out of task when able (see
service! Mag Wash Clean
on page 200).
2. Repeat prime to
check the
effectiveness of the
procedure.
3. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00056 There is no There is not enough 1. Replace the fluid
universal fluid set remaining fluid to inventory when the
for {0} tests. Cannot complete all of the system is in the
process assay. loaded samples. Setup or Ready
state.
2. If the problem
persists, contact
Hologic Technical
Support.
259.000.00057 Setting internal System Initialization 1. Shutdown and
parameter sets error. restart.
failed! 2. If the problem
persists, contact
Hologic Technical
Support.
259.000.00063 No deactivation The Deactivation 1. Assay processing is
fluid buffer or Buffer or NaOCl discontinued.
bleach available. Bottle is empty or 2. Check the NaOCl
not connected. and Deactivation
Buffer bottles and
connections.
3. Replace fluids as
necessary.
4. If the problem
persists, contact
Hologic Technical
Support.
259.000.00064 At least one device Device out of 1. Shutdown and
is out of service, service. restart.
preventing the start 2. If the problem
of assay persists, contact
processing. Hologic Technical
Support.
259.000.00066 Sample Pipetting High background If multiple incidences of
paused due to light reading prior to high background reads
Luminometer high Auto Detect are reported, contact
background. injection. Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00067 Assay processing N/A No action necessary.
has returned to full
throughput.

259.000.00068 Sample pipetting Both Mag Wash 1. Allow the system to

paused due to Stations are out of attempt to recover
problems at both service either due to from the error state.
Mag Washes. a hardware error or 2. Attempt to run a
clogged aspirators. Mag Wash Clean
maintenance task.
3. If the problem
persists, contact
Hologic
Technical
Support.

259.000.00071 Sample rack in lane Sample rack 1. Inspect the Sample

{0} was removed removed while in Rack Retainer and
while in use. use. all sample tubes in
Unpipetted the affected rack for
samples associated droplets and
with the currently replace sample
pipetting MTU will caps as needed.
be invalidated. 2. Re-load all affected
Inspect rack samples for testing.
retainer and sample 3. Do not remove
tubes for droplets Sample Racks
and replace sample when they are
caps as needed. being pipetted.
4. Only remove
Sample Racks in
lanes with a green
LED or when the
LED is off.
5. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00072 Reagent rack in Reagent rack 1. All in-process
lane {0} was removed while in samples associated
removed while in use. with this kit will be
use. All in-process invalidated.
samples associated 2. Re-load the
with this kit will be Reagent Rack and
invalidated. retest all affected
samples.
3. Do not remove
Reagent Racks
when they are in
process.
4. Only remove
Reagent Racks in
lanes with a green
LED.
259.000.00073 Too soon after rack The issue could be 1. Wait for sample
removal to load due to one of the lane LED to flash
sample bay lane {0} following: green prior to
again. Please try loading sample
again. l Sample Bay rack.
lane not ready
for new sample 2. Try again.
rack. 3. If the problem
l Rack loaded too persists, contact
quickly. Hologic Technical
Support.
259.000.00074 Too soon after rack The issue could be 1. Wait for sample
removal to load due to one of the lane LED to flash
reagent bay lane following: green prior to
{0} again. Please loading sample
try again. l Reagent Bay rack.
lane not ready
for new sample 2. Try again.
rack. 3. If the problem
l Rack loaded to persists, contact
quickly. Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00075 Canopy door Canopy door open 1. Close the canopy
opened, please was opened. door. Leaving the
close. door open too long
or opening the door
repeatedly will
crash the system.
2. If the problem
persists after
closing the door,
contact Hologic
Technical Support.
259.000.00076 Sample pipetting See accompanying 1. Correct any errors,
has stopped. message(s) to then continue.
determine cause. 2. If the problem
persists, contact
Hologic Technical
Support.
259.000.00077 Assay processing One of the two Mag 1. Wait for assay
will continue at a Wash stations has processing
reduced throughput been taken out of completion.
due to Mag Wash service. 2. Perform Mag Wash
error. Clean maintenance
procedure when in
the Setup or Ready
state (see Mag
Wash Clean on
page 200).
3. Prime the
instrument to test
the effectiveness of
the cleaning.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00079 Right canopy door A tip may be lost in 1. Select Help and
can now be a sample tube. refer to the Dropped
opened. Please Tip Inside Sample
refer to help for Tube instructions
specific instructions within the
for safely removing Troubleshooting
the tip. section (see
Dropped Tip Inside
Sample Tube on
page 262).
2. After opening the
Right Canopy Door,
do not attempt to
remove the dropped
tip if the tip is stuck
in the tube.
3. Press the tip down
into the sample
tube as far as
possible before
attempting to
remove the affected
Sample Rack.
4. Close the canopy
door when finished
and select Resume
on the Sample
Rack Bay screen to
continue sample
pipetting.
259.000.00080 Please close the The system is 1. Select Resume on
sample canopy paused to allow for the Sample Rack
door and press the the removal of a Bay screen to
Resume button on dropped tip. continue sample
the sample rack pipetting following
bay screen. pipetting pause.
2. If the assay fails to
resume, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00081 Instrument could Jammed MTU in 1. Open the MTU
not pick an MTU input queue. Input Queue and
out of the input check for a jammed
queue. MTU.
2. Remove any
affected MTUs.
3. If the problem
persists, contact
Hologic Technical
Support.
259.000.00082 Sample pipetting is The operator has Click the Resume
still paused. Press chosen to pause button to allow the
resume button if sample pipetting. system to continue
pipetting may pipetting.
resume.

259.000.00086 The temperature of The Sample Bay 1. Ensure the ambient

the Sample bay has temperature temperature is
not returned to the remained out of within the allowed
acceptable range. range for a range for the
Transitioning to prolonged duration. Panther System.
error state. The system 2. If the problem
transitioned to an persists, contact
Error state. Hologic Technical
Support.
259.000.00087 The temperature of The Reagent Bay 1. Ensure the ambient
the Reagent bay temperature temperature is
has not returned to remained out of within the allowed
the acceptable range for a range for the
range. prolonged duration. Panther System.
Transitioning to The system 2. If the problem
error state. transitioned to an persists, contact
Error state. Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00088 Oil Process Control The system 1. Ensure the oil
Check failed for detected that an bottle is not
SIDs {0} insufficient amount empty due to
of oil was possible spilling
dispenses into the on the fluid.
MTU.
2. Replace the fluid
kit
3. If still occurring,
replace the fluid
bottle cap.
4. If the problem
persists, contact
Hologic
Technical
Support.

259.000.00089 Stopped The issue could be 1. Allow processing

introduction of new due to one of the to continue, as
samples after {0} following: necessary.
consecutive
reagent volume l Sample pipettor 2. Shut down and
check errors of the hardware or restart once the
sample pipettor. calibration error. Shutdown button
l Not enough is available on
volume in the
Specimen Logoff/Shutdown
Samples. screen.
3. Contact Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00090 Stopped Reagent pipettor 1. Allow processing
introduction of new hardware or to continue, as
samples after {0} calibration error. necessary.
consecutive
reagent volume 2. Shut down and
check errors of the restart once the
reagent pipettor. Shutdown button
is available on
the
Logoff/Shutdown
screen.
3. Contact Hologic
Technical
Support.

259.000.00091 Stopped The issue could be 1. Allow processing

introduction of new due to one of the to continue, as
samples after {0} following: necessary.
consecutive
reagent dispense l Sample pipettor 2. Shut down and
check errors of the hardware or restart once the
sample pipettor. calibration error. Shutdown button
l Not enough is available on
volume in the
Specimen Logoff/Shutdown
Samples. screen.
3. Contact Hologic
Technical
Support.

