Thermo Scientific QuantStudio 1 Installation, Use And Maintenance Manual

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QuantStudio™ 1 Real-Time PCR System
INSTALLATION, USE, AND MAINTENANCE
Firmware v1.0.x
Publication Number MAN0017853
Revision A.0
For Research Use Only. Not for use in diagnostic procedures.
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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. MAN0017853 (English)
Revision Date Description
A.0 10 October 2018 New document.
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.
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.
©2018 Thermo Fisher Scientific Inc. All rights reserved.
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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
Instrument, desktop, and cloud software features ............................. 14
Folders, templates, experiments, and projects ................................ 15
Third-party software ....................................................... 16
Supported options for instrument and computer connections ........................ 16
Experiment types .............................................................. 18
CHAPTER 2 General procedures to operate the instrument ........ 20
Precautions for use ............................................................ 20
Power on the instrument ........................................................ 21
Power off the instrument ....................................................... 21
Sign in ........................................................................ 21
Sign out ....................................................................... 21
Load and unload a plate in the QuantStudio™ 1 Real-Time PCR Instrument ............ 22
Transfer, view, or manage files and results ........................................ 23
Transfer EDS files from the instrument home screen ........................... 23
View run history and delete or transfer files from the instrument ................ 23
Manage templates (EDT files) ............................................... 23
CHAPTER 3 Configure the instrument and manage
instrument profiles ....................................................... 25
Initial startup ................................................................. 25
Installation and instrument verification ........................................... 26
Use the instrument without signing in ............................................ 26
Create an administrator instrument profile during initial start-up .................... 27
Create a new instrument profile ................................................. 27
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Contents
Overview of Settings ............................................................ 28
Manage instrument settings ..................................................... 30
Manage the instrument name (Administrator only) ............................. 31
Enable Sleep Mode ........................................................ 31
Set the idling temperature for the heated cover ................................ 31
Configure the network drive ................................................. 31
OEM connection only (Administrator only) ..................................... 31
Select a Cloud region (Administrator only) .................................... 32
Set the date and time (Administrator only) .................................... 32
Configure the network ...................................................... 32
Restore factory defaults .................................................... 34
Select a language .......................................................... 34
Learn about the instrument ..................................................... 34
View instrument specifications .............................................. 34
View and export the License Agreement ...................................... 35
Manage home screen notifications ............................................... 35
Manage maintenance, service, and calibrations .................................... 35
Update instrument software (Administrator only) .............................. 35
Enable remote instrument monitoring (Administrator only) ..................... 36
View instrument statistics .................................................. 36
View instrument logs ....................................................... 36
Manage Users ................................................................. 36
Require instrument profile sign-in (Administrator only) ......................... 37
Manage the Sign Out Timer (Administrator only) ............................... 37
Manage instrument profiles ................................................. 37
Link an instrument profile with the Thermo Fisher Cloud ........................... 38
Link an existing instrument profile with the Thermo Fisher Cloud ................ 38
Create a new instrument profile and link with the Thermo Fisher Cloud .......... 38
CHAPTER 4 Create and run experiments on the instrument ....... 39
Workflow ..................................................................... 39
Run an experiment ............................................................. 40
Create and run an experiment from a template ................................ 40
Run an experiment from a saved file ......................................... 40
Repeat the last instrument run .............................................. 41
Edit an experiment before starting a run .......................................... 41
Enter or edit template properties ............................................ 41
Edit the run method ........................................................ 43
Define, assign, and view well details ......................................... 45
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View, pause, or stop a run ....................................................... 46
View real-time data and plots on the instrument touchscreen ................... 46
Adjust the display of real-time plots on the instrument touchscreen .............. 47
Pause or stop an instrument run ............................................. 47
Lock the touchscreen during a run ........................................... 47
Transfer EDS files from the instrument home screen ............................... 48
CHAPTER 5 Calibrate and verify instrument performance ......... 49
Calibration and verification schedule ............................................. 49
Calibration descriptions ........................................................ 50
View the calibration status and set reminders ..................................... 51
View calibration status and set reminders in the instrument .................... 51
View calibration status and set reminders in the Cloud ......................... 51
Perform ROI/uniformity, background, and dye calibrations .......................... 52
Workflow: Calibration ...................................................... 52
Prepare a calibration plate .................................................. 52
Perform calibrations ....................................................... 53
View calibration images and transfer results to USB ........................... 54
Troubleshoot calibration failure ............................................. 55
Identify contamination ...................................................... 56
Create a background plate
Perform instrument verification using RNase P plates .............................. 57
Instrument verification description .......................................... 57
RNase P instrument verification plate ........................................ 58
Performance specifications pass criteria ..................................... 58
Prepare an RNase P plate ................................................... 58
Perform RNase P verification ............................................... 59
Troubleshoot verification failure ............................................. 61
Calibrate custom dyes .......................................................... 62
Custom dyes overview ...................................................... 62
Use a dilution series to determine an optimal custom dye concentration .......... 62
Calibrate the custom dye ................................................... 65
Calibrate for a custom melt curve experiment ..................................... 68
(optional)
......................................... 56
Contents
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Contents
CHAPTER 6 Maintain the instrument ................................. 70
Backup or restore the instrument ................................................ 70
Decontaminate the sample block ................................................. 71
Materials required ......................................................... 71
Clean the sample block ..................................................... 71
Detailed procedures for cleaning the sample block ............................. 73
Replace the instrument fuses .................................................... 73
Materials required ......................................................... 73
Replace the fuses .......................................................... 74
Prepare the instrument to store, move, or ship .................................... 74
Move the instrument ....................................................... 75
Return the instrument for service ............................................ 75
APPENDIX A Install and connect the instrument to a network ..... 77
Workflow: Install and connect to a network ........................................ 77
Before you begin ............................................................... 78
Instrument and computer connections ............................................ 78
Unpack and install the instrument ............................................... 79
Power on and follow the startup wizard ........................................... 80
Connect the instrument and the computer directly or to a LAN ....................... 80
Networking ................................................................... 81
Supported options for instrument and computer connections .................... 81
Control and monitor networked instruments .................................. 82
Ethernet port overview ..................................................... 83
Firewall ports that must be open ............................................ 83
Networking guidelines and best practices ..................................... 83
APPENDIX B Troubleshooting ......................................... 84
APPENDIX C Instrument specification and layout ................... 86
Configured system dimensions .................................................. 87
Instrument clearances ..................................................... 88
Electrical requirements ......................................................... 88
Environmental requirements .................................................... 89
Network requirements .......................................................... 90
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APPENDIX D Parts and materials ..................................... 91
Kits, consumables, accessories, and reagents ..................................... 91
Consumables (96well, 0.2mL format) ............................................ 91
Accessories ................................................................... 92
General-use materials and consumables ......................................... 92
APPENDIX E Safety ..................................................... 93
Symbols on this instrument ..................................................... 94
Conformity symbols ........................................................ 95
Safety alerts on this instrument .................................................. 96
Location of safety labels on the instrument ................................... 97
Safety information for instruments not manufactured by Thermo Fisher Scientific ..... 97
Instrument safety .............................................................. 97
General .................................................................. 97
Physical injury ............................................................ 98
Electrical safety ........................................................... 98
Cleaning and decontamination ............................................... 98
Safety and electromagnetic compatibility (EMC) standards .......................... 98
Safety compliance ......................................................... 99
EMC ...................................................................... 99
Environmental design ..................................................... 100
Chemical safety ............................................................... 100
Biological hazard safety ........................................................ 101
Contents
Documentation and support ........................................... 102
Related documentation ........................................................ 102
Obtain information from the Help system ........................................ 102
Customer and technical support ................................................ 102
Limited product warranty ...................................................... 103
Index ..................................................................... 104
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About this guide

This guide provides information about installing, using, and maintaining the QuantStudio™ 1 Real-Time PCR System. For information and instructions on performing experiments on this system, refer to QuantStudio™ Design and Analysis Desktop Software User Guide (Pub. No. MAN0010408).
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1
Instrument hardware description ........................................ 9
Software description .................................................. 14
Supported options for instrument and computer connections .............. 16
Experiment types ..................................................... 18

Instrument hardware description

Product information

Instrument overview

The QuantStudio™ 1 Real-Time PCR System uses uorescence-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 18.
The instrument is congured with a 96-well 0.2-mL xed block and a 3-color coupled lter 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 Software.
An optional barcode scanner and optional wireless adapter can be ordered separately.
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Filters
Wavelength (nm)
1
2
3
x1-m1 x2-m2 x4-m4
Emission Spectra
Chapter 1
1
Instrument hardware description
Product information
Instrument filters and supported dyes
System dyes
The instrument use a coupled three-color lter set that supports the dyes shown in the following table and gure. For more information about available spectral dye calibration kits, contact Support.
Filter wavelength
Peak
filter
Color
(nm)
[1]
Factory-calibrated
dyes
Example
custom dyes
Excitation Emission
x1-m1 Blue 470 ± 15 520 ± 15
x2-m2 Green 520 ± 10 558 ± 12 VIC
x4-m4 Orange 580 ± 10 623 ± 14 ROX™, JUN
[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.
FAM™,
SYBR™ Green
SYT09
JOE™,
HEX™, TET™
Texas Red
[2]
10
1
x1-m1 — FAM™, SYBR™ Green
2
x2-m2 — VIC
3
x4-m4 — JUN™, ROX™, Texas Red
Custom dyes
The instrument can run assays designed with custom dyes. Custom dyes include the following:
• Dyes that are not supplied by Thermo Fisher Scientic.
• Dyes or formulations of dyes that are not system dyes for the instrument.
To use a custom dye on the instrument, review the following requirements.
• Calibrate the instrument for the custom dye (see “Calibrate custom dyes“ on page 62).
• Ensure that the custom dye excites and emits within the wavelength range of the lters (see the lter-wavelength table in “System dyes“).
• Select a custom dye that does not overlap with other dyes used in the run (see the lter-wavelength table in “System dyes“).
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1
2
3

