ThermoFisher Scientific QuantStudio 6 Pro Manual de usuario

For Research Use Only. Not for use in diagnostic procedures.

QuantStudio™6 Pro and 7 Pro Real-Time PCR

Systems

USER GUIDE

Publication Number MAN0018045

Revision E.0

Life Technologies Holdings Pte Ltd | Block 33 | Marsiling Industrial Estate Road 3 | #07-06, Singapore 739256

For descriptions of symbols on product labels or product documents, go to thermoﬁsher.com/symbols-deﬁnition.

The information in this guide is subject to change without notice.

DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE

LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR

ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.

Revision history: Pub. No. MAN0018045

Revision Date Description

E.0 27 April 2020 v1.3.0

•Added protein thermal shift experiments to the instrument functions.

•Added a 96-well 0.1-mL block.

•Updated instructions to export data ﬁles when setting up a run and added instructions to import or

delete export settings.

•Updated instructions to save an edited run method.

•Updated instructions to add or edit reagents and then to apply the reagents to the plate.

•Updated instructions to view the ampliﬁcation plot after a run.

•Added instructions to view QC Check status after the run.

•Added information about a locked template ﬁle.

•Added functions for using the instrument with the SAE Administrator Console.

D.0 7 January 2020 v1.2.1

•Added information about position to set up facial authentication and to sign in with facial

authentication.

•Added instructions to test the connection to the Connect cloud-based platform and to view the

•Added instructions to repair the software after a software update.

•Changed port 7000 to 7443 for the instrument-to-computer connection.

•Corrected Ctto Cqin description of instrument veriﬁcation.

C.0 3 December 2019 v1.2.0

•Added a 384-well plate block.

•Updated instructions to set up facial authentication.

•Added a new voice command for calibration.

•Added custom melt curve run calibration.

•Added Security, Auditing, and E‑signature (SAE) v2.0 module.

•Added instructions to generate and reset an access key for external software to connect to the

instrument.

•Added instructions to import an Assay Information File.

•Corrected that a Connect proﬁle is required for the instrument schedule and Smart Help.

•Added new radio compliance standards.

Revision Date Description

B.0 22 August 2019 v1.1.0

•Corrected the text on the buttons for the following items:

–Add facial authentication to an existing instrument proﬁle.

–View the license agreement.

–Reset the instrument (restore factory default).

•Added the following items:

–TET™dye as a system dye.

–Information about sleep mode.

–Information about the automatic sign-out feature.

–The option to conﬁgure the instrument so that sign-in is required (guest access is not

permitted).

–Instructions to set up email notiﬁcation.

–Information about the speaker volume for each user.

–Instructions to back up the instrument and to restore a backup of the instrument.

–Information about multiple instruments and email notiﬁcation in the comparison of a local

instrument proﬁle and a Connect proﬁle.

–Instructions to unlink a Connect proﬁle.

–Instructions to update a PIN for a Connect proﬁle.

–Lighting guidelines for facial authentication.

–Radio compliance standards and RF transceiver speciﬁcations.

•Corrected the following items:

–Indicators for voice commands.

–Voice commands are only available in select countries.

–Instructions to remove VeriFlex™Zones and the Auto Delta setting.

–Excitation and emission wavelengths of the ﬁlters in the calibration instructions.

–Add a four-digit PIN when signing into the instrument for the ﬁrst time using a Connect

proﬁle.

–Add a four-digit PIN when linking a local instrument proﬁle to a Connect proﬁle.

–Select a region for the Connect cloud-based platform.

–A run cannot be started if a block has never been calibrated on the instrument.

–The options after a calibration run is complete.

–The example ﬁles for the desktop software are embedded in the software and do not need to

be downloaded.

•Updated the following items:

–CqExport checkbox is selected as the default.

–Instructions to sign in with facial authentication.

A.0 18 April 2019 New document (v1.0.1).

Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of these

products, you accept the terms and conditions of all applicable Limited Use Label Licenses.

NOTICE TO PURCHASER: DISCLAIMER OF LICENSE: Purchase of this software product alone does not imply any license under any

process, instrument or other apparatus, system, composition, reagent or kit rights under patent claims owned or otherwise controlled

by Thermo Fisher Scientiﬁc, either expressly, or by estoppel.

Trademarks: All trademarks are the property of Thermo Fisher Scientiﬁc and its subsidiaries unless otherwise speciﬁed. TaqMan is a

registered trademark of Roche Molecular Systems, Inc., used under permission and license. Cy is a registered trademark of GE

Healthcare. Amazon, Alexa, and all related logos are trademarks of Amazon.com, Inc. or its aliates. Windows is a trademark of

Microsoft Corporation. Chrome is a trademark of Google LLC. Pentium is a trademark of Intel Corporation or its subsidiaries in the U.S.

and/or other countries. Macintosh is a trademark of Apple Inc., registered in the U.S. and other countries.