259.000.00092 The High-Temp The issue could be 1. The sample pipettor

incubator due to one of the will remain paused
temperature is out following: until the incubator
of range. Paused temperature locks.
sample pipetting. l High-Temp
Incubator out of 2. If the incubator is
range. taken out of service
or the error is seen
l Faulty frequently, contact
Temperature Hologic Technical
sensor. Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00093 The Transition The issue could be 1. The sample pipettor
incubator due to one of the will remain paused
temperature is out following: until the incubator
of range. Paused temperature locks.
sample pipetting. l Transition
Incubator out of 2. If the incubator is
range. taken out of service
or the error is seen
l Faulty frequently, contact
Temperature Hologic Technical
sensor. Support.
259.000.00094 The Amp incubator The issue could be 1. The sample pipettor
temperature is out due to one of the will remain paused
of range. Paused following: until the incubator
sample pipetting. temperature locks.
l Amp Incubator
out of range. 2. If the incubator is
taken out of service
l Faulty or the error is seen
Temperature frequently, contact
sensor. Hologic Technical
Support.
259.000.00095 The heater ramp The issue could be 1. The sample pipettor
temperature is out due to one of the will remain paused
of range. Paused following: until the Heat Ramp
sample pipetting. temperature locks.
l Heater Ramp
out of range. 2. If the ramp is taken
out of service or the
l Faulty error is seen
Temperature frequently, contact
sensor. Hologic Technical
Support.
259.000.00096 The chiller The issue could be 1. The sample pipettor
temperature is out due to one of the will remain paused
of range. Paused following: until the Chiller
sample pipetting. temperature locks.
l Chiller out of
range. 2. If the Chiller is
taken out of service
l Faulty or the error is seen
Temperature frequently, contact
sensor. Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00097 The instrument The issue could be 1. The sample pipettor
temperature is out due to one of the will remain paused
of range. Paused following: until the internal
sample pipetting. temperature locks.
l Lab temperature
is outside of the 2. If the system is
recommended taken out of service
range. or the error is seen
frequently, contact
l Faulty Hologic Technical
Temperature Support.
sensor.
259.000.00098 Magwash tip strip The Mag Wash 1. Retest the affected
failure for SID {0}. failed to remove the sample.
wash tiplet 2. Monitor for
correctly. recurrence of this
error.
3. If the problem
persists, contact
Hologic Technical
Support.
259.000.00100 The Sample Bay The Sample Bay 1. Ensure ambient
temperature is out temperature is temperature is
of range. outside of the within the operating
operating range. range.
2. Ensure there is no
external heat
source exhausting
on the left-hand
side of the
instrument. If the
temperature does
not come back to
operating range
contact Hologic
Technical Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.000.00101 The Reagent Bay The Reagent Bay 1. Ensure ambient
temperature is out temperature is temperature is
of range. outside of the within the operating
operating range. range.
2. If the temperature
does not come back
to operating range
contact Hologic
Technical Support.
259.000.00103 Assay processing A tip fell off the 1. Attempt to find the
cannot start due to pipettor arm and is lost tip inside the
a previous tip loss inside the instrument.
problem. Please instrument. The 2. If found, press the
correct the situation system cannot start Resume button to
and press the assay processing allow assay
resume button. until the tip has processing to
been found and continue.
removed. 3. If not found contact
Hologic Technical
Support.
259.000.00104 Sample pipetting is A tip fell off the 1. Attempt to find the
still paused due to pipettor arm and is lost tip inside the
tip loss. Please inside the instrument.
correct the situation instrument. The 2. If found, press the
and press the system cannot start Resume button to
resume button. assay processing allow assay
until the tip has processing to
been found and continue.
removed. 3. If not found contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.001.00043 RDV Error {0} An RDV error has 1. Ensure only
during {1} occurred during Hologic specified
aspiration in lane reagent aspiration. pipettor tips are
{2}. being used.
2. Ensure reagent
kit was correctly
reconstituted and
no bubbles are
present.
3. If the problem
persists, contact
Hologic
Technical
Support.

259.001.00044 RDV Error {0} An RDV error has 1. Ensure only

during {1} occurred during Hologic specified
dispensing. reagent dispensing. pipettor tips are
being used.
2. Ensure reagent
kit was correctly
reconstituted and
no bubbles are
present.
3. If the problem
persists, contact
Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.001.00045 {0} for {1} in An LLD error 1. Ensure only
quadrant {2}. occurred for a Hologic specified
specific reagent. pipettor tips are
being used
l For LLDTooLow
errors, it is 2. Ensure Hologic
possible come procedures are
reagent may being followed
have spilled out during reagent
or was removed preparation.
while popping
bubbles. 3. If the problem
persists, contact
l For consistent Hologic
LLDTooHigh Technical
errors, it is Support.
possible there is
a hardware
issue or the
reagents were
pooled together.
259.001.00085 CRC Failure in Database integrity 1. Shutdown and
flashcurve for SID check failure. restart.
{0}, Assay {1}. 2. If the problem
persists, contact
Hologic Technical
Support.

259.002.00043 RDV Error {0} An RDV error has 1. Ensure only

during {1} occurred during Hologic specified
aspiration in reagent aspiration. pipettor tips are
quadrant {2}. being used.
2. Ensure reagent
kit was correctly
reconstituted and
no bubbles are
present.
3. If the problem
persists, contact
Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
259.003.00043 RDV Error {0} The issue could be 1. Ensure fluid
during {1} due to one of the being aspirated is
aspiration. following: not bubbly,
expired or filled
l Possible fluid incorrectly.
issue.
l Faulty pipettor 2. Replace pipettor.
pump.
259.003.00045 {0} for SID {1}. An LLD error 1. Ensure the
occurred for a correct volume of
specific sample. sample was
added to the
sample tube.
2. If the problem
persists, contact
Hologic
Technical
Support.

261.000.00003 Invalidated Sample See accompanying 1. Retest the affected

ID {1} for {2} assay code(s) to sample.
in lane {3} position determine cause. 2. Contact Hologic as
{4} due to {0} flag. appropriate for the
Sample will need to particular failure
be retested. mode.
261.000.00006 Controls failed for During Assay 1. Check associated
{2} reagent kit Processing, the messages for more
loaded in lane {0}. controls are information.
SIDs in worklist {1} detected as invalid 2. Contact Hologic
are invalid. by the system. Technical Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
261.000.00007 Calibrators failed The calibrator and 1. Retest the
for assay reagent all samples tested invalidated
kit loaded in lane in the same worklist samples.
{0}. SIDs in worklist are invalidated. See 2. Troubleshoot the
{1} are invalid. accompanying cause of the failure
messages for cause according to the
of calibrator failure. accompanying
message.
3. Contact Hologic
Technical Support
for further
assistance.
261.000.00009 Liquid level The volume of the Contact Hologic
detected in reagent reagent is lower Technical Support if no
'{0}' from rack {1} / than expected. The volume was lost in the
position {2} is lower test level of the affected reagent prior to
than expected. Test reagent kit is loading.
counts have been adjusted to the new
adjusted to match volume of the
the volume of the affected reagent.
reagent.

261.000.00010 Assay {0}:{1} Name A software issue 1. Collect logs using

{2} version {3} not occurred while the Send Logs
loaded. Problems loading the assay feature (see Send
detected while listed in the Logs on page
loading the message. 259).
associated DLL.
2. Contact Hologic
Technical
Support.

261.000.00011 Assay {0}:{1} Name A software issue 1. Collect logs using

{2} version {3} occurred while the Send Logs
cannot be used. loading the assay feature (see Send
Problems detected listed in the Logs on page
when the system message. 259).
attempted to load
the Assay. 2. Contact Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
261.000.00013 {0} flag assigned to An assay 1. See Appendix B.
Sample ID {1} for processing error Processing Flags
{2} assay in lane {3} occurred with a on page 272 for
position {4}. sample that is still explanation.
on board the
instrument. 2. Take appropriate
steps to resolve
flag status.
3. Contact Hologic
Technical
Support.

261.000.00014 {0} flag assigned to An assay 1. See Appendix B.

Calibrator ID {1} for processing error Processing Flags
{2} assay in lane {3} occurred with a on page 272 for
position {4}. calibrator that is still explanation.
on board the
instrument. 2. Take appropriate
steps to resolve
flag status.
3. Contact Hologic
Technical
Support.

261.000.00015 {0} flag assigned to An assay 1. See Appendix B.

Control ID {1} for {2} processing error Processing Flags
assay in lane {3} occurred with a on page 272 for
position {4}. control that is still explanation.
on board the
instrument. 2. Take appropriate
steps to resolve
flag status.
3. Contact Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
261.000.00016 Invalidated Sample An assay 1. See Appendix B.
ID {1} for {2} assay processing error Processing Flags
in rack {3} due to {0} occurred with a on page 272 for
flag. Sample will sample that is still explanation.
need to be retested. on board the
instrument. 2. Take appropriate
steps to resolve
flag status.
3. Contact Hologic
Technical
Support.

261.000.00017 {0} flag assigned to An assay 1. See Appendix B.

Sample ID {1} for processing error Processing Flags
{2} assay in rack occurred with a on page 272 for
{3}. sample that has explanation.
been removed from
the instrument. 2. Take appropriate
steps to resolve
flag status.
3. Contact Hologic
Technical
Support.

261.000.00018 {0} flag assigned to An assay 1. See Appendix B.

Calibrator ID {1} for processing error Processing Flags
{2} assay in rack occurred with a on page 272 for
{3}. calibrator that has explanation.
been removed from
the instrument. 2. Take appropriate
steps to resolve
flag status.
3. Contact Hologic
Technical
Support.

261.000.00022 MTU count reached The MTU count has Load additional MTUs
the warning level. dropped below the into the Input Queue at
warning level. the next available
opportunity.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
261.000.00023 Assay {0}:{1} Name A software issue 1. Collect logs using
{2} version {3} occurred while the Send Logs
cannot be used. loading the assay feature (see Send
The RTF modules listed in the Logs on page
required by this message. 259).
assay may not be
installed or 2. Contact Hologic
enabled. Technical
Support.