Parts of the instrument

Chapter 1 Product information
Instrument hardware description
1
Touchscreen – Controls the instrument.
2
USB port – For connection to an external network drive or external data storage device.
3
Instrument drawer – Contains sample plate.
The instrument includes three additional USB ports on the back of the instrument.
Note: The instrument recognizes only one external storage device at a time for data transfer.
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4
3
9
1
5
6
8
7
2
Chapter 1 Product information
1
Instrument hardware description

Parts of the home screen

1
Avatar and Instrument name
2
Help icon
3
Drawer status
4
Status dial
5
Current user name; instrument block type
Table 2 Parts of the home screen
Element of the
home screen
Avatar and
Function For more information, see...
Set by the administrator to uniquely identify instrument. “Manage the instrument name
Instrument name
Help icon Touch to launch the touchscreen Help system to access
step-by-step instructions.
Drawer status
— The drawer is locked. The drawer locks during experiment runs, calibration runs, and self verification test runs. The drawer automatically unlocks when a run is complete.
— The drawer is unlocked.
Drawer is open — The drawer is open. No message displays when the drawer is closed.
6
Settings button
7
Buttons for accessing Experiment Template files (EDT)
8
Connectivity icons
9
Sign In (or My Profile) button
(Administrator only)“ on page 31.
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Chapter 1 Product information
Instrument hardware description
1
Element of the
home screen
Status dial
Current user name and block type
Settings button Touch Settings to configure, calibrate, or learn about
Buttons for accessing experiment and template files
• When the instrument is in use — Displays the sample block temperature, the elapsed run time, and the run status.
You can swipe the dial to the left or touch to access real-time views of the run.
• When the instrument is not in use — Displays Set up run. You can start a run by touching the status dial.
Displays the user name of the current signed-in user and the instrument block type.
Note: If no user is signed-in, the instrument defaults to the Guest profile.
the instrument.
Load Experiment — Touch to open a user-created EDT file from a Cloud account, USB, instrument folder, or network drive.
Open Template — Touch to open a system EDT template
file.
Function For more information, see...
Chapter 3, “Configure the instrument and manage instrument profiles“.
“Run an experiment from a saved file“ on page 40 .
“Create and run an experiment from a template“ on page 40“Run an experiment from a saved file“ on page 40 .
Connectivity icons
Sign In button
(My Profile button when a user is signed in)
Run Last — Touch to open the last EDT file run on the instrument.
• If you are signed-in, the file opened will be the last file you ran when signed-in.
• If you are not signed-in, the file opened will be the last file the guest profile ran.
— The instrument is connected to a wired network.
— The instrument is wirelessly connected.
— A USB drive is plugged into the instrument.
— The instrument is linked to a Cloud account.
• Touch Sign In to sign into an instrument profile and link to a Cloud account.
• Touch My Profile to change instrument profile settings, link to a Cloud account, or lock the instrument during a run.
“Repeat the last instrument run“ on page 41.
“Sign in“ on page 21.
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Chapter 1 Product information
1

Software description

Software description

Instrument, desktop, and cloud software features

The instrument and the software (desktop and cloud) include the features described in the following table.
Feature Instrument Desktop Cloud
Use as guest (no sign in) 3 3 — Create templates (unlocked or locked) 3 3 Edit unlocked templates 3 3 3
Edit locked templates (password assigned by template creator required)
Load system or user-created templates (EDT file) to instrument
Change experiment settings in template (EDT file) loaded on the instrument
Settings that can be changed in a locked template (no password required):
• Properties: All settings
• Method: No changes allowed
• Plate: Sample names
Settings that can be changed in an unlocked template:
• Properties: All settings
• Method: All settings
• Plate: Sample names
3 3
3 3
3
14
Load plate in instrument 3 — Start run 3 3 — View real-time data during a run 3 3 3
View instrument status (running, calibration needed, and so on)
Analyze results 3 3 Set calibration reminders 3 3
Review exported calibration or RNase P verification results
QuantStudio™ 1 Real-Time PCR System Installation, Use, and Maintenance Guide
3 3
3 3
(
only RNase P
)
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Chapter 1 Product information
Software description
1

Folders, templates, experiments, and projects

Term
Folders in Load Experiment
Experiment Template File (EDT)
Experiment Run File (EDS)
Definition Supported in
Location in which you can store templates (EDT files) on the instrument:
My Instrument – Displayed if you are signed in
Public – Location in which all experiments run by guest users are stored
USB – USB for manual transfer to and from a computer
Post Read – If you run an endpoint experiment, the pre-read experiment is automatically saved in this folder for post-read analysis
Default settings for an instrument run, can be modified before instrument run.
Two types:
• Factory-provided, accessed from Open Template (instrument) or Create Experiment (desktop or cloud)
• User-created, accessed from Load Experiment
Settings and data for a completed instrument run. Instrument
Instrument
Instrument
Desktop
Cloud
Desktop
Template and experiment components
Properties
Method
Project Function in the Cloud Data Manager that is used for
secondary analysis applications. Does not apply to the cloud software, which is a primary analysis application.
Instrument Desktop Cloud
• Experiment file name
• Reagent information (Reagent barcode, Lot#)
• Plate barcode
• Data destination (location for auto-transfer of data)
• Comments (Tags are not used at this time)
Thermal cycling conditions Thermal cycling conditions
• Experiment file name
• Plate barcode
• User name
• Instrument type
• Block type
• Experiment type
• Chemistry (reagent information)
• Run mode
• Comments
• (
Cloud software only
) Notifications
Cloud
Cloud
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Chapter 1 Product information
1

Supported options for instrument and computer connections

Template and experiment components
Instrument Desktop Cloud
Plate Sample names
You cannot edit targets/SNP assays or tasks on the instrument.
Run Start and monitor a run in progress
View: Time remaining and Temperature, Method, Plots
Pause, Resume, Stop a run
Results Not applicable Review plots
Export Not applicable Export results

Third-party software

Before installing third-party software on the computer running QuantStudio™ Design and Analysis Desktop Software, conrm that the third-party software will not do the following:
• Restrict Ethernet communication.
• Interfere with instrument or computer operation.
Define and assign samples, targets or SNP assays, and tasks in the Quick Setup and Advanced Setup panes of the Plate tab.
Start and monitor a run in progress
View: Time remaining and Temperature, Method, Plots
Monitor a run in progress (link to Thermo Fisher Cloud Instrument Details)
View: Time remaining and Temperature, Method, Plots
Supported options for instrument and computer connections
We support the following direct, networked (LAN– local area network), or Cloud
congurations. Congurations other than those listed are not recommended. Select a conguration that meets the needs of your laboratory's instrument, software, and workow requirements.
IMPORTANT! Do not connect both an Ethernet cable and the Wi-Fi module
(Cat. No. A26774) to the instrument. Conguring the instrument for both wired and wireless connection can interfere with instrument operation.
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LAN
LAN
LAN
Supported options for instrument and computer connections
Chapter 1 Product information
Note: For detailed information about networking your instrument, see the
QuantStudio™ 1 Real-Time PCR System IT Checklist (Pub. No. MAN0018164).
Direct configuration option
• A computer provided by Thermo Fisher Scientific with the QuantStudio™ Design and Analysis Desktop Software
• Computertoinstrument connection: – Direct, wired connection between the computer and the instrument
using an Ethernet cable
1
IMPORTANT! A direct instrumenttocomputer connection
with the LAN or the Cloud configurations.
Networked configuration option
• A computer provided by Thermo Fisher Scientific with the QuantStudio™ Design and Analysis Desktop Software
• The computer and instrument must be on the same subnet mask.
• ComputertoLAN connection – Wired connection to the network using an Ethernet cable –
– Wireless connection to the network
• InstrumenttoLAN connection – Wired connection to the network using an Ethernet cable –
– Wireless connection to the network using the instrument WiFi module
Thermo Fisher Cloud configuration option
• Internet access and a computer with the Chrome™ web browser to access the Cloud
• ComputertoCloud connection – Wired connection to the internet using an Ethernet cable –
– Wireless connection to the internet
(select an option)
(select an option)
(select an option)
:
cannot
:
:
be combined
or
or
or
• InstrumenttoCloud connection – Wired connection to the network using an Ethernet cable –
– Wireless connection to the network using the instrument WiFi module
QuantStudio™ 1 Real-Time PCR System Installation, Use, and Maintenance Guide
(select an option)
:
or
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Chapter 1 Product information
1