Contents

■CHAPTER 1 Product information ................................................ 13

Network and password security requirements ..................................... 13

Network conﬁguration and security .......................................... 13

Password security ......................................................... 13

Instrument hardware description ................................................. 14

Overview of the instrument .................................................. 14

Features of each instrument ................................................. 15

Instrument ﬁlters and supported dyes ........................................ 15

Overview of data collection ................................................. 17

VeriFlex™Zones ........................................................... 17

AutoDelta settings ......................................................... 18

Parts of the instrument ..................................................... 19

Instrument status indicator .................................................. 21

Hands-free features ............................................................ 21

Facial authentication ....................................................... 21

Voice activation ........................................................... 21

Indicators for the hands-free features ........................................ 22

Software description ........................................................... 23

Parts of the home screen ................................................... 23

Connect and Cloud deﬁnitions .............................................. 25

Instrument, desktop software, and Connect platform features ................... 25

Overview of ﬁle locations and ﬁles ........................................... 26

Components of the ﬁles .................................................... 29

Third-party software ....................................................... 30

Network connection options ................................................ 30

Types of runs .................................................................. 30

Standard curve run ........................................................ 30

Relative standard curve run ................................................. 31

Comparative Ct(DDCt) run .................................................. 31

Genotyping run ............................................................ 32

Presence/absence run ...................................................... 32

Melt curve run ............................................................. 32

4QuantStudio™6 Pro and 7 Pro Real-Time PCR Systems User Guide

System template ﬁle names ..................................................... 33

System template ﬁle names for the 96-well 0.2-mL block ....................... 33

System template ﬁle names for the 96-well 0.1-mL block ....................... 34

System template ﬁle names for the 384-well block ............................. 36

Workﬂow ..................................................................... 38

■CHAPTER 2 Get started .......................................................... 39

Precautions for use ............................................................. 39

Installation and instrument veriﬁcation ............................................ 40

Overview of guest access ....................................................... 40

Use the instrument as a guest ............................................... 41

Power on the instrument ........................................................ 42

Enable or disable the microphone ................................................ 44

Use voice commands .......................................................... 44

Sign out ...................................................................... 45

■CHAPTER 3 Create and run plates on the instrument ......................... 46

Options to run a plate .......................................................... 46

Create and run a plate from a system template or a saved plate ﬁle .............. 46

Repeat the last run ......................................................... 48

Overview of customized data export .............................................. 49

(Optional) Scan a barcode using a barcode scanner ................................ 50

Load a plate into the instrument .................................................. 50

Unload a plate from the instrument ............................................... 51

■CHAPTER 4 Edit a plate before starting a run .................................. 52

Overview of a template ﬁle with restricted editing .................................. 52

Options to edit the properties of a plate ﬁle ........................................ 53

Import a sample setup ..................................................... 53

Import an auto export setting ................................................ 53

Delete an auto export setting ................................................ 53

Options to edit the method of a plate ﬁle .......................................... 54

Method elements .......................................................... 55

Edit the method ........................................................... 55

Add or remove steps ....................................................... 56

Add or remove stages ...................................................... 56

Add or remove data collection locations ...................................... 56

Set up or remove VeriFlex™Zones ........................................... 57

Contents

QuantStudio™6 Pro and 7 Pro Real-Time PCR Systems User Guide 5

Set up or remove the Auto Delta feature ...................................... 58

Conﬁgure ramp rates ....................................................... 59

Add or remove a pause ..................................................... 59

Options to edit the well details of a plate ﬁle ....................................... 60

Options to view a plate layout ............................................... 60

View a 384-well plate ....................................................... 61

Assign or edit a well ........................................................ 62

Add or edit the reagent details ............................................... 63

Apply the reagents to a plate ................................................ 63

Delete the reagent details ................................................... 63

Edit a passive reference dye ................................................ 64

Import an Assay Information File (AIF) ........................................ 64

■CHAPTER 5 Options for a run .................................................... 65

Screens available during a run ................................................... 65

Edit a plate ﬁle during a run ..................................................... 66

Pause an instrument run ........................................................ 67

Stop an instrument run ......................................................... 67

View the method during a run ................................................... 68

View real-time data and plots during a run ........................................ 68

Adjust the display of real-time plots during a run ............................... 69

View the time remaining during a run ............................................. 69

