Hologic Panther System

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Panther System

Operator’s Manual

AW-17791-001 Rev. 002 (EN)

vii

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

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

Main Page

Revision History4
Table of Contents5
Table of Contents6
List of Figures18
Welcome to the Panther® System28
Description and Intended Use28
Using this Manual29
Intended Reader29
What this Manual Covers29
Typographical Conventions29
Safety Symbols30
Terminology30
Special Terminology30
Acronyms/Abbreviations31
Compliance and Safety33
Compliance33
Electromagnetic Compatibility33
Safety33
Panther System Warnings33
System Handling Warnings33
System Environment Warnings35
System Configuration Warnings35
Sample Handling Warnings35
Consumable, Reagent, and Fluid Warnings36
Consumable Warnings36
Reagent Warnings37
Fluid Warnings37
Biological and Chemical Hazards38
Electrical and Mechanical Hazards39
Glove Usage Recommendations40
Limitations41
Table 1. Changing Gloves41
Specifications and Requirements42
Physical Specifications42
Environmental Requirements42
Table 2. Size and Weight Specifications42
Table 3. Clearance Specifications42
Table 4. Environmental Requirements42
Power Requirements43
Table 5. Environmental Output43
Table 6. Power Requirements43
Internal Specifications44
Table 7. Internal Specifications44
Sample Tube Specifications45
Sample Tube Barcode Requirements45
Table 8. Sample Tube Requirements45
Table 9. Barcode Requirements45
Figure 1. Sample Tube Barcode Label Requirements47
Sample Requirements48
Volume Requirements48
Table 10. Allowable Barcode Characters48
Table 11. Panther System Volume Requirements48
Dead Space Volume Requirements49
System Capacities and Throughput50
Table 12. Panther System Dead Space Volume Requirements50
Table 13. System Capacities and Throughput50
Operator Prerequisites51
Overview52
Technology Overview52
Target Capture52
Figure 2. Target Capture53
Transcription-Mediated Amplification (TMA)54
Hybridization Protection Assay (HPA)54
Figure 3. Hybridization Protection Assay55
Dual Kinetic Assay (DKA)56
Real-Time Assays56
Internal Controls for Aptima Assays56
Panther System Overview56
Introduction56
Instrument Overview56
Figure 4. Panther System57
Table 14. Panther System Components57
Canopy58
Figure 5. Canopy58
Table 15. Canopy Location Descriptions58
Panther Upper Bay Components59
Figure 6. Panther Upper Bay59
Table 16. Panther Upper Bay Descriptions59
Reagent Bay60
Figure 7. Reagent Bay60
Panther Tip Drawer Module61
Sample Bay Module61
Target Capture Reagent (TCR) Carousel61
Figure 8. Sample Bay Module61
Panther Pipettor System62
Fluid Pumps62
Panther MID Bay Components62
Figure 9. Panther Pipettor System62
Figure 10. Panther MID Bay63
Table 17. Panther MID Bay Descriptions63
Incubators64
MTU Input Queue65
Distributor65
AMP Load Station65
HPA Load Station65
Magnetic Wash Module65
Sample MIX Station65
Luminometer65
Output Queue66
Panther Lower Bay Components66
Figure 11. Panther Lower Bay66
Table 18. Panther Lower Bay Descriptions66
Computer67
Panther Waste Drawer68
Liquid Waste Container68
Solid Waste Container68
Panther Universal Fluids Drawer68
Naocl Bottle68
Vacuum Pump68
Printer69
Panther System Software Overview69
Introduction69
Accessing the Panther System Software69
Desktop Shield69
Figure 12. Desktop Shield Screen (Example)69
Login Screen70
Navigating the Software70
Figure 13. Login Screen (Example)70
Table 19. Login Screen Interactive Item Descriptions70
Figure 14. Screen Locations (Example)71
Table 20. Universal Screen Interactive Item Descriptions71
Menu Bar72
Interactive Items73
Figure 15. Menu Bar (Example)73
Table 21. Menu Button Descriptions73
Table 22. Interactive Item Descriptions73
Selection Button74
