ThermoFisher Scientific QuantStudio 1 Plus Instrucciones de instalación y funcionamiento

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

QuantStudio™1 Plus Real-Time PCR System

INSTALLATION, USE, AND MAINTENANCE

Publication Number MAN0024786

Revision A.0

Thermo Fisher Scientiﬁc (Shanghai) Instruments Co., Ltd. | T71-6, No. 211, Qin Qiao road, China (Shanghai) Free Trade Zone, China

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. MAN0024786

Revision Date Description

A.0 8 April 2021 New document for the QuantStudio™1 Plus Real-Time PCR System.

Important Licensing Information: This product may be covered by one or more Limited Use Label Licenses. By use of this product,

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

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. Microsoft and Windows are trademarks of Microsoft Corporation. Pentium is a trademark of Intel Corporation. Google and

Chrome are trademarks of Google, Inc.

Contents

About this guide ........................................................... 8

■CHAPTER 1 Product information .................................................. 9

Instrument hardware description .................................................. 9

Instrument overview ......................................................... 9

Parts of the instrument ..................................................... 11

Parts of the home screen ................................................... 12

Software description ........................................................... 14

Features of the instrument, desktop, and Thermo Fisher™Connect software ...... 14

Folders, templates, experiments, and projects ................................. 15

Third-party software ....................................................... 17

Supported options for instrument and computer connections ........................ 17

Experiment types .............................................................. 19

■CHAPTER 2 General procedures to operate the instrument ................... 21

Precautions for use ............................................................. 21

Power on the instrument ........................................................ 22

Power o the instrument ........................................................ 22

Sign out ...................................................................... 23

Load and unload a plate in the QuantStudio™1 Plus Real-Time PCR Instrument ....... 23

Transfer, view, or manage ﬁles and results ......................................... 24

Transfer EDS ﬁles from the instrument home screen ............................ 24

View run history and delete or transfer ﬁles from the instrument ................. 24

Manage templates (EDT ﬁles) ................................................ 25

■CHAPTER 3 Conﬁgure the instrument and manage instrument proﬁles ..... 26

Initial start‑up .................................................................. 26

Installation and instrument veriﬁcation ............................................ 27

Use the instrument without signing in ............................................. 27

Create an administrator instrument proﬁle during initial start-up ...................... 27

Create a new instrument proﬁle .................................................. 28

Overview of Settings ........................................................... 29

QuantStudio™1 Plus Real-Time PCR System Installation, Use, and Maintenance Guide 3

Manage instrument settings ..................................................... 31

Manage the instrument name (Administrator only) .............................. 32

Enable Sleep Mode ........................................................ 32

Set the idling temperature for the heated cover ................................ 32

Conﬁgure the network drive ................................................. 32

OEM connection only (Administrator only) ..................................... 33

Select a region for Thermo Fisher™Connect (Administrator only) ................. 33

Set the date and time (Administrator only) ..................................... 33

Conﬁgure the network ...................................................... 33

Restore factory defaults .................................................... 35

Select a language .......................................................... 35

Learn about the instrument ...................................................... 35

View instrument speciﬁcations .............................................. 35

View and export the License Agreement ...................................... 36

Manage home screen notiﬁcations ............................................... 36

Manage maintenance, service, and calibrations .................................... 36

Update instrument software (Administrator only) ............................... 36

Enable remote instrument monitoring (Administrator only) ....................... 37

View instrument statistics ................................................... 37

View instrument logs ....................................................... 37

Manage Users ................................................................. 38

Require instrument proﬁle sign-in (Administrator only) .......................... 38

Manage the Sign Out Timer (Administrator only) ............................... 38

Manage instrument proﬁles ................................................. 38

Link an instrument proﬁle to Thermo Fisher™Connect .............................. 39

Link an existing instrument proﬁle to Thermo Fisher™Connect .................. 40

Create a new instrument proﬁle and link to Thermo Fisher™Connect ............. 40

■CHAPTER 4 Create and run experiments on the instrument .................. 41

Workﬂow ..................................................................... 41

Run an experiment ............................................................. 42

Create and run an experiment from a template ................................ 42

Run an experiment from a saved ﬁle ......................................... 42

Repeat the last instrument run ............................................... 43

