Hologic Panther System Manual de usuario

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: +1 800 442 9892

customersupport@hologic.com

Technical Support: +1 888 484 4747

molecularsupport@hologic.com

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.

Panther System®Operator’s Manual

AW-17791-001 Rev. 002 (EN) ii

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

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

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

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

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