Lock the touchscreen during a run ............................................... 69

Unlock the touchscreen during a run ............................................. 70

Instrument Schedule ........................................................... 70

Overview of the instrument schedule ......................................... 70

Schedule a run ............................................................ 70

Cancel a scheduled run .................................................... 71

■CHAPTER 6 View and manage ﬁles ............................................. 72

Manage plate ﬁles .............................................................. 72

Copy plate ﬁles ............................................................ 72

Delete plate ﬁles ........................................................... 73

Manage data ﬁles .............................................................. 73

View QC Check status after a run ............................................ 73

View an ampliﬁcation plot after a run ......................................... 75

Transfer a data ﬁle immediately after a run .................................... 76

Transfer data ﬁles at a later time ............................................. 76

View the list of data ﬁles on the instrument .................................... 77

Delete data ﬁles from the instrument ......................................... 77

Contents

6QuantStudio™6 Pro and 7 Pro Real-Time PCR Systems User Guide

■CHAPTER 7 Calibrate and verify instrument performance ..................... 79

Instrument and block calibration ................................................. 79

Calibration and veriﬁcation schedule ............................................. 80

Calibration descriptions ......................................................... 81

View the calibration status and set reminders ...................................... 81

View the calibration status on the instrument .................................. 81

Set calibration frequency and reminders on the instrument ...................... 82

View calibration status and set reminders on the Connect platform .............. 82

Export a calibration report ....................................................... 83

Perform ROI/uniformity, background, and dye calibrations .......................... 84

Calibration workﬂow ....................................................... 84

Prepare a calibration plate .................................................. 84

Perform calibrations ........................................................ 86

View the calibration images ................................................. 87

Transfer calibration results .................................................. 89

Transfer calibration data ﬁles ................................................ 89

Troubleshoot calibration failure .............................................. 89

Identify contamination ...................................................... 90

Create a background plate (optional) ......................................... 90

Perform veriﬁcation using RNase P plates ......................................... 91

Instrument veriﬁcation description ........................................... 91

RNase P instrument veriﬁcation plate ........................................ 92

Performance speciﬁcations pass criteria ...................................... 93

Prepare an RNase P plate ................................................... 93

Perform RNase P veriﬁcation ................................................ 94

Troubleshoot veriﬁcation failure .............................................. 96

Calibrate custom dyes .......................................................... 98

Overview of custom dyes ................................................... 98

Use a dilution series to determine an optimal custom dye concentration .......... 98

Calibrate the custom dye .................................................. 101

Calibrate for a custom melt curve run ............................................ 104

■CHAPTER 8 Manage proﬁles ................................................... 107

Require sign-in ............................................................... 107

Recommended order to set up proﬁles .......................................... 108

Overview of local instrument proﬁles and Connect proﬁles ......................... 108

Connect instrument proﬁle roles and functions ................................... 109

Test the connection to the Connect platform ..................................... 109

Link the instrument to your Connect account ..................................... 111

Create a new local instrument proﬁle ............................................ 112

Link a local proﬁle to a Connect proﬁle .......................................... 113

Unlink a Connect account ...................................................... 114

Contents

QuantStudio™6 Pro and 7 Pro Real-Time PCR Systems User Guide 7

If you link when you are signed in to the instrument ............................... 115

If you link when you are not signed in to the instrument ............................ 116

Manage individual instrument proﬁles ........................................... 117

Create an administrator instrument proﬁle during initial start-up ................ 117

Set up facial authentication at the initial creation of an instrument proﬁle ........ 117

Add facial authentication to an existing instrument proﬁle ...................... 118

Change the PIN for an instrument proﬁle .................................... 118

Change the PIN for a Connect proﬁle ....................................... 119

Manage all instrument proﬁles as an administrator ................................ 119

View all instrument proﬁles ................................................. 119

Reset the PIN for a proﬁle ................................................. 119

Add a proﬁle ............................................................. 120

Enable or disable administrator privileges .................................... 120

Delete a proﬁle ........................................................... 121

■CHAPTER 9 Use the instrument with the Security, Auditing, and

E‑signature (SAE) v2.0 module ................................................. 122

Overview of the Security, Auditing, and E‑signature (SAE) v2.0 module components ... 123

Overview of the instrument features when the SAE module is enabled ............... 123

Security, Auditing, and E‑signature (SAE) v2.0 module functions .................... 124

Functions that are controlled ............................................... 124

Functions that can be audited ............................................. 125

Functions that can be signed ............................................... 125

Security, Auditing, and E‑signature (SAE) v2.0 module roles ........................ 125

Dialog boxes in the SAE module ................................................ 126