Edit an experiment before starting a run .......................................... 44

Enter or edit template properties ............................................. 44

Edit the run method ........................................................ 45

Deﬁne, assign, and view well details ......................................... 48

View, pause, or stop a run ....................................................... 49

View real-time data and plots on the instrument touchscreen .................... 49

Adjust the display of real-time plots on the instrument touchscreen .............. 49

Pause or stop an instrument run ............................................. 50

Lock the touchscreen during a run ........................................... 50

Transfer EDS ﬁles from the instrument home screen ................................ 50

Contents

4QuantStudio™1 Plus Real-Time PCR System Installation, Use, and Maintenance Guide

■CHAPTER 5 Calibrate and verify instrument performance ..................... 52

Calibration and veriﬁcation schedule ............................................. 52

Calibration descriptions ......................................................... 53

View the calibration status and set reminders ...................................... 54

View calibration status and set reminders in the instrument ..................... 54

View calibration status and set reminders in Thermo Fisher™Connect ............ 54

Perform ROI/uniformity, background, and dye calibrations .......................... 55

Workﬂow: Calibration ...................................................... 55

Prepare a calibration plate .................................................. 56

Perform calibrations ........................................................ 57

View calibration images and transfer results to USB ............................ 58

Troubleshoot calibration failure .............................................. 59

Identify contamination ...................................................... 59

Create a background plate (optional) ......................................... 60

Perform instrument veriﬁcation using RNase P plates ............................... 60

Instrument veriﬁcation description ........................................... 61

RNase P instrument veriﬁcation plate ........................................ 61

Performance speciﬁcations pass criteria ...................................... 62

Prepare an RNase P plate ................................................... 62

Perform RNase P veriﬁcation ................................................ 63

Troubleshoot veriﬁcation failure .............................................. 64

Calibrate custom dyes .......................................................... 65

Custom dyes overview ..................................................... 65

Use a dilution series to determine an optimal custom dye concentration .......... 65

Calibrate the custom dye ................................................... 67

Calibrate for a custom melt curve experiment ...................................... 70

■CHAPTER 6 Maintain the instrument ............................................ 73

Backup or restore the instrument ................................................ 73

Decontaminate the sample block ................................................ 74

Materials required .......................................................... 74

Clean the sample block ..................................................... 74

Detailed procedures for cleaning the sample block ............................. 76

Replace the instrument fuses .................................................... 77

Materials required .......................................................... 77

Replace the fuses .......................................................... 77

Prepare the instrument to store, move, or ship ..................................... 78

Move the instrument ....................................................... 78

Return the instrument for service ............................................ 79

Contents

QuantStudio™1 Plus Real-Time PCR System Installation, Use, and Maintenance Guide 5

■APPENDIX A Install and connect the instrument to a network ................ 80

Workﬂow: Install and connect to a network ........................................ 80

Before you begin ............................................................... 81

Instrument and computer connections ............................................ 81

Unpack and install the instrument ................................................ 82

Power on and follow the startup wizard ........................................... 83

Connect the instrument and the computer directly or to a LAN ....................... 84

Networking .................................................................... 85

Supported options for instrument and computer connections ................... 85

Control and monitor networked instruments ................................... 86

Ethernet port overview ..................................................... 87

Firewall ports that must be open ............................................. 87

Networking guidelines and best practices ..................................... 87

■APPENDIX B Troubleshooting .................................................... 88

■APPENDIX C Instrument speciﬁcation and layout .............................. 90

Conﬁgured system dimensions .................................................. 91

Instrument clearances ...................................................... 92

Electrical requirements ......................................................... 92

Environmental requirements ..................................................... 93

Network requirements .......................................................... 93

■APPENDIX D Parts and materials ................................................ 95

Kits, consumables, accessories, and reagents ..................................... 95

Consumables (96‑well, 0.2‑mL format) ............................................ 95

Accessories .................................................................. 96

General-use materials and consumables .......................................... 96

■APPENDIX E Safety ............................................................... 98

Symbols on this instrument ..................................................... 98

Conformity symbols ........................................................ 99

Safety alerts on this instrument ................................................. 100

Location of safety labels on the instrument .................................. 100

Safety information for instruments not manufactured by Thermo Fisher Scientiﬁc ..... 101