Experiment types

Experiment types
Purpose
Standard curve experiment
Determines absolute target quantity in samples.
Relative standard curve experiment
Determines relative target quantity in samples.
Description
1. The software measures amplification of the target in a standard dilution series and in test samples.
2. The software generates a standard curve using data from the standard dilution series.
3. The software uses the standard curve to interpolate the absolute quantity of target in the test samples.
1. The software measures amplification of the target of interest and of an endogenous control target in a standard dilution series, in a reference (calibrator) sample, and in test samples.
The endogenous control is a target that is expressed equally in all samples; examples of endogenous controls are βactin, GAPDH, and 18S ribosomal RNA. The software can algorithmically incorporate multiple endogenous control targets in relative quantification calculations.
The reference sample is used as the basis for relative quantification results (or 1× sample). For example, in a study of drug effects on gene expression, an untreated control is an appropriate reference sample.
2. The software generates standard curves for the target of interest and the endogenous control using data from the corresponding standard dilution series.
3. The software uses the standard curves to interpolate the quantities of the target of interest and the endogenous control in each sample. The target quantity in each sample is then normalized to the sample's endogenous control quantity.
4. To determine the relative quantity of the target in test samples, the software divides the normalized target quantity in the sample by the normalized target quantity in the reference sample.
Comparative C
Determines relative target quantity in samples.
(DDCt) experiment
t
18
1. The software measures amplification of the target of interest and of an endogenous control target in a reference (calibrator) sample and in test samples.
The endogenous control is a target that is expressed equally in all samples; examples of endogenous controls are βactin, GAPDH, and 18S ribosomal RNA. The software can algorithmically incorporate multiple endogenous control targets in relative quantification calculations.
The reference sample is used as the basis for relative quantification results (or 1× sample). For example, in a study of drug effects on gene expression, an untreated control is an appropriate reference sample.
2. The measurements for the target of interest are normalized to the endogenous control.
3. To determine the relative quantity of the target in test samples, the software compares the normalized ΔCq (ΔCt or ΔCrt) for the sample to the normalized ΔCq (ΔCt or ΔCrt) for the reference sample.
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Chapter 1 Product information
Experiment types
1
Purpose
Genotyping experiment
Detects single nucleotide polymorphism (SNP) variants of a target nucleic acid sequence.
Presence/absence experiment
Determines the presence or absence of a target nucleic acid sequence in a sample.
Description
Genotyping experiments use preformulated TaqMan® SNP Genotyping Assays that include the following components:
• Two sequence-specific primers for amplification of sequences containing the SNP of interest
• Two allele-specific TaqMan® probes for Allele 1 and Allele 2
1. The software normalizes the fluorescence of the reporter dyes to the fluorescence of
2. The software plots the normalized reporter dye signal of each sample well on an Allelic
3. The software algorithmically clusters the sample data, and assigns a genotype call to
The software calls the target present or absent based on an algorithmically determined call threshold. (The call threshold is different from the Ct threshold; the Ct threshold is not used to make calls.)
the passive reference dye in each well.
Discrimination Plot, which contrasts the reporter dye intensities of the allele-specific probes.
the samples of each cluster according to its position on the plot.
Melt curve experiment
Determines the melting temperature (Tm) of the
amplification
products of a PCR that used intercalating dyes.
In the software, melt curve analysis is included in the default run method for any experiment type that uses intercalating dyes.
1. The software plots a melt curve based on the fluorescence of the dye with respect to change in temperature.
2. Using the melt curve, the software calculates the melting temperature (Tm).
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2
Precautions for use ................................................... 20
Power on the instrument .............................................. 21
Power o the instrument .............................................. 21
Sign in .............................................................. 21
Sign out ............................................................. 21
Load and unload a plate in the QuantStudio™ 1 Real-Time PCR Instrument .. 22
Transfer, view, or manage les and results ............................... 23

Precautions for use

General procedures
to operate the instrument
CAUTION! PHYSICAL INJURY HAZARD. Do not remove the instrument
cover. There are no components inside the instrument that you can safely service yourself. If you suspect a problem, contact technical support.
CAUTION! FIRE HAZARD. For continued protection against the risk of re,
replace fuses only with listed and certied fuses of the same type and rating as those currently in the instrument.
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation, the
sample block temperature can reach 100°C. Allow it to cool to room temperature before handling.
CAUTION! Before using a cleaning or decontamination method other than
those recommended by Thermo Fisher Scientic, conrm with Thermo Fisher Scientic that the proposed method will not damage the instrument.
CAUTION! Use at caps for tubes. Rounded caps can damage the heated cover.
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Power on the instrument

Touch anywhere on the touchscreen to determine if the instrument is in sleep
1.
mode. If the home screen is displayed, the instrument is already powered on.
If the home screen does not display,
2.
power on the instrument by pressing the switch on the rear panel.
If left unaended (for about two hours), the instrument automatically enters sleep mode (enabled by default) to conserve power.
Note: To customize the sleep mode seing, touch
Seings4Sleep Mode.
Seings4Instrument

Power off the instrument

Chapter 2
General procedures to operate the instrument
Power on the instrument
2

Sign in

The instrument operates in low-power mode when not in use. However, the instrument can be powered o completely so that the components use no power.
Note: To power o the instrument for >1 week, see “Prepare the instrument to store, move, or ship“ on page 74.
Power o the instrument using the power switch on the back of the instrument.
1.
Power o the computer.
2.
Create an instrument prole before signing into the instrument. See “Create a new instrument prole“ on page 27.
Note: An instrument prole is a user account specically for the instrument. It is not related to any other user account for the system or software.
In the home screen, touch Sign In.
1.
Touch Sign In, then select your username.
2.
Enter your PIN, then touch Enter.
3.

Sign out

In the home screen, touch
1.
Touch Sign Out.
2.
QuantStudio™ 1 Real-Time PCR System Installation, Use, and Maintenance Guide
My Prole.
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Chapter 2 General procedures to operate the instrument
2

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

Load and unload a plate in the QuantStudio™ 1 Real-Time PCR Instrument
CAUTION! Use at caps for 0.2-mL tubes. Rounded caps can damage the
heated cover.
Load the plate.
1.
Open the instrument drawer.
a.
Load the plate onto the plate adapter so that the following criteria are met.
b.
• Well A1 of the plate is in the top-left corner of the plate adapter.
• The barcode faces the front of the instrument.
Note: Do not remove the black plate adapter before loading a plate or tube strips. If used, tube strips can t loosely in the adapter, but the heated cover will apply the appropriate pressure to seat the tube strips securely in the adapter.
Close the instrument drawer.
c.
When the run ends, unload the plate.
2.
Open the instrument drawer.
a.
Remove the plate.
b.
Close the instrument drawer.
c.
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation,
the plate temperature can reach 100°C. Allow it to cool to room temperature before handling.
22
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Chapter 2 General procedures to operate the instrument
Transfer, view, or manage files and results
In the home screen, when a run ends, touch Transfer File.
Transfer EDS
files
from the instrument home screen
1.
Select the data destination for the EDS le.
2.
Navigate to and select a folder.
3.
Touch OK.
4.
Touch Transfer.
5.
Transfer, view, or manage files and results
2
View run history and delete or transfer files from the instrument
Manage templates (EDT files)
Note: Touch
In the home screen, touch Seings4Run History.
• Touch an individual run record to view its details, then complete one of the following actions:
– Touch Delete to delete the run record.
– Touch Transfer to export the run data.
• Touch Manage to select multiple run records for simultaneous viewing, deletion, or transfer.
Note:
Guests (users not signed-in) can only view guest run records.
·
Users signed into their instrument proles can also view their own run records.
·
Administrators can view all run records.
·
Note: If the connection between the instrument and the desktop software is interrupted during the run, the instrument still completes the run. However, the run data (EDS le) must be transferred from the instrument to the desktop software using a USB drive or a network drive.
This feature applies to templates (EDT les) on a manage run results les (EDS les), see “Transfer EDS les from the instrument home screen“ on page 23.
Seings4Run History to transfer EDS les at any time.
USB or in My Instrument. To
In the home screen, touch Load Experiment.
1.
Touch USB or My Instrument.
2.
Touch Manage Files.
3.
(Optional) Navigate through the My Instrument, Public, USB, and Post Read
4.
folders to access an EDT le. Folder availability depends on your sign-in status.
Touch one or more les to select for managing.
5.
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Chapter 2 General procedures to operate the instrument
2
Transfer, view, or manage files and results
Delete or copy the les.
6.
• Touch Delete Files, then conrm deletion.
• Touch Copy Files, select a le destination, then touch Paste Files.
Touch Done.
7.
24
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3
Configure the instrument and
manage instrument profiles
Initial start-up ....................................................... 25
Installation and instrument verication ................................. 26
Use the instrument without signing in .................................. 26
Create an administrator instrument prole during initial start-up ........... 27
Create a new instrument prole ........................................ 27
Overview of Seings .................................................. 28
Manage instrument seings ........................................... 30
Learn about the instrument ............................................ 34
Manage home screen notications ...................................... 35
Manage maintenance, service, and calibrations ........................... 35