Proﬁles when the SAE module is enabled ........................................ 127

SAE-enabled system components .............................................. 127

Compatibility between SAE-enabled and SAE-disabled components ............ 128

Enable SAE functions ......................................................... 129

Workﬂow: Enable SAE functions ............................................ 129

Conﬁgure SAE Administrator Console application proﬁles ..................... 129

Enable SAE on the instrument and specify the SAE server (administrator only) ... 130

Connect to the SAE server ................................................. 131

Enable SAE functions in QuantStudio™Design and Analysis Software v2 ........ 131

Disable SAE on the instrument (administrator only) ................................ 132

Sign out with SAE enabled ..................................................... 135

Change your SAE account password on the instrument ............................ 136

Sign a plate setup ............................................................. 137

Enter an audit reason .......................................................... 138

View signing records for a plate ﬁle .............................................. 139

Contents

8QuantStudio™6 Pro and 7 Pro Real-Time PCR Systems User Guide

View audit records ............................................................ 140

Use the instrument when the SAE server is oine ................................. 141

E-signature requirements to start a run .......................................... 141

Signing in after automatic screen locking ........................................ 142

SAE error messages and actions ................................................ 142

■CHAPTER 10 Maintain the instrument ......................................... 143

Install a block ................................................................ 143

Change the block ............................................................. 144

Remove the block ............................................................. 145

Decontaminate the sample block ............................................... 146

Materials required ........................................................ 146

Clean the sample block ................................................... 147

Detailed procedures for cleaning the sample block ............................ 148

Replace the instrument fuses ................................................... 149

Materials required ........................................................ 149

Replace the fuses ........................................................ 149

Power on or o, store, and move ................................................ 150

Enable and edit sleep mode ............................................... 150

Power on the instrument ................................................... 151

Power o the instrument ................................................... 151

Prepare the instrument to store, move, or ship ............................... 152

Move the instrument ...................................................... 152

■CHAPTER 11 Conﬁgure the instrument settings .............................. 153

View the instrument details ..................................................... 153

View the license agreement .................................................... 154

View the privacy policy for the Connect cloud-based platform ...................... 154

Conﬁgure the instrument settings ............................................... 155

Enable or disable demonstration mode ...................................... 155

Edit the instrument name (administrator only) ................................ 155

Set the date and the time .................................................. 155

Conﬁgure the heated cover settings ......................................... 156

Adjust the speaker volume ................................................. 156

Conﬁgure the network ..................................................... 156

Select the region for the Connect platform ................................... 157

Select a disk storage management mode .................................... 158

Enable and edit automatic sign-out ......................................... 158

Set an access key for external software to connect to the instrument ............ 159

Reset the access key for external software to connect to the instrument ......... 159

Contents

QuantStudio™6 Pro and 7 Pro Real-Time PCR Systems User Guide 9

Conﬁgure maintenance and service settings ...................................... 159

Request technical support with Smart Help .................................. 159

Request instrument service with Smart Help ................................. 160

Perform a self-veriﬁcation test .............................................. 161

View the last self-veriﬁcation test result ...................................... 161

View the instrument log ................................................... 161

Export the instrument log .................................................. 162

View the instrument statistics .............................................. 162

Enable or disable remote monitoring ........................................ 163

Update the software ...................................................... 163

Repair the software ....................................................... 164

Back up the instrument .................................................... 164

Restore a backup of the instrument ........................................ 165

Overview of an instrument reset (restore factory default) ....................... 165

Reset the instrument (restore factory default) ................................. 166

Conﬁgure the instrument for the hands-free features .............................. 166

Manage the run history ........................................................ 166

Manage the ﬁle name convention of the data ﬁle .................................. 167

View the notiﬁcations .......................................................... 167

Enable and disable home screen notiﬁcations .................................... 168

Set up email notiﬁcations ...................................................... 168

Clear the notiﬁcations ......................................................... 169

■APPENDIX A Instrument speciﬁcations and layout ........................... 170

Instrument dimensions ........................................................ 170

Instrument and computer clearances ........................................ 171

Conﬁgured system dimensions ............................................ 172

Light guidelines .......................................................... 173

Electrical requirements ........................................................ 173

Environmental requirements .................................................... 174

■APPENDIX B Connect the instrument to a network .......................... 175

Connect the computer to the instrument directly or to a LAN ....................... 175

Connect the instrument to a wired network ....................................... 176

Connect the instrument to a wireless network .................................... 177

Instrument and computer connections ........................................... 178

Contents

10 QuantStudio™6 Pro and 7 Pro Real-Time PCR Systems User Guide

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