Status Panel74
Figure 16. Row Selection Menu (Example)74
Table 23. Row Selection Menu Buttons74
Status Panel Bars75
Figure 17. Status Panel (Example)75
Table 24. Status Bar Updates75
Additional Status Panel Icons76
Table 25. Additional Status Icon Descriptions76
Additional Status Panel Items77
Table 26. Additional Status Panel Items77
Panther System Software Screens78
Desktop Shield Screen78
Figure 18. Desktop Shield Screen (Example)79
Table 27. Desktop Shield Screen Button Descriptions79
Messages Screen80
Figure 19. Messages Screen (Example)80
Table 28. Message Screen Descriptions80
Comments Screen81
Pending Screen82
Figure 20. Comments Screen (Example)82
Table 29. Comments Screen Descriptions82
Tasks Screen83
Figure 21. Pending Screen (Example)83
Figure 22. Tasks Screen (Example)84
Table 30. Tasks Screen Buttons84
Universal Fluid Bay Screen85
Waste Management Screen86
Figure 23. Universal Fluid Bay Screen (Example)86
Table 31. Universal Fluid Bay Screen Descriptions86
Maintenance Activities Screen87
Figure 24. Waste Management Screen (Example)87
Table 32. Waste Management Screen Descriptions87
Figure 25. Maintenance Activities Screen (Example)88
Table 33. Maintenance Activities Screen Descriptions88
Assay Reagent Bay Screen89
Figure 26. Assay Reagent Bay Screen (Example)89
Assay Reagent Loading Screen90
Table 34. Assay Reagent Bay Screen Descriptions90
Sample Rack Bay Screen91
Figure 27. Assay Reagent Loading Screen (Example)91
Table 35. Assay Reagent Loading Screen Descriptions91
Figure 28. Sample Rack Bay Screen (Example)92
Table 36. Sample Rack Bay Screen Descriptions92
Sample Rack Loading Screen93
Figure 29. Sample Rack Loading Screen (Example)94
Table 37. Sample Rack Loading Screen Descriptions94
Sample Details Screen95
Figure 30. Sample Details Screen (Example)96
Table 38. Sample Details Screen Descriptions96
Run Status Screen97
Figure 31. Run Status Screen (Example)97
Table 39. Run Status Screen Descriptions98
Test Orders Screen99
Figure 32. Test Orders Screen (Example)99
Results Screen100
Figure 33. Results Screen (Example)100
Table 40. Test Orders Screen Descriptions100
Table 41. Results Screen Descriptions101
Report Menu Screen102
Figure 34. Report Menu Screen (Example)102
Table 42. Report Menu Screen Descriptions102
Administration Screen103
Figure 35. Administration Screen (Example)103
Table 43. Administration Screen Button Descriptions103
Data Management Screen104
Figure 36. Data Management Screen (Example)105
Table 44. Data Management Screen Button Descriptions105
System Configuration Screen106
Figure 37. System Configuration Screen (Expanded Example)106
LIS Configuration Screen107
Table 45. System Configuration Screen Descriptions107
Figure 38. LIS Configuration Screen-General Settings (Example)108
Figure 39. LIS Configuration Screen-Serial Settings (Example)109
Figure 40. LIS Configuration Screen-TCP/IP Settings (Example)109
Figure 41. LIS Configuration Screen-File Settings (Example)110
Table 46. LIS Configuration Screen Location Descriptions110
Operator Management Screen111
Change Password111
Figure 42. Operator Management Screen (Example)111
Table 47. Operator Management Screen Location Descriptions111
Quality Control Configuration Screen112
Figure 43. Quality Control Configuration Screen-External Quality Controls Tab (Example)112
Table 48. Quality Control Configuration Screen Button Descriptions (External Quality Controls Tab)112
Reflex Testing Configuration Screen114
Figure 44. Quality Control Configuration Screen-Manufacturer's Controls/Calibrators Tab (Example)114
Table 49. Quality Control Configuration Screen Button Descriptions (Manufacturer's Controls/Calibrators Tab)114
Figure 45. Reflex Testing Configuration Screen (Example)115
Table 50. Reflex Testing Configuration Screen Button Descriptions115