Initial startup

Manage Users ....................................................... 36
Link an instrument prole with the Thermo Fisher Cloud ................. 38
Perform these tasks during initial instrument start-up or after you restore factory defaults (see “Restore factory defaults“ on page 34).
(Optional) Select one of the following options.
1.
Congure the instrument for either wired connection or wireless network connection (see “Congure the network“ on page 32).
• Touch Neither/Decide Later.
(Optional) Enter an instrument name (see “Manage the instrument name
2.
(Administrator only)“ on page 31).
Set the date and time (see “Set the date and time (Administrator only)“ on
3.
page 32).
Select one of the following options.
4.
• Select a Cloud region (see “Select a Cloud region (Administrator only)“ on page 32).
• Touch Next to continue.
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Chapter 3 Configure the instrument and manage instrument profiles
3
Installation and instrument verification
Create an administrator prole (see “Create an administrator instrument prole
5.
during initial start-up“ on page 27).
Select one of the following options.
6.
• Link the instrument prole to the Thermo Fisher Cloud (see “Link an existing instrument prole with the Thermo Fisher Cloud“ on page 38).
• Touch Skip.
Installation and instrument verification
Before the rst use of the instrument, complete the following tasks:
• Install the instrument (see “Unpack and install the instrument“ on page 79).
• Verify instrument performance (see “Perform instrument verication using RNase P plates“ on page 57).
Note:
Instruments are factory calibrated, so no calibration is necessary at installation.
·
However, we recommend that you verify instrument performance before using the instrument. Regular calibration and verication should be performed according to the
·
calibration and verication schedule (see “Calibration and verication schedule“ on page 49).

Use the instrument without signing in

If the instrument is congured by an Administrator to allow guest access ( Seings4Manage Users4Sign In Required set to o), you can use the instrument without signing in.
The following limits are in place if you do not sign in to the instrument:
• All actions are recorded to Guest user prole.
• You have access only to the Public folder for selecting and storing experiments.
• You cannot transfer data to the Cloud (only to USB or network drive).
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Chapter 3 Configure the instrument and manage instrument profiles
Create an administrator instrument profile during initial start-up
Create an administrator instrument profile during initial start-up
During initial start-up, the user is automatically prompted to create an administrator instrument prole. See “Initial start-up“ on page 25.
• The rst instrument prole that is created during installation is given administrator privileges.
• Administrators can grant administrative privileges to other users. See “Manage all instrument proles (Administrator only)“ on page 37.
Touch Name, enter a username, then touch Done.
1.
Touch PIN, enter a four-digit numerical password, then touch Enter.
2.
Note: Touch the Show PIN checkbox to switch PIN display on or o.
Touch Conrm PIN, then repeat step 2.
3.
Touch Create prole.
4.
3
Create a new instrument profile
In the home screen, touch
1.
Touch Name, enter a username, then touch Done.
2.
Touch PIN Code, enter a four-digit numerical password, then touch Enter.
3.
Note: Touch the Show PIN checkbox to switch PIN display on or o.
Touch Conrm PIN, then repeat step 2.
4.
Touch Create prole.
5.
Sign in to the prole you just created. See Sign in.
6.
Note: To enable access to the Thermo Fisher Cloud, see “Link an instrument prole
with the Thermo Fisher Cloud“ on page 38.
Sign In, then touch Get Started.
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Chapter 3 Configure the instrument and manage instrument profiles
3

Overview of Settings

Overview of Settings
Touch Seings in the home screen to congure seings as needed.
Access to many seings are restricted to administrator instrument proles.
Touch for step-by-step instructions on conguring seings.
Options
Instrument Settings
Instrument Name
(Administrator only)
Sleep Mode Enable the instrument to enter a standby mode after a set length of inactivity.
Heated Cover Temperature Set the idling temperature for the heated cover (before it enters sleep mode).
Network Drive
Insert Plate Reminder Enable a reminder to insert a plate before starting a run from the instrument.
OEM Connection Only
(Administrator only)
Cloud Region
(Administrator only)
[1]
Description
Enter a unique instrument name, and
Specify a default network drive for transferring files from the instrument.
Required for API access to the instrument. When enabled, the software (desktop and cloud) cannot connect to the instrument.
API access to the instrument is exclusive to authorized OEM partners.
Specify the regional server location to access the Thermo Fisher Connect Dashboard.
Note: Once you set a Cloud region, restore factory defaults to change the region.
(optional)
set an instrument avatar.
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Chapter 3 Configure the instrument and manage instrument profiles
Options Description
Date/Time Set time zone and date and time formats.
Network Connection Set wired or wireless network connection for the instrument.
Restore Factory Defaults Restore the instrument to the factory settings.
IMPORTANT! Back up the instrument before restoring factory defaults (see “Backup
or restore the instrument“ on page 70).
Note: Restoring an instrument to the factory defaults results in the following setting changes:
Instrument profiles and files stored on the instrument are deleted, including all EDS
·
files and any custom dye calibrations. The most recent valid ROI/Uniformity, Background, and system dye calibrations are
·
not deleted.
Language Specify the language to display on the touchscreen.
About Instrument
Overview of Settings
3
About Instrument Displays the instrument Model Name, Block Serial Number, and Firmware Version.
License Agreement Displays the End User Software License Agreement and the Limited Product Warranty.
You can export the License Agreement to a USB drive.
Notifications
Enable home screen notifications of instrument errors and software updates. This
function is not related to the Notifications function in the cloud software.
The number of new, unviewed notifications displays over Settings in the home screen.
Maintenance and Service
Software Update
(Administrator only)
Monitoring
(Administrator only)
Instrument Statistics Displays instrument usage information including Block Cycle Count and LED Life.
Calibrations
Update the instrument software.
Enable the Remote Monitoring Service to automatically notify Thermo Fisher Scientific support teams in real-time of potential instrument problems.
The service monitors and sends general monitor or send
• Perform calibrations – ROI and Uniformity
DyeCustom (including Background calibration)
• View calibration history and set calibration reminders in History and Reminders
customer
data.
instrument
data, but the service does not
RNase P Verification Perform instrument performance verification using an RNase P plate.
Self Verification Test Check the instrument hardware functions.
Log View and export Instrument Run Log.
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Chapter 3
3

Manage instrument settings

Options Description
Backup / Restore
Ship Prep Mode Place the instrument in a safe state for moving or long term storage.
Run History
Displays the instrument runs and whether the EDS file for the run was transferred.
Manage Users
Configure the instrument and manage instrument profiles
• Backup the instrument
• Restore an instrument backup
Touch a run to view the details or to transfer or delete (Administrator only) the EDS file.
[1]
Sign In Required
(Administrator only)
Sign Out Timer
(Administrator only)
Manage Profiles
(Administrator only)
[1]
Also available to standard and guest instrument profiles.
Enable only signed-in users to access the instrument for any task, including accessing Settings. Enabling this feature disables the guest profile access to the instrument.
Note: Instrument runs must be started from the desktop software, and actions during an instrument run are automatically logged to the guest instrument profile (even if a user was signed into the instrument).
Set the time length of inactivity before a user is automatically signed out.
Access the profile information for the instrument.
Manage instrument settings
In the home screen, touch Seings4Instrument Seings to access the following functions.
“Manage the instrument name (Administrator only)“ on page 31
“Enable Sleep Mode“ on page 31
“Set the idling temperature for the heated cover“ on page 31
30
“Congure the network drive“ on page 31
“OEM connection only (Administrator only)“ on page 31
“Select a Cloud region (Administrator only)“ on page 32
“Set the date and time (Administrator only)“ on page 32
“Congure the network“ on page 32
“Restore factory defaults“ on page 34
“Select a language“ on page 34
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Manage the instrument name (Administrator only)

Chapter 3 Configure the instrument and manage instrument profiles
In the home screen, touch Seings4Instrument Seings4Instrument
1.
Name.
Touch the Instrument Name eld, enter an instrument name, then touch Done.
2.
(Optional) Touch Add Avatar to associate an avatar with the instrument.
3.
Insert a USB drive with image les to use this option.
Touch OK.
4.
Manage instrument settings
3

Enable Sleep Mode

Set the idling temperature for the heated cover

Configure the network drive
In the home screen, touch
1.
Slide the control On to enable sleep mode.
2.
Touch Edit Time, then enter the time length of inactivity before the instrument
3.
enters sleep mode.
Touch Enter, then touch OK.
4.
In the home screen, touch
1.
Idle Temperature.
Slide the control On to set the idling temperature for the heated cover.
2.
Touch the Edit Temperature eld, then enter the desired idling temperature.
3.
Touch Enter, then touch OK.
4.
In the home screen, touch Seings4Instrument Seings4Network Drive.
1.
Note: Contact a representative from your information technologies department
for the IP address.
Enter a Drive Location.
2.
Seings4Instrument Seings4Sleep Mode.
Seings4Instrument Seings4Heated Cover
Enter a Domain Name, User Name, and Password, if required.
3.
Touch Connect.
4.
OEM connection only (Administrator
This seing is required for API access to the instrument. When enabled, the desktop software cannot connect to the instrument. Do not access unless instructed to do so by a service representative.
only)
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Chapter 3 Configure the instrument and manage instrument profiles
3
Manage instrument settings

Select a Cloud region (Administrator only)

Set the date and time (Administrator only)