Instrument safety ............................................................. 101

General ................................................................. 101

Physical injury ............................................................ 101

Electrical safety .......................................................... 101

Cleaning and decontamination ............................................. 102

Contents

6QuantStudio™1 Plus Real-Time PCR System Installation, Use, and Maintenance Guide

Safety and electromagnetic compatibility (EMC) standards ......................... 102

Safety compliance ........................................................ 102

EMC .................................................................... 103

Environmental design ..................................................... 103

Chemical safety .............................................................. 104

Biological hazard safety ....................................................... 105

■APPENDIX F Documentation and support ..................................... 106

Related documentation ........................................................ 106

Customer and technical support ................................................ 106

Limited product warranty ...................................................... 106

Index ..................................................................................... 107

Contents

QuantStudio™1 Plus Real-Time PCR System Installation, Use, and Maintenance Guide 7

About this guide

This guide provides information about installing, using, and maintaining the QuantStudio™1 Plus Real-

Time PCR System. For information and instructions on performing experiments on this system, see the

QuantStudio™Design and Analysis SC Software v1.0 User Guide (Pub. No. MAN0024784).

8QuantStudio™1 Plus Real-Time PCR System Installation, Use, and Maintenance Guide

Product information

■Instrument hardware description ........................................................ 9

■Software description .................................................................. 14

■Supported options for instrument and computer connections .............................. 17

■Experiment types ..................................................................... 19

Instrument hardware description

Instrument overview

The QuantStudio™1 Plus Real-Time PCR System uses ﬂuorescence-based polymerase chain reaction

(PCR) reagents to perform the following types of experiments:

•Quantitative detection of target nucleic acid sequences (targets)

•Qualitative detection of targets

•Qualitative analysis of the PCR product

For more information, see “Experiment types” on page 19.

The instrument is conﬁgured with a 96-well 0.2-mL ﬁxed block and a 4-color coupled ﬁlter set.

The instrument can be run directly from the touchscreen to create and start experiments. To design

experiments or to analyze data, the instrument can be integrated with the QuantStudio™Design and

Analysis SC Software v1.0.

The instrument can be used with the Thermo Fisher™Connect Platform.

QuantStudio™1 Plus Real-Time PCR System Installation, Use, and Maintenance Guide 9

An optional barcode scanner and optional wireless adapter can be ordered separately.

Instrument ﬁlters and supported dyes

System dyes

The instrument uses a coupled four-color ﬁlter set that supports the dyes shown in the following table

and ﬁgure. For more information about available spectral dye calibration kits, contact Support.

Table 1 Filters and supported dyes

Peak ﬁlter Color

Filter wavelength[1] Factory-calibrated

dyes Example custom dyes

Excitation Emission

x1-m1 Blue 470 ± 15 nm 520 ± 15 nm FAM™dye,

SYBR™Green SYT09

x2-m2 Green 520 ± 10 nm 558 ± 12 nm VIC™dye JOE™dye, HEX™dye,

TET™dye[2]

x4-m4 Orange 580 ± 10 nm 623 ± 14 nm ROX™dye, JUN™dye Texas Red™dye

x5-m5 Red 640 ± 10 nm 682 ± 14 nm MUSTANG PURPLE™

dye, Cy®5LIZ™dye

[1] The central wavelengths are the optimized wavelengths.

[2] The HEX™and TET™dyes from Thermo Fisher Scientific fall within the emission wavelength range of the system, therefore they can

be added and adapted for use on the instrument.

Filters

Wavelength

(nm)

1 2 34

x1-m1 x2-m2 x4-m4 x5-m5

Emission

Spectra

1x1-m1—FAM™dye, SYBR GREEN™dye

2x2-m2—VIC™dye

3x4-m4—JUN™dye, ROX™dye, Texas Red™dye

4x5-m5—Cy®5, MUSTANG PURPLE™dye

Custom dyes

The instrument can run assays that are designed with custom dyes. Custom dyes include the following

dyes:

•Dyes that are not supplied by Thermo Fisher Scientiﬁc.

•Dyes or formulations of dyes that are not system dyes for the instrument.

Chapter 1 Product information

Instrument hardware description

10 QuantStudio™1 Plus Real-Time PCR System Installation, Use, and Maintenance Guide

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