261.001.00009 Liquid level The system This is an informational

detected in reagent detected that the message indicating the
'{0}' from carousel fluid volume in the fluid volume was
quadrant {1} / reagent bottle is adjusted. Ensure
position {2} is lower much lower than proper procedures are
than expected. Test expected. The being followed during
counts have been volume has been reagent preparation.
adjusted to match adjusted by the
the volume of the system. The issue
reagent. could be due to one
of the following:
1. Spillage or
removal of fluid
during bubble
pop.
2. Used kit being
loaded onto the
system for the
first time.
262.000.00002 There are not Fewer than the 1. Load additional
sufficient MTUs minimum number of MTUs and retry.
loaded for required MTUs are 2. If the problem
processing. in the Input Queue. persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.000.00003 There are not Fewer than the 1. Load additional
sufficient Tips minimum number of Tips.
loaded for required Tips are in 2. If the problem
processing all tests. the Tip Tray. persists, contact
Processing on new Hologic Technical
MTUs cannot Support.
continue until
additional Tips are
loaded.

262.000.00004 Could not calculate System or Assay 1. Shutdown and

the necessary software error. restart.
number of tips 2. If the problem
because the assay persists, contact
description or Hologic Technical
process steps were Support.
not found.

262.000.00005 Volume for liquid There is not enough 1. Empty the waste
waste is not remaining waste when in the Setup
sufficient for capacity to process or Ready states.
processing all tests. all tests. 2. If currently assay
Necessary tests = processing, wait
{0}, available tests until processing is
= {1}. done before
attempting to empty
the waste.
3. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.000.00006 Volume for solid There is not enough 1. Empty the waste
waste is not remaining waste when in the Setup
sufficient for capacity to process or Ready states.
processing all tests. all tests. 2. If currently assay
Necessary tests = processing, wait
{0}, available tests until processing is
= {1}. done before
attempting to empty
the waste.
3. If the problem
persists, contact
Hologic Technical
Support.
262.000.00009 The input queue is MTUs count 1. Load additional
empty. Please load reached zero. MTUs.
MTUs. Further sample 2. If the problem
pipetting will be persists, contact
delayed until Hologic Technical
additional MTUs Support.
are loaded.

262.000.00010 The reagent bottle ' The issue could be 1. Check volume of
{0}' in lane {1} due to one of the reagents prior to
position {2} is following: loading.
invalid after {3} 2. Allow processing to
consecutive LLD l Reagent pipettor
hardware or continue, as
failures. necessary.
calibration error.
l Not enough 3. Shut down and
volume in the restart once the
reagent bottle. Shutdown button is
available on the
Logoff/Shutdown
screen.
4. Contact Hologic
Technical Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.000.00012 The {0} reagent in The reagents Load additional valid
lane {1} has specified have reagent kits as
expired. reached their necessary.
expiration.

262.000.00015 The {0} reagent kit Assay reagent kit in Load a new assay
in lane {1} has the identified lane reagent kit to continue
expired. has expired. assay processing
following kit expiration.

262.000.00016 The pipettor System software 1. Shutdown and

coordinates for error. restart.
reagent kit {0} in 2. If the problem
lane {1} could not persists, contact
be retrieved or Hologic Technical
downloaded. The Support.
kit cannot be used.

262.000.00017 The pipettor System software 1. Shutdown and

coordinates for error. restart.
TCR/M in quadrant 2. If the problem
{0} could not be persists, contact
retrieved. The kit in Hologic Technical
lane {1} cannot be Support.
used.

262.000.00018 The fill level System software or 1. Shutdown and

parameters for database integrity restart.
reagent kit {0} in error. 2. If the problem
lane {1} could not persists, contact
be retrieved or Hologic Technical
downloaded. The Support.
kit cannot be used.

262.000.00021 Could not create System software 1. Shutdown and

the coordinate error. restart.
driver. Please 2. If the problem
check if persists, contact
'coordinate.coo' file Hologic Technical
is present! Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.000.00025 The universal fluid Identified fluid kit Replace with a new
{0} has expired. has expired and fluids kit when the
can no longer be system is in the Setup
used. The fluid or Ready state.
inventory is now
invalid.

262.000.00028 Auto Detect 1 A The system 1. Check the bottle

bottle is empty or detected air in the and the connection
not connected. fluid line. The bottle when in the Setup
Please check bottle is empty or not or Ready state.
connection connected. 2. If the problem
persists, contact
Hologic Technical
Support.
262.000.00029 Auto Detect 1 B The system 1. Check the bottle
bottle is empty or detected air in the and the connection
not connected. fluid line. The bottle when in the Setup
Please check bottle is empty or not or Ready state.
connection connected. 2. If the problem
persists, contact
Hologic Technical
Support.
262.000.00030 Auto Detect 2 A The system 1. Check the bottle
bottle is empty or detected air in the and the connection
not connected. fluid line. The bottle when in the Setup
Please check bottle is empty or not or Ready state.
connection connected. 2. If the problem
persists, contact
Hologic Technical
Support.
262.000.00031 Auto Detect 2 B The system 1. Check the bottle
bottle is empty or detected air in the and the connection
not connected. fluid line. The bottle when in the Setup
Please check bottle is empty or not or Ready state.
connection connected. 2. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.000.00032 Wash Buffer A The system 1. Check the bottle
bottle is empty or detected air in the and the connection
not connected. fluid line. The bottle when in the Setup
Please check bottle is empty or not or Ready state.
connection connected. 2. If the problem
persists, contact
Hologic Technical
Support.
262.000.00033 Wash Buffer B The system 1. Check the bottle
bottle is empty or detected air in the and the connection
not connected. fluid line. The bottle when in the Setup
Please check bottle is empty or not or Ready state.
connection connected. 2. If the problem
persists, contact
Hologic Technical
Support.
262.000.00034 Deactivation Buffer The system 1. Check the bottle
A bottle is empty or detected air in the and the connection
not connected. fluid line. The bottle when in the Setup
Please check bottle is empty or not or Ready state.
connection connected. 2. If the problem
persists, contact
Hologic Technical
Support.
262.000.00035 Deactivation Buffer The system 1. Check the bottle
B bottle is empty or detected air in the and the connection
not connected. fluid line. The bottle when in the Setup
Please check bottle is empty or not or Ready state.
connection connected. 2. If the problem
persists, contact
Hologic Technical
Support.
262.000.00036 Bleach bottle is The system 1. Check the bottle
empty or not detected air in the and the connection
connected. Please fluid line. The bottle when in the Setup
check bottle is empty or not or Ready state.
connection connected. 2. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.000.00038 Could not retrieve System software or 1. Shutdown and
pipettor coordinates database error. restart.
for sample rack 2. If the problem
type '{0}' from lane persists, contact
{1}. The Hologic Technical
coordinates file '{2}' Support.
was not found.
Please check if the
file is on disk or
check the
association
[racktype,filename]
from the Panther
settings file.

262.000.00039 Unknown sample System software or 1. Shutdown and

rack type ‘{0}’ in database error. restart.
lane {1} or type not 2. If the problem
supported. persists, contact
Hologic Technical
Support.
262.000.00042 The liquid waste is Further processing 1. Open the Waste
full. is not possible once Drawer and check
the sensor on the the status of the
Liquid Waste Bottle waste bottle.
is reporting as full. 2. If the bottle is full,
empty both waste
containers.
3. If the bottle is not
full, contact Hologic
Technical Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.000.00043 The volume in the The issue could be 1. Ensure there are
Target Capture due to one of the no bubbles or
Reagent bottle in following: foam present in
quadrant {0} is the TCR.
higher than 1. Foam or
expected. Please bubbles can 2. Ensure the TCR
ensure bottle is cause the bottle is fully
seated down system to detect seated.
properly and no a higher than
expected fluid 3. If the problem
foam or bubbles are persists, contact
present. level.
Hologic
2. The bottle not Technical
being fully Support.
seated in the
TCR carousel.
262.000.00044 The volume in the During reagent 1. Ensure the bottle
Target Capture aspiration, the is not pushed all
Reagent bottle in volume from the the way down.
quadrant {0} is database doesn't
lower than match with the 2. Contact Hologic
expected. Assay kit volume detected in Technical
will not be used to the bottle. Support.
pipette samples.