During the initial startup, you will be automatically prompted to select a Cloud region. Return to the selection through Seings, if necessary.
In the home screen, touch Seings4Instrument Seings4Cloud Region.
1.
Touch a region.
2.
The server used to store your data is located in this region.
Touch OK.
3.
In the home screen, touch
1.
Select a time zone from the dropdown list.
2.
Select a date format.
3.
Touch Date Format, then select the preferred date format.
a.
Touch Next, touch the date eld, then enter the date.
b.
Touch Enter, then touch Done.
c.
Select a time format.
4.
Touch Time Format.
a.
Seings4Instrument Seings4Date/Time.
Configure the network
Slide the control to select a 12-hour or 24-hour clock.
b.
Touch Next, touch the time eld, then enter the time.
c.
Touch Enter, then touch Done.
d.
Touch Done.
5.
IMPORTANT! Congure the instrument for either wired connection or wireless
connection but not both.
“Set up a wired connection“ on page 33
“Set up a wireless connection“ on page 33
32
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Chapter 3 Configure the instrument and manage instrument profiles
Manage instrument settings
Set up a wired connection
In the home screen, touch Seings4Instrument Seings4Network
1.
Connection4 Wired.
In the Network Conguration screen, touch a radio buon to connect to a
2.
network either by DHCP or by a Static IP address.
Option Action
Automatic Touch DHCP.
3
Manual
Note:
dynamically. For static addresses, you need to know the IP address for the instrument, the Subnet Mask, and the Default Gateway.
Touch OK.
3.
1. Touch Static IP.
2. Enter the IP address for the instrument, the Subnet Mask, the Default Gateway, and Secondary DNS Server.
Addresses are in the form of X.X.X.X, where each X is a number from 0 to 255.
Ask your system administrator if the IP address is assigned statically or
(optional)
the Primary DNS Server and the
Set up a wireless connection
In the home screen, touch
1.
Connection4 Wireless to display a list of the available networks.
Select a network or touch Join other network, enter the network password, then
2.
touch Enter. If you select Join other network, enter the network name and security type.
Touch Join to continue.
3.
Seings4Instrument Seings4Network
In the Network Connection Complete screen, touch Next.
4.
Touch OK.
5.
In the Network Conguration screen, edit the Network details or touch Done.
6.
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Chapter 3 Configure the instrument and manage instrument profiles
3

Learn about the instrument

Restore factory defaults

Select a language

IMPORTANT! Back up the instrument before restoring factory defaults (see “Backup
or restore the instrument“ on page 70).
In the home screen, touch Seings4Instrument Seings4Restore Factory
1.
Defaults.
Touch Restore Factory Defaults.
2.
Power O, then power On the instrument to apply the change.
3.
• Instrument proles and les stored on the instrument are deleted, including all EDS les and any custom dye calibrations.
• The most recent valid ROI/Uniformity, Background, and system dye calibrations are not deleted.
After restoring factory defaults, perform initial start-up tasks. See “Initial start-up“ on page 25.
In the home screen, touch Seings4Instrument Seings4Language.
1.
Touch the desired language selection.
2.
Touch OK.
3.
Learn about the instrument
In the home screen, touch Seings4About Instrument to access the following information.
“View instrument specications“ on page 34
“View and export the License Agreement“ on page 35
View instrument
specifications
In the home screen, touch Seings4About Instrument4About Instrument to access the following information.
• Model Name
• Wired IP Address
• Wireless IP Address
• Instrument Serial Number
• Block Serial Number
• UUID
• Firmware Version
• Thermal Block Controller
• Instrument Server
• User Interface
34
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Chapter 3 Configure the instrument and manage instrument profiles
In the home screen, touch Seings4About Instrument4License Agreement

View and export the License Agreement

1.
to view the license agreement.
Touch Export to export the license agreement.
2.
Touch Done.
3.
Manage home screen notifications
Manage home screen notifications
3
In the home screen, touch
1.
Screen Notications.
Slide the control On or O to enable or disable individual notications, or touch
2.
Clear All to remove all notications.
Touch Close.
3.
Seings4Notications to view and manage Home

Manage maintenance, service, and calibrations

In the home screen, touch following functions.
“Update instrument software (Administrator only)“ on page 35
“Enable remote instrument monitoring (Administrator only)“ on page 36
“View instrument statistics“ on page 36
Chapter 5, “Calibrate and verify instrument performance“
“View instrument logs“ on page 36
“Backup or restore the instrument“ on page 70
“Prepare the instrument to store, move, or ship“ on page 74
Seings4Maintenance and Service to access the
In the home screen, touch Seings4Maintenance and Service4Software
Update instrument software
1.
Update.
Touch USB or Cloud to select the location of the update les.
2.
(Administrator only)
QuantStudio™ 1 Real-Time PCR System Installation, Use, and Maintenance Guide
When prompted, conrm your request to update the software.
3.
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Chapter 3 Configure the instrument and manage instrument profiles
3

Manage Users

Enable remote instrument monitoring (Administrator only)

In the home screen, touch Seings4Maintenance and Service4Monitoring.
1.
Congure the instrument monitoring seings.
2.
Option Description
Remote Monitoring Service
Slide the control On to enable the Remote Monitoring Service. Enabling the Remote Monitoring Service allows the instrument
to automatically notify Thermo Fisher Scientific support teams in real time of potential instrument issues. The service monitors and sends general monitor or send
instrument
customer
data, but the service does not
data.

View instrument statistics

View instrument logs

Thermo Fisher Cloud Monitor
Touch OK.
3.
In the home screen, touch Seings4Maintenance and Service4Instrument Statistics to view the following statistics.
• Disk Space Remaining (MB)
• Block Cycle Count
• Block Degrees Climbed
• LED Life
• RNase P Status
In the home screen, touch Seings4Maintenance and Service4Log.
1.
Touch Instrument Run Log to view the log records.
2.
(Optional) Touch a category on the left to lter the log table by event type.
3.
(Optional) Touch an individual log record to view details.
4.
Slide the control On to enable users to access realtime monitoring of amplification plots from the Thermo Fisher Cloud dashboard.
Manage Users
36
(Optional) Export log records:
5.
• Touch Export4
• Touch Export4 Cloud, then touch Export.
• Touch Export4 Network.
In the home screen, touch Seings4Manage Users to access the following functions.
“Require instrument prole sign-in (Administrator only)“ on page 37.
“Manage the Sign Out Timer (Administrator only)“ on page 37.
“Manage all instrument proles (Administrator only)“ on page 37.
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USB.
Page 37
Require instrument profile sign-in (Administrator only)
Chapter 3 Configure the instrument and manage instrument profiles
In the home screen, touch Seings4Manage Users4Sign In Required.
1.
Slide the control On.
2.
Only signed-in users are allowed to access the instrument for any task, including access to Seings.
Touch Done.
3.
Manage Users
3
Manage the
Sign Out Timer
(Administrator only)
Manage instrument
profiles
To
Create a profile
Configure a profile
View or manage all
profiles
In the home screen, touch Seings4Manage Users4Sign Out Timer.
1.
Touch the Edit Time eld, then enter the desired duration of inactivity before
2.
automatic user sign out.
Touch Enter, then touch Done.
3.
Note: An instrument prole is a user account specically for the instrument. It is not
related to any other user account for the system or software.
See
• “Create an administrator instrument profile during initial start-up“ on page 27
• “Create a new instrument profile“ on page 27
• “Link an instrument profile with the Thermo Fisher Cloud“ on page 38
• “Edit an instrument profile“ on page 37
• “Manage all instrument profiles (Administrator only)“ on page 37
Edit an instrument profile
In the home screen, touch
1.
Note: Administrators can also navigate to this screen by touching
Seings4Manage Users4Manage Proles.
Touch Edit.
2.
Select the elds to edit, then make changes.
3.
Touch Done.
4.
My Prole.
Manage all instrument profiles (Administrator only)
In the home screen, access the All Proles tab.
1.
• Touch My Prole4All Proles.
• Touch Seings4Manage Users4Manage Proles4All Proles.
A list of users, the date the prole was created, and the user type displays.
Select the instrument prole to edit.
2.
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Chapter 3 Configure the instrument and manage instrument profiles
3
Link an instrument profile with the Thermo Fisher Cloud
Edit the prole.
3.
• To delete the prole, touch Delete prole4Delete.
• To reset the PIN, touch Reset PIN4Reset.
– The user will be directed to enter a new PIN at the next sign in.
• To enable or disable administrative privileges, slide the control to
Administrator or Standard, respectively.
Touch Done.
4.
Link an instrument profile with the Thermo Fisher Cloud
Linking your instrument prole with the Thermo Fisher Cloud allows you to access the following functions:
• View an instrument status from the Cloud.
• Download templates from your Cloud storage to the instrument.
• Transfer run data from the instrument to your Cloud storage.
Link an existing instrument profile with the Thermo Fisher Cloud
Create a new instrument profile and link with the Thermo Fisher Cloud
To link an instrument prole with the Thermo Fisher Cloud, see the following sections:
• “Link an existing instrument prole with the Thermo Fisher Cloud“
• “Create a new instrument prole and link with the Thermo Fisher Cloud“
Sign in to your instrument prole. See “Sign in“ on page 21.
1.
Touch
2.
Touch Cloud.
3.
Enter your username and password, then touch Link Account.
4.
Touch Done.
5.
Your instrument prole is linked with the Thermo Fisher Cloud.
Select an option to create a new instrument prole.
1.
• Create an administrator prole (see “Create an administrator instrument
• Create an instrument prole (see “Create a new instrument prole“ on
My Prole.
prole during initial start-up“ on page 27).
page 27).
38
In the Get Started – Cloud screen, enter your username and password.
2.
Touch Link Account.
3.
Your instrument prole is linked with the Thermo Fisher Cloud.
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4
Workflow
Create and run experiments on the
instrument
Workow ........................................................... 39
Run an experiment ................................................... 40
Edit an experiment before starting a run ................................. 41
View, pause, or stop a run ............................................. 46
Transfer EDS les from the instrument home screen ...................... 48
Start the instrument
(Optional)
Load an existing experiment template (EDT file)
Create an experiment template (EDT file)
Start the run from the instrument or the desktop software
(Optional)
Transfer results (EDS file) to the desktop or cloud software and analyze
Sign in to your instrument profile
(Optional)
Modify experiment settings as needed
Load the plate in the instrument
Link to your Cloud account
Monitor the run from the cloud software
or
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Chapter 4 Create and run experiments on the instrument
4