Assay Custom Cutoff Value Configuration Screen116
Help Window116
Figure 46. Help Window (Example)116
Table 51. Help Window Buttons116
Logoff/Shutdown Screen117
Figure 47. Logoff/Shutdown Screen (Example)118
Table 52. Logoff/Shutdown Screen Buttons118
System Operation119
System Startup119
Login/Logoff119
Login119
Logoff120
System Operation120
Load Tips121
Figure 48. Tasks Screen (Example)121
Figure 49. Tip Loading Management Window (Example)122
Table 53. Tip Replacement Options123
Load Mtus124
Load Universal Fluids125
Load Panther Universal Fluids125
Replace Panther Universal Fluids126
Figure 50. Bottle Status Panel (Example)127
Empty Waste128
Empty Waste-Warnings128
Emptying Panther Waste128
Figure 51. Disposing of Liquid Waste Container Contents (Example)130
Perform Maintenance131
Prime Instrument131
Figure 52. Maintenance Activities Screen (Example)131
Prime Criteria132
Table 54. System Prime Resource Consumption132
Prime Procedure133
Force Full Prime133
Load Panther Assay Reagents133
Master Lot Setup133
Add a New Master Lot134
Figure 53. New/Activate Master Log Screen (Example)134
Inactivate a Master Lot135
Reactivate a Master Lot135
Figure 54. Inactivate Master Lot Window (Example)135
Reagent Kit Date Extension136
Loading Panther Assay Reagents into Racks136
Figure 55. Panther Reagent Rack (Example)136
Loading Panther Assay Reagents137
Figure 56. Supplemental Reagent Information Window (Example)138
Unloading Panther Assay Reagents139
Figure 57. Supplemental Reagent Information Window-Redundant Lots (Example)139
Load Samples140
Adding a New Control/Calibrator Lot140
Controls/Calibrators Setup141
Figure 58. Control/Calibrator Lot Entry Screen (Example)141
Figure 59. Sample Rack Bay Screen (Example)141
Control/Calibrator Processing142
Run New Controls/Calibrators142
Loading Samples into Sample Racks143
Sample Defaults144
Adding an Assay to the Sample Defaults144
Figure 60. Panther Sample Rack-With Retainer144
Altering Replicate Count for Sample Defaults145
Figure 61. Sample Defaults Window (Example)145
Deleting an Assay Test from the Sample Defaults146
Configuring Additional Sample Defaults146
Figure 62. Expanded Sample Defaults Window (Example)147
Table 55. Additional Sample Default Options147
Manually Download Test Orders148
Loading Sample Racks148
Load Sample Racks into the Sample Bay148
Assigning a Reagent Lane for Aptima Assays149
Figure 63. Select Reagent Lanes Window (Example)149
Editing Specimen Test Orders150
Adding a Test Order150
Figure 64. Add Test Orders Window (Example)151
Deleting a Test Order152
Scheduling STAT Test Orders153
Running Controls/Calibrators as Specimens154
Dilution Factors154
Figure 65. Process as Specimen Checkbox (Example)154
Apply Dilution Factors155
Delete Dilution Factors155
Unloading Sample Racks156
Initiating Assay Processing157
Pausing Sample Pipetting157
Resume Pipetting Following Pause157
Monitoring the System through Hardware157
System Leds158
Reagent Bay Lane Leds158
Table 56. System LED Status Color Legend158
Table 57. Reagent Bay Lane LED Status Color Legend158
Sample Bay Lane Leds159
Tip Drawer, TCR Door, and MTU Input Queue Leds159
Table 58. Sample Bay Lane LED Status Color Legend159
Table 59. Tip Drawer, TCR Door, and MTU Input Queue LED Status Color Legend159
System Alarm160
Monitoring the System through Software160
Monitoring the Menu Bar160
Table 60. Menu Bar Status Descriptions160
Monitoring the State Indicator161
Table 61. System State Indicators161
Monitoring the Status Panel163
Status Panel164
Status Panel Bars164
Figure 66. Status Panel (Example)164
Table 62. Status Bar Updates164
System Activity Updates165
Additional Status Panel Icons165
Table 63. Status Icon Descriptions166
Monitoring Pending Tasks167