262.000.00045 The master lot Identified reagent kit 1. Replace the

associated with the has expired and affected kit with a
reagent kit from can no longer be reagent kit from a
lane {0} has used. All assay valid mater lot.
expired. The kit is reagent kits with 2. If the problem
invalid. this same master lot persists, contact
number can no Hologic Technical
longer be used. Support.
262.000.00049 MTU count reached Warning level for Load additional MTUs.
the warning level. MTU count has
been reached. 25
MTU tests or less in
the input queue.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.000.00050 Tip count reached Warning level for 1. Load additional
the warning level. Tip count has been tips.
reached. 96 tips or 2. Do not allow the tip
less remaining. count to reach 0 or
assay processing
will be terminated.
262.000.00054 Undeactivated Deactivation Fluid Contact Hologic
Waste may be Dispense Technical Support.
present in liquid Verification error.
and solid waste
containers. Please
CALL TECHNICAL
SUPPORT for
instructions.

262.000.00055 Incubators warm-up Indicates to the No action necessary.

completed. operator that the
incubators have
reached their
operating
temperature.

262.001.00007 Liquid level An old reagent kit Use a new reagent kit.
detected in reagent was used.
'{0}' from carousel
quadrant {1} /
position {2} is lower
than expected. Test
counts have been
adjusted to match
the volume of the
reagent.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.001.00010 The reagent bottle ' The issue could be 1. Check volume of
{0}' in lane {1} due to one of the reagents prior to
position {2} is following: loading.
invalid after {3} 2. Allow processing to
consecutive RDV l Reagent pipettor
hardware or continue, as
failures. necessary.
calibration error.
l Not enough 3. Shut down and
volume in the restart once the
reagent bottle. Shutdown button is
available on the
Logoff/Shutdown
screen.
4. Contact Hologic
Technical Support.
262.002.00007 Liquid level Possible fluid issue. Use a new reagent kit.
detected in reagent
'{0}' is lower than
expected. Test
counts have been
adjusted to match
the volume of the
reagent.

262.002.00010 The reagent bottle ' The issue could be 1. Check volume of
{0}' in quadrant {1} due to one of the reagents prior to
is invalid after {2} following: loading.
consecutive LLD 2. Allow processing to
failures. l Sample pipettor
hardware or continue, as
calibration error. necessary.
l Not enough 3. Shut down and
volume in the restart once the
reagent bottle. Shutdown button is
available on the
Logoff/Shutdown
screen.
4. Contact Hologic
Technical Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
262.003.00010 The reagent bottle ' The issue could be 1. Check volume of
{0}' in quadrant {1} due to one of the reagents prior to
is invalid after {2} following: loading.
consecutive RDV 2. Allow processing to
failures. l Sample pipettor
hardware or continue, as
calibration error. necessary.
l Not enough 3. Shut down and
volume in the restart once the
reagent bottle. Shutdown button is
available on the
Logoff/Shutdown
screen.
4. Contact Hologic
Technical Support.
263.001.00001 The instrument System software or 1. Collect logs using
reported a fatal hardware error. the Send Logs
timeout. feature (see Send
Logs on page
259).
2. Contact Hologic
Technical
Support.

263.001.00002 The instrument System software or 1. Collect logs using

reported an error. hardware error. the Send Logs
feature (see Send
Logs on page
259).
2. Contact Hologic
Technical
Support.

267.001.00001 Panther Dashboard N/A No action necessary.

Data Storage
service is not
started.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
267.001.00002 An error has System software 1. Shutdown and
occurred writing to error. restart.
the Panther 2. Contact Hologic
Dashboard Data Technical Support.
Software queue.

267.001.00003 Drive space getting Computer hard 1. Configure the

exhausted. drive space is system to purge all
Currently {0}% drive approaching the system logs over
space used. maximum limit. two (2) months old.
2. Shutdown and
restart.
3. Contact Hologic
Technical Support.
267.001.00004 Drive space getting Computer hard 1. Configure the
exhausted. drive space is system to purge all
Currently {0}% drive approaching the system logs over
space used. maximum limit. two (2) months old.
System will be 2. Shutdown and
stopped next time if restart.
more then {1}% are 3. Contact Hologic
used. Technical Support.
267.001.00005 Drive space is Drive space is Contact Hologic
exhausted. System exhausted. Technical Support.
is stopped.

269.000.00001 Fatal software System software 1. Shutdown and

exception occurred. error. restart.
Transitioning to 2. If the problem
error state. persists, contact
Hologic Technical
Support.
269.000.00002 Communication The software and 1. Shutdown and
with the instrument hardware were restart.
was lost. Shut disconnected. 2. If the problem
down and restart persists, contact
the software. Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
269.000.00003 Instrument The software and 1. Shutdown the
response delay. hardware were software and
disconnected or the ensure that the
software was hardware is
started with the powered on.
instrument powered 2. Wait 20 seconds
down. after powering on
the hardware before
selecting Panther
on the Desktop
Shield.
3. If the problem
persists, contact
Hologic Technical
Support.
269.000.00005 A fatal error was System software or 1. Shutdown and
reported by the hardware failure. restart.
instrument. 2. Contact Hologic
Technical Support.
269.000.00006 A fatal error was System software or 1. Shutdown and
reported by the hardware failure. restart.
instrument. Current 2. Contact Hologic
operation will be Technical Support.
aborted.

269.000.00008 Software exception System software 1. Collect logs using

occurred error. the Send Logs
feature (see Send
Logs on page
259).
2. Contact Hologic
Technical
Support.

271.000.00002 Imported assay {0} N/A No action necessary.

(Name={1}) from file
{2}.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
271.000.00003 Assay {0} not System software or 1. Shutdown and
loaded from file {1}. hardware failure. restart.
CRC mismatch. 2. Contact Hologic
Technical Support.

271.000.00004 Assay from file {0} Database integrity 1. Shutdown and

not loaded. check failure. restart.
Deserialization did 2. Contact Hologic
not work or the Technical Support.
description is
empty.

271.005.00002 Assay {0}:{1} A software issue 1. Collect logs using

(Name {2} File {3}) occurred while the Send Logs
version {4} not loading the assay feature (see Send
loaded. No process listed in the Logs on page
steps present. message. 259).

2. Contact Hologic
Technical
Support.

271.005.00003 Multiple assay files A software issue 1. Collect logs using

detected for assay occurred while the Send Logs
type {0}. Assays not loading the assay feature (see Send
loaded. listed in the Logs on page
message. 259).
2. Contact Hologic
Technical
Support.

271.005.00004 Assay {0}:{1} A software issue 1. Collect logs using

(Name {2} File {3}) occurred while the Send Logs
version {4} not loading the assay feature (see Send
loaded. Assay is listed in the Logs on page
already present message. 259).
with different
content. 2. Contact Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
271.005.00005 Assay file {0} Requested assays 1. Collect logs using
cannot be loaded. are not present or the Send Logs
File is corrupted or enabled. feature (see Send
mandatory Logs on page
elements are 259).
missing.
2. Contact Hologic
Technical
Support.

271.005.00006 Assay file {0} Corruption of assay Re-install assay

cannot be loaded, installation or software package.
associated thermal workstation
profile is missing. directory.

271.005.00007 Assay file {0} Corruption of assay Re-install assay

cannot be loaded, installation or software package.
associated frontend workstation
assay is missing. directory.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
272.000.00001 The sample ID from The number of 1. If the barcode is
lane {0} positions characters in the greater than 20
{1} exceeded the Sample ID is characters, use a
maximum number greater than 20 new barcode or
of characters in the characters. The manually enter the
barcode. allowable barcode SID on the Sample
range is 4–20 Rack Loading
characters. screen.
2. If the barcode is
within the character
range, reload the
sample to rescan.
3. Contact Hologic
Technical Support.
272.000.00002 LIS: Cannot N/A No action necessary.
establish
connection.

272.000.00003 LIS: The The result does not 1. Change LIS

connection to the meet the criteria for configuration
host was lost. transfer to LIS. settings as needed.
2. If the problem
persists, contact
Hologic Technical
Support.
272.000.00005 Structure of The LIS server sent 1. Enable the ASTM
message received an incorrectly 1381 and ASTM
from LIS was formatted message 1394 logging in the
incorrect. to the Panther LIS configuration.
system. 2. Retry attempt to
send test orders.
3. Contact LIS vendor
for assistance.
4. If additional
assistance is
required or the
problem persists,
contact Hologic
Technical Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
272.000.00006 Error while Failed network 1. Enable the ASTM
transmitting data to connection or LIS 1381 and ASTM
LIS. server error. 1394 logging in the
LIS configuration.
2. Retry attempt to
send test orders.
3. Ensure instrument
TCP/IP or RS232
connection is
functional.
4. If additional
assistance is
required or the
problem persists,
contact Hologic
Technical Support.
272.000.00007 Pending results A transmission error Follow the prompt to
automatically occurred when either attempt to re-
removed from the sending results. transmit or remove from
queue after the transmission
transmission error. queue.
1. Enable the ASTM
1381 and ASTM
1394 logging in the
LIS configuration.
2. Inspect the
transmission
column in the
Results tab and
retry the attempt to
transmit results
which did not
transmit.
3. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
272.000.00008 LIS: System not Host query option is Enable Host Query
configured to not enabled. Responding in the LIS
respond to query for Configuration located
results. under the
Administration screen.