Run an experiment

Run an experiment

Create and run an experiment from a template

1.
2.
3.
4.
5.
6.
In the home screen, touch Open Template.
(Optional) Touch a category in the left column.
Touch the le name.
(Optional) Enter or edit template properties, including Run File Name (EDS le name), Plate Barcode, Reagent Information, and Data Destination (see “Enter or edit template properties“).
(Optional) Edit the run method (see “Edit the run method“ on page 43).
• Add, remove, or edit a step, stage, melt curve, or data collection point.
• Adjust the heated cover temperature, sample volume, or number of cycles.
Congure ramp rate and pause seings.
(Optional) Dene plate wells with sample names and view Well ID, Targets, or Dyes (see “Dene, assign, and view well details“).
Run an experiment from a saved file
Load a plate into the instrument (see “Load and unload a plate in the
7.
QuantStudio™ 1 Real-Time PCR Instrument“ on page 22).
Touch Start Run.
8.
When prompted, conrm that you inserted a plate.
Note: To disable this reminder, select Do not show again or select
Seings4Insert Plate Reminder in the home screen.
In the home screen, touch Load Experiment.
1.
Touch the appropriate icon to navigate to your le location.
2.
• For les saved to the guest prole, touch My Instrument4Public.
• For pre and post read les, touch My Instrument4Post Read.
Touch the le name.
3.
(Optional) Manage templates in either USB or My Instrument (see
4.
“Manage templates (EDT les)“).
(Optional) Enter or edit template properties, including Run File Name (EDS le
5.
name), Plate Barcode, Reagent Information, and Data Destination (see “Enter or edit template properties“).
40
(Optional) Edit the run method (see “Edit the run method“ on page 43).
6.
• Add, remove, or edit a step, stage, melt curve, or data collection point.
• Adjust the heated cover temperature, sample volume, or number of cycles.
Congure ramp rate and pause seings.
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Chapter 4 Create and run experiments on the instrument
(Optional) Dene plate wells with sample names and view Well ID, Targets, or
7.
Dyes (see “Dene, assign, and view well details“).
Load a plate into the instrument (see “Load and unload a plate in the
8.
QuantStudio™ 1 Real-Time PCR Instrument“ on page 22).
Touch Start Run.
9.
When prompted, conrm that you inserted a plate.
Note: To disable this reminder, select Do not show again or select
Seings4Insert Plate Reminder in the home screen.

Edit an experiment before starting a run

4

Repeat the last instrument run

This feature applies only to runs started from the instrument and is not available for runs started from the desktop software. If you are signed-in, this feature applies to the last run from your instrument prole.
In the home screen, touch Run Last.
1.
(Optional) Enter or edit template properties, including Run File Name (EDS le
2.
name), Plate Barcode, Reagent Information, and Data Destination (see “Enter or edit template properties“).
(Optional) Edit the run method (see “Edit the run method“ on page 43).
3.
• Add, remove, or edit a step, stage, melt curve, or data collection point.
• Adjust the heated cover temperature, sample volume, or number of cycles.
Congure ramp rate and pause seings.
(Optional) Dene plate wells with sample names and view Well ID, Targets, or
4.
Dyes (see “Dene, assign, and view well details“).
Load a plate into the instrument (see “Load and unload a plate in the
5.
QuantStudio™ 1 Real-Time PCR Instrument“ on page 22).
Touch Start Run.
6.
When prompted, conrm that you inserted a plate.
Note: To disable this reminder, select Do not show again or select
Seings4Insert Plate Reminder in the home screen.
Edit an experiment before starting a run

Enter or edit template properties

QuantStudio™ 1 Real-Time PCR System Installation, Use, and Maintenance Guide
Access a template (EDT le). For more information, see the following sections.
• “Create and run an experiment from a template“ on page 40.
• “Run an experiment from a saved le“ on page 40.
• “Repeat the last instrument run“ on page 41.
In the Properties screen, touch Edit to enter or edit template properties.
• Edit the le name for the EDS le for the run.
Touch the Run File Name eld.
a.
41
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Chapter 4
4
Edit an experiment before starting a run
Create and run experiments on the instrument
Enter the name for the EDS le, then touch Done.
b.
• Enter a plate barcode.
Touch the Plate Barcode eld.
a.
Enter or scan the plate barcode, then touch Done.
b.
• Record reagents and their expiration dates.
Touch
a.
Touch Add, or touch an existing reagent, then touch Edit or Delete.
b.
Touch the Name, Type, Lot #, Reagent Barcode, Part #, or Expiration Date
c.
eld to enter individual reagent information.
Touch Done.
d.
• Automatically transfer run data (EDS le) when an instrument run ends.
Touch Data Destination.
a.
Reagent Information.
Touch the appropriate icon to select a data destination.
b.
Under the desired data destination, select Automatically transfer
c.
experiment.
Touch Done.
d.
• Enter a comment.
Touch Comments.
a.
Enter text, then touch Done.
b.
Scan a barcode using the optional barcode scanner
The instrument is compatible with an optional Handheld Barcode Scanner (Cat. No. 4488442, purchased separately). The barcode scanner reads Code 128 (alphanumeric), which supports 128 ASCII character barcodes.
Click the Barcode eld.
1.
Hold the scanner 20–30 cm away from a plate or container label and aim at the
2.
center of the barcode, then press the trigger.
Slowly move the scanning beam across the barcode until the scanner emits a
3.
high-pitched tone.
42
When the scanner scans a barcode, it automatically transmits the following information:
• Transmits the alphanumeric equivalent of the barcode to the barcode eld.
• Transmits other reagent information (Lot #, Part #, Expiration Date, etc.)
For more information about the hand-held barcode scanner, see the user documentation provided with the barcode scanner.
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2
3
1
4
5
9
8
7
6
Chapter 4 Create and run experiments on the instrument
Edit an experiment before starting a run
4

Edit the run method

Access a template (EDT le). For more information, see the following sections.
• “Create and run an experiment from a template“ on page 40.
• “Run an experiment from a saved le“ on page 40.
• “Repeat the last instrument run“ on page 41.
For an overview of the method as it is graphically represented on the touchscreen, see “Method elements“ on page 43.
In the Method screen, touch Edit.
1.
Touch a eld, enter changes, then touch Enter.
2.
Note: Touch–drag to quickly increase or decrease a step temperature.
Touch “Manage steps, stages, melt curves, and data collection points“ to add or
3.
remove a step, stage, melt curve, or data collection point.
Note: The Manage Steps screen also provides access to conguring Ramp Rates and Add Pause seings. See “Congure ramp rates and pause seings“ on page 45.
Method elements
1
Method tab
2
Heated cover temperature
3
Reaction volume
4
Stage of thermal protocol
5
Step within a stage
6
Number of cycles for the stage
7
Temperature for the step
8
Hold time for the step
9
Data collection point
Manage steps, stages, melt curves, and data collection points
Add or remove a step, stage, melt curve, or data collection point using the Manage Steps option. You can also congure ramp rates and pause seings from the Manage Steps screen (see “Congure ramp rates and pause seings“ on page 45).
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Chapter 4 Create and run experiments on the instrument
4
Edit an experiment before starting a run
• In the Method screen, touch Edit4Manage Steps.
Option Procedure
Add a step
1. Touch Add/Remove steps4Add steps.
2. Touch on the left or right border of a step to add a step before or after the step, respectively.
3. Enter parameters for the new step, then touch Enter.
4. Touch Done.
Remove a step
Add a stage
Remove a stage
Add a melt curve
Remove a melt curve
1. Touch Add/Remove steps4Remove steps.
2. Touch on the step to be removed, then touch Done.
1. Touch Add/Remove stages4Add stages.
2. Touch on the left or right border of a stage to add a stage before or after the stage, respectively.
3. Edit parameters of the new stage in the Method screen. See “Edit the run method“ on page 43.
4. Touch Done.
1. Touch Add/Remove stages4Remove stages.
2. Touch on the stage to be removed, then touch Done.
1. Touch Melt curves4Add melt curve.
2. Touch on the left or right border of a step to add a melt curve before or after the step, respectively.
3. Select Continuous or Step and hold.
4. Touch melt curve parameters to edit, then touch Done.
5. Touch Done.
Note: Depending on the experiment type, there can be restrictions on the addition or placement of melt curves.
1. Touch Remove melt curve.
2. Touch on the melt curve to be removed, then touch Done.
44
Add or remove data collection points
QuantStudio™ 1 Real-Time PCR System Installation, Use, and Maintenance Guide
1. Touch Data collection location.
2. Touch to switch data collection on or off.
Page 45
Chapter 4 Create and run experiments on the instrument
Edit an experiment before starting a run
Configure ramp rates and pause settings
• In the Method screen, touch Edit4Manage Steps4Advanced Options.
Option Procedure
1. Touch Ramp Rates.
Edit Ramp Rates
Add a pause
2. Touch the ramp rates fields.
3. Touch Enter.
4.
(Optional)
1. Touch Add Pause.
2. Touch in a stage.
3. Enter the pause temperature, and the cycle after which the pause will occur.
4. Touch Enter.
5. The pause is represented by a P in the corner of the stage.
6. Touch Done.
Edit additional steps, then touch Done.
4
Define, assign, and view well details
Access a template (EDT le). For more information, see the following sections.
1.
• “Create and run an experiment from a template“ on page 40.
• “Run an experiment from a saved le“ on page 40.
• “Repeat the last instrument run“ on page 41.
In the Plate screen, dene, assign, and view well details.
2.
Option Procedure
Define and assign samples in the plate layout view
1. Touch .
2. Touch Manage or touch an individual well.
3. Touch the Samples subtab.
4. Select one or more wells, then touch Edit.
5. Enter sample names for the selected wells, then touch Done.
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Chapter 4 Create and run experiments on the instrument
4

