ThermoFisher Scientific QuantStudio 12K Flex OpenArray AccuFill... Manual de usuario

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

QuantStudio™12K Flex OpenArray™AccuFill™

System

USER GUIDE

Use and maintenance

for use with:

OpenArray™AccuFill™Instrument

OpenArray™AccuFill™Software v2.0

Catalog Number 4471021

Publication Number MAN0025669

Revision A.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. MAN0025669

Revision Date Description

A.0 30 November 2021 New document for the QuantStudio™12K Flex OpenArray™AccuFill™System (for

OpenArray™AccuFill™Software v2.0).

For documentation for OpenArray™AccuFill™Software v1.2, see “Related

documentation” on page 99.

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

trademark of Roche Molecular Systems, Inc., used under permission and license. Microsoft and Windows are trademarks of Microsoft

Corporation. Symantec is a trademark of Symantec Corporation. McAfee is a trademark of McAfee, LLC.

Contents

■CHAPTER 1 Product information .................................................. 7

Product description ............................................................. 7

About the instrument ............................................................ 8

Overview of the instrument ................................................... 8

About the software ............................................................. 10

Network and password security requirements ................................. 10

Overview of the software ................................................... 10

Installation of or upgrade to OpenArray™AccuFill™Software v2.0 ................ 10

File formats ............................................................... 11

Workﬂow ..................................................................... 13

■CHAPTER 2 Basic operations and one-time procedures ..................... 14

Basic instrument operations ..................................................... 14

Important guidelines for handling an OpenArray™Plate ............................. 15

Set the preferences ............................................................ 15

Set the general settings .................................................... 15

Set the folder defaults ...................................................... 15

Set the plate mapping defaults (full run workﬂow) ............................. 16

■CHAPTER 3 Initialize the system ................................................. 18

Start the system ............................................................... 18

Set up the system .............................................................. 19

Perform a system self-test ...................................................... 19

Overview of the Deck screen .................................................... 21

Reconnect the instrument ....................................................... 22

Recover from a power failure .................................................... 22

■CHAPTER 4 Download or prepare TPF or SPF ﬁles ............................ 23

Download TPF or SPF ﬁles ...................................................... 23

Create TPF or SPF ﬁles from a template .......................................... 24

QuantStudio™12K Flex OpenArray™AccuFill™System User Guide 3

■CHAPTER 5 Map plates ........................................................... 25

Overview of Map Plates features ................................................. 25

Conﬁgure the experiment design to map the plates ................................. 25

Sample plate layouts ....................................................... 27

Map a 384-well plate from 96-well plates .......................................... 30

Set up a 384-well sample plate .................................................. 35

Options to view a plate layout ................................................... 36

Export plate ﬁles ............................................................... 38

■CHAPTER 6 Set up and start the run with the quick run workﬂow ........... 40

Overview of the quick run workﬂow .............................................. 40

Overview of the Quick Run screens .............................................. 41

Before you begin—quick run workﬂow ............................................ 42

Conﬁgure the run—quick run workﬂow ........................................... 43

Conﬁgure the run with sample plate information ............................... 43

Conﬁgure the run without sample plate information ............................ 44

Verify the run setup and start the run—quick run workﬂow .......................... 45

■CHAPTER 7 Set up and start a run with the full run workﬂow ................ 47

Overview of the full run workﬂow ................................................. 47

Overview of the Full Run screens ................................................ 48

Before you begin—full run workﬂow .............................................. 50

Conﬁgure the experiment design for the full run workﬂow ........................... 51

Add or edit sample names—full run workﬂow ...................................... 52

Verify the run setup and start the run—full run workﬂow ............................. 52

■CHAPTER 8 Monitor run progress ............................................... 55

Deck screen during a run ....................................................... 55

Run progress .................................................................. 56

Cancel a run ................................................................... 56

Instrument disconnection during run ............................................. 57

■CHAPTER 9 Prepare the OpenArray™Plate for PCR ........................... 58

Remove the OpenArray™Plate from the instrument ................................. 58

Seal the OpenArray™Plate ...................................................... 61