272.000.00009 Test Order for Repeat detection is Manually override by

Sample ID {0} lane enabled. The navigating to the
{1} position {2}, system attempted to Sample Loading
assay {3}, analytes create the test order screen and inspecting
{4} was detected a and determined that the sample details.
repeat. Test Order it was a repeat.
was not created.

272.000.00010 {0} in sample rack System software 1. Collect logs using

{1}, position {2} error. the Send Logs
does not match feature (see Send
master lot of a Logs on page
loaded assay 259).
reagent kit.
2. Backup the
database.
3. Contact Hologic
Technical
Support.

272.000.00011 {0} in sample rack System software 1. Collect logs using

{1}, position {2} is error. the Send Logs
not part of a feature (see Send
registered calibrator Logs on page
master lot. 259).
2. Backup the
database.
3. Contact Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
272.000.00012 {0} in sample rack System software 1. Collect logs using
{1}, position {2} has error. the Send Logs
not been registered. feature (see Send
Logs on page
259).
2. Backup the
database.
3. Contact Hologic
Technical
Support.

272.000.00013 No Calibrator System software 1. Collect logs using

Masterlot found for error. the Send Logs
assay {0}. feature (see Send
Logs on page
259).
2. Backup the
database.
3. Contact Hologic
Technical
Support.

272.000.00014 No Control System software 1. Collect logs using

Masterlot found for error. the Send Logs
assay {0}. feature (see Send
Logs on page
259).
2. Backup the
database.
3. Contact Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
272.000.00015 {0} in sample rack System software 1. Collect logs using
{1}, position {2} error. the Send Logs
does not match feature (see Send
master lot of a Logs on page
loaded assay 259).
reagent kit.
2. Backup the
database.
3. Contact Hologic
Technical
Support.

272.000.00016 New LIS Test Order The system 1. Manually add the
for Sample ID {0} attempted to create test order by
lane {1} position {2}, the test order and inspecting the
assay {3}, analytes determined that it Sample Details in
{4} was detected as was a repeat. the Sample
a repeat of a test Loading screen.
order in the state:
{5}. 2. Contact Hologic
Technical
Support.

272.000.00018 Existing LIS Test The system 1. Manually add the

Order for Sample ID attempted to create test order by
{0} lane {1} position the test order and inspecting the
{2}, assay {3}, determined that it Sample Details in
analytes {4} was was a repeat. the Sample
detected as a Loading screen.
repeat of a test
order in the state: 2. Contact Hologic
{5}. Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
272.000.00019 LIS order for The assay being 1. Enable the ASTM
sample {0} rejected. requested by the 1381 and ASTM
Requested assay LIS system does not 1394 logging in
does not support support the dilution the LIS
the requested factor sent with the configuration.
dilution. test order.
2. Retry attempt to
send test orders.
3. Contact Hologic
Technical
Support.

272.000.00020 LIS order for A test order exists in 1. Enable the ASTM
sample {0} rejected. the system 1381 and ASTM
Test order is not database with the 1394 logging in
compatible with different dilution the LIS
existing sample factor than what configuration.
dilution. was sent by the LIS
system. 2. Retry attempt to
send test orders.
3. If the problem
persists, preform
a database
backup when
available and
contact Hologic
Technical
Support.

272.000.00021 Reflex test {0} A reflex text was No action necessary.

created for sample created for the
{1}. indicated sample.

272.000.00022 Sample {0} is A reflex test was Reload the specified

scheduled for reflex created for the sample.
{1} testing, but indicated sample
sample is no longer however, it has
on-board the been removed from
instrument. Please the system.
reload sample.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
272.000.00023 LIS order for An LIS test order 1. Consult the LIS
sample {0} rejected. was received with a Host Guide and
LIS test orders that dilution factor set for ensure the
include dilution the test order. Dilution factor
factors are not sub-field is
accepted by the correctly set to
system. one. Assistance
from your LIS
vendor may be
required.
2. If additional
assistance is
needed, contact
Hologic
Technical
Support.

272.000.00024 Error while An error occurred 1. Enable the ASTM

receiving data from while receiving data 1381 and ASTM
LIS. from the LIS system. 1394 logging in
the LIS
configuration.
2. Retry attempt to
send test orders.
3. Contact LIS
vendor for
assistance
4. Contact Hologic
Technical
Support if
additional
assistance is
required.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
272.000.00025 Reflex test {0} for An attempt was 1. See Appendix B.
SID {1} was not made to create a Processing Flags
created as the reflex test for a on page 272 for
sample is invalid. sample which was explanation.
Invalidity reason: previously tested as
{2} invalid. 2. Take appropriate
steps to resolve
flag status.
3. Contact Hologic
Technical
Support.

272.000.00026 Test Order for A sample rack was Put retainer on the
Sample ID {0} lane loaded without the sample rack and reload
{1} position {2}, sample rack the rack.
assay {3} requires a retainer.
rack retainer.
Please add retainer
to rack and reload
the rack.

272.000.00027 Reflex test {0} for An attempt was 1. See Appendix B.

SID {1} was not made to create a Processing Flags
created as the reflex test for a on page 272 for
sample is invalid. sample which was explanation.
Invalidity reason: previously tested as
{2} invalid. 2. Take appropriate
steps to resolve
flag status.
3. Contact Hologic
Technical
Support.

272.000.00028 Test Order for A sample rack was Put retainer on the
Sample ID {0} lane loaded without the sample rack and reload
{1} position {2}, sample rack the rack.
assay {3} requires a retainer.
rack retainer.
Please add retainer
to rack and reload
the rack.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
272.000.00029 LIS transmission User cancelled LIS 1. If cancellation was
terminated by user. during transmission. intentional, select
Save after altering
the LIS
configurations.
2. If cancellation was
not intentional,
enable LIS
connection (see
Enable LIS
Connection on
page 237).
277.000.00000 Scanning cannot The issue could be 1. Firmly close the
be started while the due to one of the TCR Carousel
door is open or following: loading door.
unlocked. 2. If the problem
l The TCR
Carousel persists, contact
loading door is Hologic Technical
open. Support.
l Sensor is not
functioning
properly.
282.000.00002 The {0} reagent has The reagent Load a new reagent to
expired. identified has continue assay
expired. processing.

283.000.00001 Invalidated Sample See accompanying 1. Correct any flags.

ID {1} for {2} assay message(s) to 2. Re-load and retest
in lane {3} position determine cause. all affected
{4} due to {0} flag. All in-process samples.
Sample will need to samples will be 3. If the problem
be retested. invalidated. persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
283.000.00002 Invalidated Sample See accompanying 1. Correct any flags.
ID {1} for {2} assay message(s) to 2. Re-load and retest
in rack {3} due to {0} determine cause. all affected
flag. Sample will All in-process samples.
need to be retested. samples will be 3. If the problem
invalidated. persists, contact
Hologic Technical
Support.
283.000.00003 {0} flag assigned to See accompanying 1. Correct any flags
Sample ID {1} for message(s) to and continue.
{2} assay in lane {3} determine cause. 2. If the problem
position {4}. persists, contact
Hologic Technical
Support.
283.000.00004 {0} flag assigned to See accompanying 1. Correct any flags
Calibrator ID {1} for message(s) to and continue.
{2} assay in lane {3} determine cause. 2. If the problem
position {4}. persists, contact
Hologic Technical
Support.
283.000.00005 {0} flag assigned to See accompanying 1. Correct any flags
Control ID {1} for {2} message(s) to and continue.
assay in lane {3} determine cause. 2. If the problem
position {4}. persists, contact
Hologic Technical
Support.
283.000.00006 {0} flag assigned to See accompanying 1. Correct any flags
Sample ID {1} for message(s) to and continue.
{2} assay in rack determine cause. 2. If the problem
{3}. persists, contact
Hologic Technical
Support.
283.000.00007 {0} flag assigned to See accompanying 1. Correct any flags
Calibrator ID {1} for message(s) to and continue.
{2} assay in rack determine cause. 2. If the problem
{3}. persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
283.000.00012 Assay {0}:{1} Name System software Contact Hologic
{2} version {3} not error. Technical Support.
loaded. Problems
detected while
loading the
associated DLL.

283.000.00013 Assay {0}:{1} Name System software Contact Hologic

{2} version {3} error. Technical Support.
cannot be used.
Problems detected
when the system
attempted to load
the Assay.