View, pause, or stop a run

Option Procedure
Define and assign samples in the well table view
View target information
Touch Done to return to the Plate tab.
3.
View, pause, or stop a run
Do any of the following actions during an instrument run.
• View real-time data and plots (see “View real-time data and plots on the instrument touchscreen“ on page 46).
• Adjust the display of real-time plots (see “Adjust the display of real-time plots on the instrument touchscreen“ on page 47).
– Touch or swipe left once to view real-time run method information or to
edit the number of cycles.
– Touch or swipe left twice to view real-time data and plots.
• Pause or stop an instrument run (see “Pause or stop an instrument run“ on page 47).
1. Touch .
2. Touch Edit to edit sample names for individual wells.
3. Touch a sample name field, enter a new name, then touch Done.
1. Touch .
2. Touch Manage or touch an individual well.
3. Touch the Targets subtab.
4. Touch Details to view target information, then touch Done.

View real-time data and plots on the instrument touchscreen

46
In the instrument home screen, during an instrument run, touch or swipe left
1.
twice.
Touch Well details.
2.
Touch Samples, Targets, or Tasks to select a graphical representation of each
3.
selection.
Touch Close to return to the home screen.
4.
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Adjust the display of real-time plots on the instrument touchscreen

Chapter 4 Create and run experiments on the instrument
In the instrument home screen, during an instrument run, touch or swipe left
1.
twice to view real-time data and plots.
Touch Zoom.
2.
Touch
3.
Touch the arrows to pan left, right, up, or down on the graph.
4.
Touch Close to return to the default view.
5.
or to zoom in or out.
View, pause, or stop a run
4

Pause or stop an instrument run

Lock the touchscreen during a run

In the home screen, during an instrument run, touch
1.
real-time run method information.
Stop or pause the run.
2.
• Touch Stop Run.
• Touch Pause, then enter a pause temperature.
(Optional) After pausing a run, touch Edit to change the number of cycles.
3.
(Optional) After pausing a run, touch Unlock drawer to access the plate.
4.
or swipe left once to view
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation,
the plate temperature can reach 100°C. If you want to access the plate during a run pause, enter room temperature as the pause temperature and allow the plate to cool to room temperature before handling.
After you have started a run, you can lock the touchscreen so that other users cannot interfere with instrument operation.
Note: You must be signed-in to use this feature.
Lock the touchscreen.
1.
In the home screen, touch My Prole.
a.
Touch Lock Screen, then touch Lock.
b.
Unlock the touchscreen.
2.
Touch anywhere on the touchscreen.
a.
Touch the PIN Code eld, then enter your PIN.
b.
Note: The touchscreen automatically unlocks when the run is complete.
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Chapter 4 Create and run experiments on the instrument
4
Transfer EDS files from the instrument home screen
Transfer EDS files from the instrument home screen
In the home screen, when a run ends, touch Transfer File.
1.
Select the data destination for the EDS le.
2.
Navigate to and select a folder.
3.
Touch OK.
4.
Touch Transfer.
5.
Note: Touch Seings4Run History to transfer EDS les at any time.
48
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Page 49
Calibrate and verify instrument
5
Calibration and verication schedule ................................... 49
Calibration descriptions ............................................... 50
View the calibration status and set reminders ............................ 51
Perform ROI/uniformity, background, and dye calibrations ................ 52
Perform instrument verication using RNase P plates ..................... 57
Calibrate custom dyes ................................................ 62
Calibrate for a custom melt curve experiment ............................ 68
Calibration and verification schedule
performance
The instrument is factory-calibrated and does not require calibration at installation. To ensure optimal performance, perform calibrations at the recommended frequency.
Note: After instrument installation, we recommend performing instrument verication using the provided RNase P plate.
IMPORTANT! Perform calibrations and instrument runs under the environmental
conditions that are specied in “Environmental requirements“ on page 89. Exposure to extreme temperatures can adversely aect the instrument performance and shorten the life span of the instrument components.
To set the calibration frequency for the instrument, touch Seings4Maintenance and Service4Calibrations4History and Reminders4Edit4Exp interval eld.
Calibration
ROI/Uniformity
• Every two years (recommended)
• Always perform new Background and Dye calibrations after an ROI/Uniformity calibration.
Note: Performing an ROI/Uniformity calibration invalidates all other calibrations.
Recommended frequency
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Chapter 5 Calibrate and verify instrument performance
5

Calibration descriptions

Calibration Recommended frequency
Background
Dye
RNase P instrument
verification
• Every two years (recommended)
• Background calibration can also be performed, as needed: – To check for contamination (depends on usage and
laboratory conditions).
– To obtain the most accurate data for the removal of
background fluorescence.
Note: Performing a Background calibration does any other calibration.
• Every two years (recommended)
• During a Dye calibration, only the dyes on the given spectral
calibration plate are calibrated.
Note: Performing a Dye calibration for a given dye plate does invalidate any other calibration.
• After installing or moving the instrument
• After performing instrument calibrations
• As needed to confirm instrument performance
not
invalidate
Note: To prepare custom dye plates and to perform custom calibrations, see “Calibrate custom dyes“ on page 62.
not
Calibration descriptions
Calibration description and purpose
ROI/Uniformity
• The software captures images for each optical filter.
• The software uses calibration data to map the increase in fluorescence to the plate wells during subsequent runs and to evaluate well-to-well consistency of the signals.
Background
• The software captures background images for each optical filter in the absence of sample and reagent, and it checks that the fluorescence from each well is below a fluorescence threshold.
• The software uses calibration data to remove background fluorescence during a run.
Note: You can also run this calibration to determine if contamination is related to the sample block or the plate.
Pass Criteria
The image for each filter distinguishes all wells of the plate.
Each well in the image is distinct.
The plate images for all filters are free of abnormal fluorescence.
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Chapter 5 Calibrate and verify instrument performance

View the calibration status and set reminders

5
Calibration description and purpose
Dye
• The software extracts a spectral profile for each dye standard, then produces a set of spectral profiles plotted as fluorescence vs filter.
• The software uses calibration data to characterize and distinguish the individual contribution of each dye in the total fluorescence signals collected by the instrument.
View the calibration status and set reminders
In the home screen, touch Seings4Maintenance and

View calibration status and set reminders in the instrument

1.
Service4Calibrations4History and Reminders.
In the Calibration Reminders screen, view the status of each calibration type.
2.
(Optional) Touch a calibration row to view the history of that specic calibration
3.
type, then touch Done.
Touch Edit to set the calibration reminder seings. For each calibration type:
4.
Slide the control On to enable the calibration reminder.
a.
Pass Criteria
Dye spectra peak within the same filter as their group.