Contents

4QuantStudio™12K Flex OpenArray™AccuFill™System User Guide

■APPENDIX A Cleaning and maintenance of the OpenArray™

AccuFill™Instrument .............................................................. 63

Cleaning schedule and instructions ............................................... 63

Clean the outside of the instrument .......................................... 63

Clean the inside of the instrument ........................................... 63

Spill accidents ................................................................. 64

■APPENDIX B Required materials not supplied ................................. 65

■APPENDIX C Site requirements .................................................. 67

Dimensions and weights ........................................................ 67

Components (packaged) .................................................... 67

Components (unpackaged) ................................................. 68

Conﬁgured system dimensions and connections .................................. 68

Component clearances required for installation and maintenance .................... 69

Environmental requirements ..................................................... 70

Electrical requirements ......................................................... 71

Electrical protective devices ..................................................... 72

Network requirements .......................................................... 73

Printer requirements ....................................................... 73

Safety requirements ............................................................ 74

Safety practices ........................................................... 74

Required safety equipment ................................................. 74

Third-party software ............................................................ 74

Computer requirements ......................................................... 75

Antivirus software requirements .................................................. 75

■APPENDIX D Manage the service settings ...................................... 76

View the instrument statistics .................................................... 76

Copy or save the instrument statistics ............................................ 77

View the status of the sensors ................................................... 77

Enable or disable the presence sensors ........................................... 78

Perform diagnostics tests ....................................................... 78

Perform a door lock test .................................................... 78

Perform a motion test ...................................................... 79

Perform a tip ejection test ................................................... 80

Perform a tip pickup test .................................................... 80

Perform a plate holder test .................................................. 81

Perform a loading test ...................................................... 81

View loading history log ......................................................... 83

Copy or export the loading history log ............................................ 83

Contents

QuantStudio™12K Flex OpenArray™AccuFill™System User Guide 5

View the instrument log ......................................................... 84

Copy or export the instrument log ................................................ 84

Perform a system self-test (manual start) .......................................... 84

■APPENDIX E Safety ............................................................... 85

Symbols on this instrument ..................................................... 85

Standard safety symbols ................................................... 86

Location of safety labels on the instrument .................................... 86

Control and connection symbols ............................................. 87

Conformity symbols ........................................................ 87

Safety information for instruments not manufactured by Thermo Fisher Scientiﬁc ...... 89

Instrument safety .............................................................. 89

General instrument safety ................................................... 89

Physical injury ............................................................. 91

Electrical safety ........................................................... 93

Cleaning and decontamination .............................................. 94

Instrument component and accessory disposal ................................ 94

Safety and electromagnetic compatibility (EMC) standards .......................... 94

Safety standards .......................................................... 95

EMC standards ............................................................ 95

Environmental design standards ............................................. 96

Chemical safety ................................................................ 97

Biological hazard safety ......................................................... 98

■APPENDIX F Documentation and support ...................................... 99

Related documentation ......................................................... 99

Customer and technical support ................................................. 99

Limited product warranty ...................................................... 100

Index ..................................................................................... 101

Contents

6QuantStudio™12K Flex OpenArray™AccuFill™System User Guide

Product information

■Product description .................................................................... 7

■About the instrument ................................................................... 8

■About the software ................................................................... 10

■Workﬂow ............................................................................ 13

IMPORTANT! Before using this product, read and understand the information in the “Safety” appendix

in this document.

Product description

The QuantStudio™12K Flex OpenArray™AccuFill™System is the automated system for loading DNA

samples and PCR master mix from a 384-well plate to OpenArray™Plates. After the OpenArray™Plates

are loaded, they are ready for real-time PCR on a compatible Applied Biosystems™real-time PCR

instrument.