356.000.00002 The assay System software or 1. Shutdown and

assembly returned database error. restart.
an invalid value. 2. Contact Hologic
Technical Support.
356.000.00003 Too many System software or 1. If the error is
replicates of the database error. persistent, shut
same level down and restart
detected in a set. when in the Setup,
Ready or Error
states.
2. Contact Hologic
Technical Support.
356.000.00004 An assay assembly System software or 1. Shutdown and
failed to load. database error. restart.
2. Contact Hologic
Technical Support.
356.000.00006 Error when System software 1. Shutdown and
mapping flags. error. restart.
Please contact 2. Contact Hologic
technical support. Technical Support.
406.001.00001 Software exception System software 1. Shutdown and
occurred error. restart.
2. Contact Hologic
Technical Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00004 Missing help Help window link is 1. Navigate to another
directory {0} invalid. screen location and
select Help to
connect to the Help
window.
2. If the problem
persists, contact
Hologic Technical
Support.
406.001.00005 Missing help file {0} Help window link is 1. Navigate to another
invalid. screen location and
select Help to
connect to the Help
window.
2. If the problem
persists, contact
Hologic Technical
Support.
406.001.00006 Printer Printer configuration 1. Ensure that the
configuration does incomplete or printer is properly
not match system incorrect. connected and that
default printer {0} the Printer settings
on the System
Configuration
screen are correct.
2. If the problem
persists, contact
Hologic Technical
Support.
406.001.00008 Default printer {0} is Printer configuration 1. Ensure that the
not set up incomplete or printer is properly
incorrect. connected and that
the Printer settings
on the System
Configuration
screen are correct.
2. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00010 Printer {0} is not No printer installed. No action necessary.
installed

406.001.00011 Failed to set up Printer configuration 1. Ensure that the

default printer {0} incomplete or printer is properly
incorrect. connected and that
the Printer settings
on the System
Configuration
screen are correct.
2. If the problem
persists, contact
Hologic Technical
Support.
406.001.00012 Result ID: ({0}) Database integrity 1. Shutdown and
failed its CRC check failure. restart.
check and will not 2. Contact Hologic
be displayed. Technical Support.

406.001.00013 {0} results were not Database integrity 1. Shutdown and

exported due to check failure. restart.
CRC check 2. Contact Hologic
failures. IDs: ({1}) Technical Support.

406.001.00015 Failed to export Message generated If the problem persists,

report. Reason: {0} as appropriate for contact Hologic
failure. Check Technical Support.
accompanying
messages if
available.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00016 Assay Reagent Kit Master Lot not 1. Unload the affected
ID:{0} (Assay: {1}) is entered prior to Reagent Rack and
valid but does not loading kit. enter the Master Lot
have a MasterLot information through
assigned to it. the Assay Reagent
Bay screen.
2. Reload the
Reagent Rack once
the Master Lot
information has
been properly
entered.
406.001.00017 The following result Database integrity 1. Shutdown and
IDs failed CRC check failure. restart.
check and were not 2. If the problem
displayed in the persists, contact
report: {0} Hologic Technical
Support.
406.001.00018 Could not display System software or Contact Hologic
{0} results because database error. Technical Support.
unknown assay '{1}'
was used to
process them

406.001.00022 Maintenance task ' Required Complete Maintenance

{0}' overdue maintenance task is task when in the Setup
overdue. The state.
system is not able
to transition into the
Ready or Assay
Processing state
until the task has
been completed.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00023 Maintenance task ' Required Complete Maintenance
{0}' is due on {1}. maintenance task is task when in the Setup
due in the time cited or Ready state.
in the message.
The system is not
able to transition
into the Ready or
Assay Processing
state until the task
has been
completed.

406.001.00025 Failed to merge old System software or 1. Shutdown and

configuration database error. restart.
settings. 2. Contact Hologic
Technical Support.
406.001.00026 Value was out of Parameter setting is 1. Reconfigure value
range for out of range. to specified
configuration configuration
setting {0} - {1}. setting.
Please reconfigure 2. If the problem
it. persists, contact
Hologic Technical
Support.
406.001.00027 Configuration System software or 1. Shutdown and
setting file {0} is database error. restart.
invalid or corrupted 2. Contact Hologic
Technical Support.
406.001.00028 Maintenance task ' Maintenance task 1. If possible, correct
{0}' did not auto- did not start at the the cause of the
start. Task is now scheduled time. task failure listed in
rescheduled to {1}. Check associated the accompanying
messages for message.
reason the task 2. Retry maintenance
failed to start. task.
3. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00029 Sample Loading N/A No action necessary.
defaults set: Assay
{0} Analytes {1}

406.001.00030 Sample Loading N/A No action necessary.

defaults set:
Replicates {0}

406.001.00031 Required The required 1. Complete

maintenance is maintenance task Maintenance task
suppressed until has been when in the Setup
{0}. rescheduled. The or Ready state.
system is not able 2. If the problem
to transition into the persists, contact
Ready or Assay Hologic Technical
Processing state Support.
until the task has
been completed.

406.001.00032 Required The required 1. Complete

maintenance is maintenance task Maintenance task
suppressed until has been when in the Setup
{0}. rescheduled. The or Ready state.
system is not able 2. If the problem
to transition into the persists, contact
Ready or Assay Hologic Technical
Processing state Support.
until the task has
been completed.

406.001.00033 Required N/A No action necessary.

maintenance is
now enabled.

406.001.00034 Required An FSE disabled No action necessary.

maintenance is the required
now enabled. maintenance and it
is now re-enabled.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00035 LIS Export Error: The issue could be 1. Ensure
Unauthorized due to one of the configuration
Access following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00037 LIS Export Error: The issue could be 1. Ensure
Security Exception due to one of the configuration
following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00039 LIS Export Error: The issue could be 1. Ensure
Directory Not due to one of the configuration
Found following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00041 LIS Export Error: IO The issue could be 1. Ensure
Exception due to one of the configuration
following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00043 LIS Export Error: The issue could be 1. Ensure
Path Too Long due to one of the configuration
following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00045 Raw Data Export The issue could be 1. Ensure
Error: Unauthorized due to one of the configuration
Access following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00047 Raw Data Export The issue could be 1. Ensure
Error: Security due to one of the configuration
Exception following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00049 Raw Data Export The issue could be 1. Ensure
Error: Directory Not due to one of the configuration
Found following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00051 Raw Data Export The issue could be 1. Ensure
Error: IO Exception due to one of the configuration
following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00053 Raw Data Export The issue could be 1. Ensure
Error: Path Too due to one of the configuration
Long following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00055 Stream Error: The issue could be 1. Ensure
Unauthorized due to one of the configuration
Access following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00057 Stream Error: The issue could be 1. Ensure
Security Exception due to one of the configuration
following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00059 Stream Error: The issue could be 1. Ensure
Directory Not due to one of the configuration
Found following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00061 Stream Error: IO The issue could be 1. Ensure
Exception due to one of the configuration
following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00063 Stream Error: Path The issue could be 1. Ensure
Too Long due to one of the configuration
following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00065 LIS Export Error: The issue could be 1. Ensure
Failed to create LIS due to one of the configuration
export. following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00067 Failed to start LIS The issue could be 1. Ensure
connection. due to one of the configuration
following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00068 Failed to stop LIS The issue could be 1. Ensure
connection. due to one of the configuration
following: settings are correct.
l LIS 2. Contact LIS system
Configuration administrator to
Issue. check LIS host
communications
l System and background
Software error. tasks.
l LIS error. 3. Refer to the Panther
LIS Host Interface
Guide for additional
troubleshooting.
4. If the problem
persists, contact
Hologic Technical
Support.
406.001.00069 Dashboard failed to System software 1. Shutdown and
start. error. restart.
2. Contact Hologic
Technical Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00071 Failed maintenance A maintenance task No action necessary.
task "{0}" will be has failed.
rescheduled to run
at it's next available
time.

406.001.00072 User Settings Error: A setting in the User Collect logs using the
{0} Settings has an Send Logs feature (see
error. Send Logs on page
259).

406.001.00073 Maintenance task Maintenance task 1. If possible, correct

{0} failed due to: {1} failed. Check the cause of the
accompanying task failure listed.
messages for 2. Retry maintenance
additional causes of task.
the failure. 3. If the problem
persists, contact
Hologic Technical
Support.
406.001.00074 Maintenance task ' A maintenance task No action necessary.
{0}' is due in {1} is due in specified
cycles. amount of cycles.

406.001.00075 Unable to register N/A No action necessary.

for printer events.
Printer status will
not be available.

406.001.00076 Maintenance task ' A maintenance task No action necessary.

{0}' started was initiated.

406.001.00077 Maintenance task ' A maintenance task No action necessary.

{0}' completed completed
successfully successfully.

