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

Panther System®Operator’s Manual
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

Panther System®Operator’s Manual
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

Panther System®Operator’s Manual
AW-17791-001 Rev. 002 (EN) vi
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

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
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

Panther System®Operator’s Manual
AW-17791-001 Rev. 002 (EN) viii
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