Monitoring Reagent Status167
Panther Assay Reagent Bay Screen167
Figure 67. Temperatures and Sensors Screen (Example)167
Assay Reagent Loading Screen168
Table 64. Reagent Rack Status Color Legend168
Table 65. Assay Reagent Status Color Legend168
Run Status Screen169
Monitoring Test Orders169
Figure 68. Assay Reagent Loading Screen (Example)169
Figure 69. Assay Reagents Panel (Example)169
Viewing Test Orders170
Test Order Status170
Figure 70. Test Orders Screen (Example)170
Table 66. Test Order Screen Fields170
Monitoring Loaded Specimen Status171
Sample Rack Bay Screen171
Table 67. Test Order Status Definitions171
Table 68. Sample Rack Status Color Legend171
Run Status Screen172
Specimen Status173
Figure 71. Run Status Screen (Example)173
Figure 72. Sample Status Locations (Example)174
Table 69. Specimen Status Definitions174
Specimens Panel175
Figure 73. Specimens Loaded Panel-Without LIS (Example)175
Monitoring Control/Calibrator Status176
Assay Reagents Panel176
Figure 74. Specimens Loaded Panel-With LIS (Example)176
Table 70. Control/Calibrator Status Definitions176
Monitoring Results Timing177
Results Management177
Viewing Results177
Figure 75. Assay Reagents Panel (Example)177
Figure 76. Results Panel (Example)177
Results Information178
Figure 77. Results Screen-Expanded (Example)178
Sample Curve Report179
Figure 78. Sample Curve Report (Example)179
Result Details180
User Comment181
Filter Results181
Verifying Results182
Editing Auto-Generated or Manually Entered Sample Ids182
Figure 79. Results Screen with Filters Panel (Example)182
Data Export183
Exporting to a USB Flash Drive183
Removal of a USB Flash Drive183
Figure 80. USB Storage Removal Window (Example)183
Exporting Raw Data184
Exporting LIS Data184
Sending Results to LIS185
Export Viral Data186
Reports Management186
Table 71. Reports187
Selecting Reports189
Figure 81. Report Parameters for Results Report (Example)189
Navigating Reports190
Printing Reports190
Figure 82. Panther System Report Navigation Bar190
Table 72. Report Navigation Buttons190
Exporting Reports191
Reports192
Activity Log Report192
Assay Reagent Report193
Figure 83. Activity Log Report (Example)193
Table 73. Activity Log Report-Report Parameters193
Configuration Report194
Figure 84. Assay Reagent Report (Example)194
Table 74. Assay Reagent Report-Report Parameters194
Diagnostics Log Report195
Figure 85. Configuration Report (Example)195
Table 75. Diagnostics Log Report-Report Parameters196
Exceptions by Worklist Report197
Figure 86. Diagnostics Log Report (Example)197
Table 76. Exceptions by Worklist Report-Report Parameters197
Exceptions Report198
Figure 87. Exceptions by Worklist Report (Example)198
Table 77. Exceptions Report-Report Parameters199
Levey-Jennings Report200
Figure 88. Exceptions Report (Example)200
Table 78. Levey-Jennings Report-Report Parameters201
Lot Search Report202
Figure 89. Levey-Jennings Report (Example)202
Maintenance Checklist203
Figure 90. Lot Search Report (Example)203
Table 79. Lot Search Report-Report Parameters203
Maintenance Log Report204
Figure 91. Maintenance Checklist (Example)204
Table 80. Maintenance Checklist -Report Parameters204
Messages Log Report205
Figure 92. Maintenance Log (Example)205
Table 81. Maintenance Log Report-Report Parameters205
Table 82. Messages Log Report-Report Parameters206
Prevalence Report207
Figure 93. Messages Log Report (Example)207
Table 83. Prevalence Report-Report Parameters207
Results by Worklist Report208
Figure 94. Prevalence Report (Example)208
Table 84. Results by Worklist Report-Report Parameters208
Results Report209
Figure 95. Results by Worklist Report (Example)209
Table 85. Results Report-Report Parameters210
Sample Audit Report211
Figure 96. Results Report (Example)211