406.001.00078 Maintenance task ' A maintenance task Retry maintenance task

{0}' failed has failed. if needed.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00079 Failed to export raw Failed to export raw 1. Retry export.
data, reason: {0} data because there 2. Check USB flash
was a problem with drive for damage.
USB drive or a 3. Replace USB flash
problem with drive, if necessary.
copying to USB
drive. 4. If the problem
persists, collect
logs using the Send
Logs feature (see
Send Logs on page
259).
406.001.00080 Failed to export LIS Occurs when the 1. Retry export.
data, reason: {0} operator has 2. Check USB flash
selected the Export drive for damage.
LIS Data button on 3. Replace USB flash
the Results screen drive, if necessary.
and there is error
with the export. 4. If the problem
persists, collect
logs using the Send
Logs feature (see
Send Logs on page
259).
406.001.00081 Failed to print Report was not 1. Retry Print
report, reason: {0} printed. command.
2. Check printer for
errors.
3. Collect logs using
the Send Logs
feature (see Send
Logs on page 259).
406.001.00082 Failed to create Report was not 1. Retry View
report for viewing, created. command.
reason: {0} 2. Collect logs using
the Send Logs
feature (see Send
Logs on page 259).

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00084 Report export The specified 1. Retry export.
canceled due to export path is not 2. Collect logs using
directory path error accessible. the Send Logs
feature (see Send
Logs on page 259).
406.001.00085 Hardware keyboard The system detects 1. Unplug external
issue detected. the keyboard is keyboard.
Please unplug pressed repeatedly.
keyboard from PC. 2. Check for stuck
Contact Service keys, liquid
Support for dropped on
additional keyboard, or
assistance. other damages.
3. If the problem
persists, contact
Hologic
Technical
Support.

406.001.00087 Error encountered Error reading or Collect logs using the

on directory {0} writing directory. Send Logs feature (see
Send Logs on page
259).

406.001.00088 Unable to find The directory does Collect logs using the
directory {0} not exist. Send Logs feature (see
Send Logs on page
259).

406.001.00089 Network access Cannot access 1. Contact local

error network drives. technical support
and check for
network issues or
unexpected
changes in
network
configuration.
2. If the problem
persists, contact
Hologic
Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.001.00090 Failed to load The report template Collect logs using the
report helper, file was not found in Send Logs feature (see
unable to find the Report Send Logs on page
template file: {0} Manager. 259).

406.001.00091 Failed to export Failed to copy Viral 1. Retry export.

viral load Load intermediate 2. Check USB flash
intermediate results data to the USB drive for damage.
data, reason: {0} drive. 3. Replace USB flash
drive, if necessary.
4. If the problem
persists, collect
logs using the Send
Logs feature (see
Send Logs on page
259).
406.001.00092 Failed to print File does not exist 1. Retry Print
report. Please or there was a command.
check printer printer problem. 2. Check printer for
hardware and errors.
printer 3. Collect logs using
configuration. the Send Logs
feature (see Send
Logs on page 259).
406.001.00093 Existing Reflex The existing Reflex 1. Review Reflex
Testing Testing configuration to
configuration does configuration does ensure the correct
not match with not match with the assays have
installed assays. assays installed in been installed.
Please reconfigure the system.
Reflex Testing. 2. Contact Hologic
Technical
Support.

406.001.00095 LIS: There are {0} Informational Export LIS data when it
results pending message is convenient.
transmission. concerning the
amount of LIS
exports waiting to
be sent.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
406.002.00001 Database restored N/A No action necessary.
from backup {0}

407.001.00001 User logged on N/A No action necessary.

407.001.00002 User logged off N/A No action necessary.

407.001.00003 User shutdown N/A No action necessary.

407.001.00004 User added: {0} N/A No action necessary.

407.001.00005 User edited: {0} N/A No action necessary.

407.001.00006 User deleted: {0} N/A No action necessary.

407.001.00007 User password N/A No action necessary.

changed

407.002.00001 Valid Assay N/A No action necessary.

Reagent Kit
Loaded: {0}

407.002.00002 Assay Reagent Kit N/A No action necessary.

Unloaded: {0}

407.002.00003 AR Inventory N/A No action necessary.

started

407.002.00005 Assay Reagent Kit Identified reagent kit Load a new assay
has expired in lane has expired and reagent kit to process
{0}. can no longer be additional tests.
used.

407.002.00006 Load/unload The system is ready 1. Load/unload

carousel reagents to load/unload reagents in the
and close carousel carousel reagents. carousel according
door to current task.
2. Close the TCR
Door completely
before continuing.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.002.00007 {0} cutoff set to {1} Supplemental No action necessary.
for {2} reagent kit in assay reagent
lane {3}. information has
been accepted. The
cutoff values for an
assay reagent kit
has been changed.

407.002.00008 {0} cutoff set to null N/A No action necessary.

for {1} reagent kit in
lane {2}.

407.003.00001 Universal Fluid Universal Fluid 1. Close the fluid

drawer opened drawer opened drawer.
during Assay during Assay 2. Do not open
Processing. Processing. Universal Fluid
drawer during
Assay Processing.
407.003.00002 Fluids Inventory N/A No action necessary.
started

407.003.00004 Data Integrity: Database Integrity 1. Close the fluid

Universal Fluid error. drawer.
bottles were 2. Contact Hologic
incorrectly marked Technical Support.
as loaded.

407.003.00005 Universal Fluid The Universal No action necessary.

drawer opened Fluids drawer is
during Priming. opened during
priming.

407.004.00001 Test Order added to N/A No action necessary.

Sample {0}: Assay
{1}

407.004.00002 Test Order on N/A No action necessary.

Sample {0}
updated: Sample
{1}, Analytes {2},
Priority {3}

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.004.00003 Test Order deleted N/A No action necessary.
from Sample {2}:
Assay {0}, Analytes
{1}

407.004.00004 Test Order Analytes Tried to change 1. Cannot remove test

cannot be changed Test order Analyte orders once the test
once Sample has type after sample order has already
been pipetted: was pipetted. been pipetted.
Sample {0}, Assay 2. Edit the test orders
{1}, Analytes {2}. for a specimen prior
to pipetting.
407.004.00005 Test Order for N/A No action necessary.
Sample {0} Verified

407.004.00006 Unable to resolve System software or 1. Shutdown and

assay for test order: database error. restart.
{0} - {1} 2. If the problem
persists, contact
Hologic Technical
Support.
407.004.00007 Attempted to Verify While verifying No action necessary.
a Test that was not each test order, a
complete: {0} - {1} : check is made to
{2} verify the test order
is completed.

407.005.00001 Waste Inventory N/A No action necessary.

started

407.005.00002 Waste drawer error. The Waste Drawer 1. Firmly close the
Please open and has failed to Waste Drawer.
close the waste properly lock. 2. If the problem
drawer. persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.005.00004 The Waste capacity The waste inventory 1. Empty the waste
has dropped below has dropped below when in the Setup
{0} tests. the listed number of or Ready state to
tests. refresh the Waste
inventory.
2. If the problem
persists, contact
Hologic Technical
Support.
407.005.00005 The Waste is full. The waste inventory 1. Empty the waste
has dropped below when in the Setup
the listed number of or Ready state to
tests. refresh the Waste
inventory.
2. If the problem
persists, contact
Hologic Technical
Support.
407.005.00006 The Liquid Waste The issue could be 1. The system is not
container was not due to one of the able to process
emptied. following: samples.
l The Liquid 2. Empty the waste
Waste when possible to
Container is full. refresh the Waste
inventory.
l The float sensor
3. Ensure that the float
on the Liquid
Waste sensor on the
Container has Liquid Waste
mistakenly Container is not
registered as stuck at the top of
full. the bottle.
4. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.005.00007 The Solid Waste The issue could be 1. The system is not
bag was not due to one of the able to process
emptied. following: samples.
1. The waste 2. Empty the waste
inventory has when possible to
been depleted. refresh the Waste
inventory.
2. Samples were
loaded when the 3. If samples were
Waste Drawer loaded when the
was open. Waste or Universal
Fluids Drawer was
open, close the
drawers and reload
the Sample Racks.
4. If the problem
persists, contact
Hologic Technical
Support.
407.005.00008 The Solid Waste The issue could be 1. Unlock and open
bag is not present. due to one of the the Waste Drawer
following: and ensure that the
liquid waste has
l Liquid Waste been emptied.
container was
not completely 2. Ensure that the float
emptied when sensor on the
emptying the Liquid Waste
waste. Container is not
stuck above the
l The float sensor bottom of the bottle.
on the Liquid
Waste 3. If the problem
Container is persists, contact
stuck above the Hologic Technical
bottom of the Support.
container.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.005.00009 Waste drawer The issue could be 1. Unlock and open
opened during due to one of the the Waste Drawer
Assay Processing. following: and ensure that the
solid waste has
l Solid Waste been emptied.
container was
not emptied 2. Ensure that the
when emptying diagram on the
the waste. monitor changed
from green-to-red-
l The sensor on to-green when
the Solid Waste changing the Waste
Container is Bag.
malfunctioning.
3. If the problem
persists, contact
Hologic Technical
Support.
407.006.00001 Rack Loaded: {0} N/A No action necessary.

