Hologic Panther System User manual

Before using this document, please consult Agile for the latest revision. Form ENG-0034-T01, Rev. 006
TITLE
DOCUMENT NUMBER
REV
PANTHER OPERATOR'S MANUAL, V 6.2,
GLOBAL, IVD, ENGLISH AW-17791-001 002
SIZE A SHEET 1OF 1
REV AUTHORED BY
DATE
CHRIS WALSH
04/09/21
REV DRAFTED BY
DATE
CHRIS WALSH
04/09/21
PROPRIETARY: This document contains
proprietary data of Hologic, Inc. No
disclosure, reproduction or use of any part
thereof may be made except by written
permission from Hologic.
REV. RELEASE DATE: 05/04/2021

Panther System®Operator’s Manual
AW-17791-001 Rev. 002 (EN) i
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:
Customer Support: [phone]
[e-mail]
Technical Support: [phone]
[e-mail]
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) ii
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
903448 A Use marking and Material
Nubmer 2012-03
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
AW-12347 001 Formatting throughout, Real Time
TMA, Quantitative Assay 2014-10
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
AW-17791 002 Updated European Authorized
Representative 2020-02

Panther System®Operator’s Manual
AW-17791-001 Rev. 002 (EN) iii
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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AW-17791-001 Rev. 002 (EN) iv
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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AW-17791-001 Rev. 002 (EN) v
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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Table of Contents
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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Table of Contents
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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Table of Contents
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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AW-17791-001 Rev. 002 (EN) xvi
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