Table 86. Sample Audit Report-Report Parameters211
Test Count Report212
Figure 97. Sample Audit Report (Example)212
Table 87. Test Count Report-Report Parameters212
Worklist Lot Report213
Figure 98. Test Count Report (Example)213
Table 88. Worklist Lot Report-Report Parameters213
System Shutdown214
Figure 99. Worklist Lot Report (Example)214
Figure 100. Shutdown Confirmation Window215
Maintenance216
General Maintenance Information216
Maintenance Task Summary216
Table 89. Maintenance Task Summary216
Maintenance Activities Screen217
Maintenance Task Details Screen218
Figure 101. Maintenance Activities Screen (Example)218
Set Maintenance Tasks to Required219
Figure 102. Maintenance Task Details Screen-Clean Sample Shield (Example)219
Schedule an Automated Maintenance Task220
Figure 103. Edit Maintenance Task Screen Mag Wash Cleaning (Example)220
Tracking the Maintenance Schedule221
Figure 104. Scheduled for Automated Start Panel (Example)221
Figure 105. Maintenance Table (Example)221
Maintenance Reports222
Record Maintenance Comments222
Recommended Cleaning Agents222
Figure 106. Maintenance Task Completed Screen (Example)222
Table 90. Recommended Cleaning Agents223
Preparing Sodium Hypochlorite Solution225
Preparing Bleach Enhancer Solution225
Laboratory Check and Cleaning225
Table 91. Environmental Specifications225
Preparing a Clean Workspace226
Clean with Sodium Hypochlorite Solution226
Clean with Prepared Bleach Enhancer Solution (if Applicable)226
Checking for Leaks and Spills226
Mag Wash Clean227
Table 92. Example Mag Wash Maintenance Tasks Cleaning Schedules227
Clean the Sample Shield228
Table 93. Mag Wash Cleaning Inventory228
PC Reboot Maintenance229
Monthly Maintenance230
Step 1. Clean the Monitor and Scanner230
Step 2. Clean the Tip Drawers230
Step 3. Clean the Reagent Bay231
Step 4. Clean the Sample Bay231
Step 5. Clean the Panther Universal Fluid Drawer233
Step 6. Clean the Panther Waste Drawer234
Figure 107. Disposing of Liquid Waste Container Contents (Example)235
Step 7. Clean the External Surfaces236
Replace Mag Wash Cleaning Solution236
Idle Maintenance237
Table 94. Idle Maintenance Procedures237
Clean Sample Racks and Reagent Racks238
Database Maintenance238
Database Backup238
Database Restore239
Delete Database239
System Administration241
Specimen Processing Modes241
Random Access Loading-Bidirectional LIS Host Query241
Manual Download241
Automatic Host Query241
Batch Loading242
Samples with Barcodes242
Samples Without Barcodes242
Database Administration242
Auto Purge Log Configuration243
Purge Logs243
Purge Results244
Configuration245
Figure 108. Purge Results Window (Example)245
User Interface246
Table 95. User Interface Options246
Enable Automatic Log off247
Threshold Management247
Waste Threshold247
Table 96. Threshold Management Options247
Universal Fluid Management248
Table 97. Universal Fluid Management Options248
Priming Management249
Enable Automatic Priming249
Table 98. Priming Management Options249
Assay Reagent Loading250
Default Reconstitution Date Selection250
Figure 109. Assay Reagent Loading Window (Example)250
Table 99. Assay Reagent Loading Options250
Specimen Loading251
Table 100. Specimen Loading Options251
Enable Non-Barcode Sample Loading252
Enable Auto Sample ID Assignment252
Enable Detection and Flagging of Repeat Barcodes/Reject All Repeat Test Orders252
Manual Barcode Entry Mode253
Enable Worklist ID Suffix253
Table 101. Manual Barcode Entry Modes253
ISBT128 Barcodes Enabled254
Results Management254
Enable RLU Value Suppression for Aptima Combo254
Table 102. ISBT128 Barcodes Stripping Options254
Table 103. Results Management Options254
Panther Calibrator And/Or Control Frequency255
Report Management256
Enable Temperature Check Reporting256
Report Export Directory256