407.006.00002 Rack Unloaded: {0} N/A No action necessary.

407.006.00003 Duplicate sample N/A No action necessary.

confirmed: {0}

407.006.00004 Sample Bay Sample Bay 1. Close the Sample

barcode scanner barcode scanner Bay door and load
was unable to focus was unable to focus the rack again.
on lane {0}. Please on the load lane. 2. Wait for the lane
close the Sample LED to start
Bay door and load flashing green
the rack again. before loading the
rack.
3. If the problem
persists, contact
Hologic Technical
Support.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.006.00005 Sample rack load The issue could be 1. Unload the rack,
error in lane {0}. due to one of the and check that the
Please unload the following: Sample Rack
rack, then load it Barcode ID has not
again. l The Sample been damaged.
Rack was
loaded too 2. If the barcode is
quickly. intact, load the rack
again in a smooth,
l The Sample forward motion.
Rack was
loaded 3. If the problem
incorrectly. persists, contact
Hologic Technical
l The rack Support.
barcode is
degraded.
407.006.00006 The sample rack in The issue could be 1. Unload the rack,
lane {0} still due to one of the and check that the
contains errors. following: Sample Rack
Remove the rack, Barcode ID has not
correct errors and l The Sample been damaged.
load the rack again. Rack was
loaded too 2. If the barcode is
quickly. intact, load the rack
again in a smooth,
l The Sample forward motion.
Rack was
loaded 3. If the problem
incorrectly. persists, contact
Hologic Technical
l The rack Support.
barcode is
degraded.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.006.00007 The sample rack in The issue could be 1. Remove the rack,
lane {0} was due to one of the ensure that the
rejected because a following: position and
1-character sample barcodes
barcode is present l The sample are intact and load
in the rack. barcode had the the rack again.
incorrect
number of 2. 4–20 barcode
characters characters are
(acceptable required for the
range: 4–20). sample barcodes.
l The scanner 3. If the problem
misread the persists, contact
Tube Position Hologic Technical
Barcode or the Support.
sample barcode.
407.006.00008 Sample ID hand The barcode No action necessary.
scanned: {0} scanner was used
to enter a new
Sample ID.

407.006.00009 Sample ID The Sample ID was No action necessary.

manually entered: changed on the
{0} Sample Details
screen.

407.006.00010 Specimen override Test order(s) were No action necessary.

set for sample: {0} added on the
Sample Details
screen.

407.006.00011 Specimen override Test order(s) were No action necessary.

removed for removed on the
sample: {0} Sample Details
screen.

407.006.00012 External quality N/A No action necessary.

control type
changed to {0} for
sample: {1}

407.006.00013 External quality N/A No action necessary.

control removed for
sample: {0}

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.006.00014 ISBT 128 check N/A No action necessary.
digit overridden for
sample: {0}

407.006.00015 Dilution factor of {0} The sample dilution No action necessary.

set for sample: {1} function is currently
disabled.

407.006.00016 Sample {0} has Samples were No action necessary.

been selected for accepted with LIS
reflex testing reflex test
associations.

407.006.00018 Sample Loading Set assay defaults No action necessary.

defaults set: {0} are applied to the
Assay. Sample Rack Bay
screen.

407.007.00001 Fluids priming N/A No action necessary.

started

407.007.00002 MTUs loaded MTUs were loaded No action necessary.

and the drawer was
locked.

407.007.00003 Sample pipetting Pause was selected No action necessary.

paused on Sample Rack
Bay screen

407.007.00004 Sample pipetting Resume was No action necessary.

resumed selected on Sample
Rack Bay screen.

407.008.00001 Maintenance action N/A No action necessary.

started: {0}

407.009.00001 System state N/A No action necessary.

entered: {0}

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.010.00001 Failed to shut down An abnormal 1. Shut down and
instrument. termination of the restart the Panther
system was System Computer
detected. using the button on
the computer.
2. If the problem
persists, contact
Hologic Technical
Support.
407.011.00001 Event log purge Event log purge No action necessary.
configuration edited configuration was
changed.

407.011.00002 Maintenance log Maintenance log No action necessary.

purge configuration purge configuration
edited was changed.

407.011.00003 Activity log purge Activity log purge No action necessary.

configuration edited configuration was
changed.

407.011.00004 Event logs purged Purge event logs No action necessary.

was selected.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.011.00005 Maintenance logs Purge maintenance No action necessary.
purged logs was selected.

407.011.00006 Activity logs purged Purge activity logs No action necessary.

was selected.

407.012.00001 System User settings were No action necessary.

configuration edited updated.

407.012.00002 LIS configuration LIS settings were No action necessary.

edited updated.

407.012.00003 External Quality External quality No action necessary.

Control controls were
configuration edited updated.

407.012.00004 Reflex Test Reflex testing No action necessary.

configuration edited configuration was
updated.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.012.00005 Default cutoff for Operator made No action necessary.
assay {0}, cutoff {1} changes to cutoff
was set to value ' that is set to always
{2}' and to always use default cutoffs.
use default

407.012.00006 Default cutoff for Changes were No action necessary.

assay {0}, cutoff {1} made to the cutoff.
was set to value '
{2}' and to ask at kit
load

407.012.00008 Manufacturer The manufacturer No action necessary.

Control and quality
Calibrator overrides controls/calibrators
edited were edited.

407.013.00001 Cleared {0} The operator No action necessary.

message(s) selected clear
selected message.

407.013.00002 Cleared all The operator No action necessary.

messages selected clear all
messages.

407.013.00003 Send Logs The operator No action necessary.

executed selected send logs.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.013.00004 Alarm silenced The operator No action necessary.
selected silence
alarm.

407.013.00005 Message filter Messages were No action necessary.

applied: {0} {1} filtered to display:
error, warning, or
informational.

407.014.00001 TestOrders filtered A filter was selected No action necessary.

by Assay: {0} by assay.

407.014.00002 TestOrders filtered A filter was selected No action necessary.

by date: {0} by date.

407.014.00003 TestOrders filtered A filter was selected No action necessary.

by Sample ID: {0} by Sample ID.

407.014.00004 TestOrders filtered A filter by not No action necessary.

by Not Processed processed on
Today today's date has
been selected.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.015.00001 Results filtered on The issue could be No action necessary.
{0}: {1} due to one of the
following:
l A filter is
applied to the
results by the
operator.
l The operator
has navigated
to the Results
screen.

407.015.00002 Results filter The operator has No action necessary.

removed on {0} selected the remove
filter button.

407.015.00003 {0} results selected The operator No action necessary.

for transmission to selected export
LIS results and results
are selected for
export to LIS.

407.016.00001 Report viewed: {0} The report No action necessary.

generated to view
within the software.

407.016.00002 Report printed: {0} The report print has No action necessary.
been completed.

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.016.00003 Report exported: {0} The report export No action necessary.
has been
completed.

407.017.00001 Tips loaded for {0} Tips have been No action necessary.
loaded (tip drawer
locked).

407.018.00001 Lot activated: {0} The master lot has No action necessary.
been registered.

407.018.00002 Lot inactivated: {0} The master lot has No action necessary.
been unregistered.

407.018.00003 Reagent Lot {0} The master lot date No action necessary.
Expiration has been extended.
Extended: {1}

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.018.00004 Assay sequence Assay look up failed 1. Collect logs using
file for {0}, type {1} in a master lot's the Send Logs
has a bad assay type. feature (see Send
Component Logs on page
definition 259).
2. Backup the
database.
3. Contact Hologic
Technical
Support.

407.018.00005 Calibrator Lot {0} The calibrator No action necessary.

Expiration expiration date has
Extended: {1} been extended.

407.018.00006 Control Lot {0} The control No action necessary.

Expiration expiration date has
Extended: {1} been extended.

407.019.00001 Raw data for {0} During data export, No action necessary.
test results were not invalid test order
exported due to measurement time.
invalid
measurement time

407.019.00002 Raw data for {0} During data export, No action necessary.
test results were not no test order curve
exported due to data or fluorometer
unavailable data.
measurement data

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 Appendix C. System Messages

Table 118. System Messages (Continued)

Code Message Possible Cause Solution
407.020.00001 TCR Carousel COP parameter 19 1. Shutdown and
configuration has is different from that restart.
changed. Please of previous software
restart the system. session. Most likely 2. If the problem
caused after the persists, contact
21st position of the Hologic
TCR mixer is Technical
installed. Support.

407.020.00002 TCR Carousel A barcode in the Contact Hologic

scanning has TCR Carousel is Technical Support.
failed. Please either not present,
correct error(s) and misaligned or
close carousel door damaged.
to retry.

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 Appendix D. Support Contact Information

Appendix D. Support Contact Information

Hologic Incorporated
10210 Genetic Center Drive
San Diego, CA 92121 USA

Customer Support: +1 800 442 9892

[email protected]
Technical Support: +1 888 484 4747
[email protected]

For more contact information visit www.hologic.com.

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