The QuantStudio™12K Flex OpenArray™AccuFill™System includes the following components:

•OpenArray™AccuFill™Instrument

•OpenArray™AccuFill™Software

•Computer

The following items are key features of the OpenArray™AccuFill™Software v2.0:

•Flexible workﬂow options, including a full run workﬂow and quick run workﬂows

•Download or generation of TPF or SPF ﬁles from within the software

•Creation of 384-well DNA sample plate ﬁles, or mapping 384-well plate ﬁles from 96-well plates,

with easy sample renaming and recovery from pipetting errors

•Export of 96-well and 384-well sample plate ﬁles

•Export of OpenArray™Plate ﬁles in CSV or XLSX format

•Generation of loaded transcript plate ﬁle (TPF) or SNP plate ﬁle (SPF) (integrate the assay

information with the DNA sample information), and export of the ﬁles for import into a compatible

real-time PCR system

•Dispensing of PCR master mix and DNA sample across the surface of the OpenArray™Plate

For more information, see “Overview of the instrument” on page 8 or “Overview of the software” on

page 10.

QuantStudio™12K Flex OpenArray™AccuFill™System User Guide 7

About the instrument

Overview of the instrument

The instrument draws the PCR master mix and sample across the surface of an OpenArray™Plate.

The PCR master mix and sample do not need to be dispensed in speciﬁc volumes because the

through-holes of the OpenArray™Plate are self-metering. The PCR master mix and sample also do not

need to be speciﬁcally dispensed into the through-holes because the through-holes draw the liquid in

by capillary action.

No bubbles are trapped during the dispensing process because there are no closed wells.

For more information about OpenArray™technology, go to thermoﬁsher.com/openarray.

For a description of the software, see “Overview of the software” on page 10.

Figure 1 Parts of the instrument

1Enclosure door

2instrument deck (see Figure 2 on page 9)

3Emergency stop button

Chapter 1 Product information

About the instrument

8QuantStudio™12K Flex OpenArray™AccuFill™System User Guide

Figure 2 Instrument deck

1Tip box holders (2); tip box installed in left holder

2OpenArray™Plate holders (4)

3Sample plate holder with sample plate installed

4Waste bin

Figure 3 Left side panel

1Power switch

2Power cord outlet

3USB port

Chapter 1 Product information

About the instrument 1

QuantStudio™12K Flex OpenArray™AccuFill™System User Guide 9

About the software

Network and password security requirements

Network conﬁguration and security

The network conﬁguration and security settings of your laboratory or facility (such as ﬁrewalls, anti-

virus software, network passwords) are the sole responsibility of your facility administrator, IT, and

security personnel. This product does not provide any network or security conﬁguration ﬁles, utilities, or

instructions.

If external or network drives are connected to the software, it is the responsibility of your IT personnel

to ensure that such drives are conﬁgured and secured correctly to prevent data corruption or loss. It

is the responsibility of your facility administrator, IT, and security personnel to prevent the use of any

unsecured ports (such as USB, Ethernet) and ensure that the system security is maintained.

Password security

Thermo Fisher Scientiﬁc strongly recommends that you maintain unique passwords for all accounts in

use on this product. All passwords should be reset upon ﬁrst sign in to the product. Change passwords

according to your organization's password policy.

It is the sole responsibility of your IT personnel to develop and enforce secure use of passwords.

Overview of the software

The v2.0 software performs the following functions:

•Sets up the OpenArray™AccuFill™Instrument to load OpenArray™Plates with samples from 384-

well plates

•Creates sample plate ﬁles for 384-well plates, which are used to set up the instrument to load the

OpenArray™Plates

•Maps 384-well plates from 96-well plates if samples were prepared in 96-well plates, creating a

384-well sample plate ﬁle

•Allows the download of TPF or SPF ﬁles from thermoﬁsher.com/OA-plateﬁles

•Generates TPF or SPF ﬁles from a template

•Generates loaded TPF or loaded SPF ﬁles for a compatible real-time PCR system

•Generates OpenArray™Plate ﬁles in CSV format to import into a compatible real-time PCR system

•Corrects for loading the 384-well sample plate in a reversed orientation with the plate rotation

feature

Installation of or upgrade to OpenArray™AccuFill™Software v2.0

•Operating system requirement: Windows™10. See also “Computer requirements” on page 75.

•New users: download v2.0 software from thermoﬁsher.com/us/en/home/global/forms/

quantstudio-12k-ﬂex-software-download. Follow the installation wizard.

•Existing v1.2 software users: see the software release notes for v2.0.

Chapter 1 Product information

About the software

10 QuantStudio™12K Flex OpenArray™AccuFill™System User Guide

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