Table 104. Report Management Options256
Data Export Management257
Delimiter Character for Export Files257
Table 105. Data Export Management Options257
Raw Data Export Directory258
Security Management258
Figure 110. Delimiter Character for Export Files Window258
Table 106. Security Management Options258
Cybersecurity and Data Protection259
Power Save Management259
Table 107. Power Save Management Options260
Enable Power Save Mode261
Time to End Power Save Mode261
UPS Management261
Printer Management262
Default Printer Name262
Table 108. UPS Management Setting Options262
Table 109. Printer Settings Options262
LIS Configuration263
Table 110. LIS Configuration Options263
Enable LIS Connection264
Disable the LIS Connection265
Enable Automatic Results Holding265
LIS Messages266
Operator Management267
Enable/Disable Operator Accounts267
Adding Operator Accounts267
Table 111. Operator Management Options267
Figure 112. Add Operator Window (Example)268
Editing Operator Accounts269
Table 112. Operator Roles269
Deleting Operator Accounts270
Change Password270
Figure 113. Edit Operator Window (Example)270
Quality Control Configuration271
Figure 114. Change Password Window (Example)271
Adding/Editing Quality Controls272
Adding External Quality Controls272
Table 113. External Quality Control Configuration Options272
Table 114. Manufacturer's Controls/Calibrators Configuration Options272
Figure 115. Add Quality Control Window (Example)273
Editing Quality Controls274
Copying External Quality Controls274
Deleting Quality Controls275
Loading Unlabeled Quality Controls275
Figure 116. Copy Quality Control Window (Example)275
Selecting Assays During EQC Loading276
Adding Manufacturer Control/Calibrator Overrides276
Figure 117. Add Manufacturer Control/Calibrator Override Window (Example)277
Reflex Testing Configuration278
Table 115. Reflex Testing Configuration Options278
Configuring Automatic Reflex Test Order Assignment279
Configuring Reflex Test Order Assignment During Rack Load279
Designating Reflex Tests During Sample Rack Loading280
Assay Custom Cutoff Value Configuration280
Troubleshooting281
Hologic Technical Support281
Troubleshooting over the Phone281
Troubleshooting with PRO360° Software281
Initiating a Remote Diagnostics Session281
Figure 118. Remote Diagnostics Management Window282
Figure 119. PRO360° Software Window (Example)282
Terminating a Remote Diagnostics Session283
Panther System Operator's Manual283
Instrument Information283
Figure 120. PRO360° Software Connection in Progress (Example)283
Instrument Info Panel284
Module Information284
Assay Versions284
Figure 121. Instrument Info Window-Module Information View (Example)284
Silence Alarm285
Force MTU Unload285
Figure 122. Instrument Info Window-Assay Versions View (Example)285
Send Logs286
Figure 123. Send Logs Window (Example)286
Send Logs Directly to Service Support287
Disposing of Contaminated Waste287
Figure 124. Disposing of Liquid Waste Container Contents (Example)288
Dropped Tip Inside Sample Tube289
Resolving Barcode Issues290
Using the Handheld Scanner for Unreadable Barcodes290
Figure 125. Sample Rack Loading Screen During Barcode Error (Example)290
Using the Virtual Keyboard for Unreadable Barcodes291
Unresponsive System Shutdown291
Replaceable Parts292
Vacuum Trap Filter Replacement292
Universal Fluid Caps Replacement295
Waste Bottle O-Rings Replacement296
Appendix A. Panther System Operation Checklist298
Appendix B. Processing Flags299
Assay Processing Flags299
Table 116. Assay Processing Flags301
Results Processing Flags310
Table 117. Results Processing Flags310
Appendix C. System Messages317
Table 118. System Messages397
Appendix D. Support Contact Information425

Hologic Panther System - Page 9

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