View calibration status and set reminders in the Cloud

Edit the Exp interval and Remind me elds.
b.
Touch Save.
c.
(Optional) To transfer the calibration report, touch Export then follow the
5.
directions on the screen.
Touch Done.
6.
Note: The calibration reminders feature requires a connection between the
instrument and a computer network.
In the Thermo Fisher Cloud, click
1.
Select any of your registered instruments.
2.
In the Summary tab:
3.
• Click Calibrations to view the status of each calibration type.
(Optional) Click Calibration Reminders to set the calibration reminder
time table and enter the notication email address(es).
Note: More than one email address can receive the calibration reminders.
Note: The seings are automatically saved.
(Optional) In the Downloads section, click Maintenance Summary.pdf to
download the calibration status report.
for the Instrument Connect page.
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Chapter 5 Calibrate and verify instrument performance
5
Perform ROI/uniformity, background, and dye calibrations
In the Calibrations History tab:
4.
• View the history of each calibration type.
(Optional) Click to download the calibration history report.
Perform ROI/uniformity, background, and dye calibrations
Workflow:
Calibration

Prepare a calibration plate

Perform an ROI/uniformity calibration
You are automatically prompted to perform background calibration.
Perform a background calibration
Perform any time that ROI/uniformity calibrations are current.
Perform system dye calibrations
Perform any time that ROI/uniformity and background calibrations are current.
(
Optional
Perform any time that ROI/uniformity and background calibrations are current.
) Perform custom dye calibrations (“Calibrate custom dyes“ on page 62)
Materials required for calibration plate preparation
• Plate(s) for the calibration that you are performing: – ROI/Uniformity plate (one ROI plate needed)
– Background calibration plate
– Dye calibration plates
52
Note: We recommend calibrating with all Spectral Dye Calibrations Plates
available for your block conguration even if you are not using all the dyes in the plates.
Note: Do not discard the packaging for the calibration plates. Each calibration plate can be used up to 3 times if the following conditions are met:
The plate is stored in its packing sleeve at –15 to –25°C.
·
The plate is used within 6 months after opening.
·
The plate is used before the plate expiry date
·
• Centrifuge with plate adapter; buckets cleaned before use
• Powder-free gloves
• Safety glasses
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Chapter 5 Calibrate and verify instrument performance
Perform ROI/uniformity, background, and dye calibrations
Thaw, vortex, and centrifuge a calibration plate
Remove the calibration plate from the freezer, then thaw the plate in its
1.
packaging. Keep plates protected from light until you perform the calibration.
• Thaw each plate for 30 minutes.
• Use each plate within 2 hours of thawing.
IMPORTANT! Do not remove the plate from its packaging until you are ready to
use it. The uorescent dyes in the wells of calibration plates are photosensitive. Prolonged exposure to light can diminish the uorescence of the dyes.
While wearing powder-free gloves, remove the calibration plate from its
2.
packaging and retain the packaging. Do not remove the optical lm.
Vortex the plate for 5 seconds, then centrifuge at 750–1,000 × g for 2 minutes.
3.
Conrm that the liquid in each well is at the boom of the well and free of
4.
bubbles. If it is not, centrifuge the plate again.
5

Perform calibrations

IMPORTANT! Keep the boom of the plate clean. Fluids and other contaminants
on the boom of the plate can contaminate the sample block and cause an abnormally high background signal.
In the home screen, select a calibration to perform.
1.
Calibration Touch
ROI/Uniformity
Background
Dye Settings4Maintenance and Service4Calibrations4Dye
[1]
Automatically followed by Background calibration.
[2]
Initiate via this route if performing Background calibration only.
Follow the instructions on the screen to start the calibration.
2.
[1]
[2]
Settings4Maintenance and Service4Calibrations4ROI and
Uniformity
Settings4Maintenance and
Service4Calibrations4Custom4Background
Note: Dye calibration only: Select the Dye Plate to run, then touch Next.
Load the plate into the instrument.
3.
Touch Start.
4.
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Chapter 5 Calibrate and verify instrument performance
5
Perform ROI/uniformity, background, and dye calibrations
When the run is complete and the screen displays Calibration Complete, touch
5.
View Results to check the calibration status.
Calibration status Action
Passed Touch Next to proceed to the next required calibration.
Failed See “Troubleshoot calibration failure“ on page 55.
Note: You can view the calibration images only after the ROI/Uniformity and Background calibrations pass.
Unload the plate from the instrument.
6.
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation,
the plate temperature can reach 100°C. Allow it to cool to room temperature before handling.
Return the plate to its original packaging.
7.
Note: Each calibration plate can be used up to 3 times if the following conditions
are met:
The plate is stored in its packing sleeve at –15 to –25°C.
·
The plate is used within 6 months after opening.
·
The plate is used before the plate expiry date
·

View calibration images and transfer results to USB

The instrument performs the ROI, Uniformity, and Background calibrations in sequence. You can view the calibration images after the Background calibration is complete.
In the Calibration Status screen, touch Details.
1.
In the Details screen, touch a calibration type to view its images and plots.
2.
Calibration Example results indicating successful calibration
ROI
Note: Select the desired filter combination from the Filter Set dropdown list.
Green circles around all wells and bright well centers.
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Chapter 5 Calibrate and verify instrument performance
Perform ROI/uniformity, background, and dye calibrations
Calibration Example results indicating successful calibration
Uniformity Signals from each well following a uniform trend.
Background Few, if any, signals with abnormally high fluorescence.
Dye Signals from each well following a uniform trend, and
each dye peaks at the correct filter.
5
In the Calibration Status screen, touch Accept Results or Reject Results.
3.
Accepting the results saves the calibration data to the instrument and overwrites existing data.
(Optional) Touch Transfer EDS to transfer the calibration data to a USB.
4.

Troubleshoot calibration failure

Observation
Calibration failed The plate was improperly
prepared.
The plate is damaged or contaminated.
Possible cause Recommended action
Ensure the following:
• The correct plate was used for the calibration performed.
• The plate was properly thawed.
• The plate was properly centrifuged.
• The plate was properly sealed.
Check for damage, improper plate seal, or contamination.
Order a replacement plate. If the replacement plate fails, contact Support.
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Chapter 5 Calibrate and verify instrument performance
5
Perform ROI/uniformity, background, and dye calibrations
Observation Possible cause Recommended action
High fluorescence signal in individual wells
Calibration failed but plate is undamaged
Signals that exceed the limit of normal fluorescence may indicate fluorescent contaminants on the plate or the sample block.
The incorrect plate was used for calibration performed.
The plate was improperly prepared.
See “Identify contamination“ on page 56.
Use the plate that matches the calibration performed.
Repeat the calibration with the plate properly prepared.
If the calibration fails again, order a replacement plate. If the replacement plate fails, contact Support.

Identify contamination

Create a background plate
(optional)
Signals that exceed the limit of normal contaminants on the calibration plate or the sample block. Common contaminants include ink residue from permanent pens, powder from disposable gloves, and dust.
View the calibration data and note the wells that failed the calibration.
1.
Remove the plate from the instrument, rotate the plate 180°, then perform the
2.
calibration again.
Determine the location of the failed wells again as in step 1.
3.
Position of failed wells Action
Identical The sample block is contaminated.
Reversed The plate is contaminated.
If the calibration fails after you decontaminate the sample block and replace the
4.
plate, contact Support.
Whenever possible, use a background plate listed in Appendix D, “Parts and materials“. These plates contain a buer that accurately simulates the reagents used for PCR, and, therefore, produces high-quality calibration data.
If a background plate is not available, you can create one as described below.
uorescence may indicate uorescent
Decontaminate the sample block (see page 71).
Discard the plate, then perform the calibration using a new calibration plate.
56
Required materials:
• MicroAmp™ optical 96-well reaction plate
• Optical adhesive cover or optical at caps
Pipeor, 200-µL (with pipee tips)
• Powder-free gloves
• Safety glasses
• Deionized water
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Chapter 5 Calibrate and verify instrument performance
Perform instrument verification using RNase P plates
IMPORTANT! Wear powder-free gloves while creating the background plate.
Remove a reaction plate from its box and place it on a clean, dry surface.
1.
Aliquot 50 µL of deionized water to each well of the reaction plate.
2.
Seal the plate using an optical adhesive cover or optical at caps.
3.
Use the plate for background calibration.
4.
Perform instrument verification using RNase P plates
Instruments are factory-calibrated, so calibration is not necessary for initial installation. However, perform instrument verication:
• After installation and before rst use of the instrument.
• After performing instrument calibrations.
• As needed to conrm instrument performance.
5
The instrument requires valid ROI/uniformity, background, and dye calibrations to perform instrument verication.
Instrument verification description
Purpose
Confirms the performance of the instrument.
Quantifies the number of copies of the human RNase P gene in samples with known concentrations of the corresponding DNA template.
Description Pass criteria
The instrument passes performance specifications if the following inequality is true and the instrument successfully distinguishes between unknown populations A and B with a statistical confidence level of 99.7%.
[(CtA) – 3(σ
where:
• CtA = Average Ct of unknown population A
• σ
CtA
population A
• CtB = Average Ct of unknown population B
• σ
CtB
population B
)] > [(CtB) + 3(σ
CtA
= Standard deviation of unknown
= Standard deviation of unknown
CtB
)]
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4
2
5
76
3
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Chapter 5 Calibrate and verify instrument performance
5
Perform instrument verification using RNase P plates
RNase P instrument verification plate
The RNase P plate contains the reagents necessary for the detection and quantitation of genomic copies of the human RNase P gene (a single-copy gene encoding the RNase moiety of the RNase P enzyme). Each well contains: PCR master mix, RNase P primers, FAM™ dye-labeled probe, and a known concentration of human genomic DNA template.
Figure 1 96-well RNase P plate
1
Unknown A (5,000)
2
NTC (no template control)
3
STD 1,250 copies
4
STD 2,500 copies
5
STD 5,000 copies
6
STD 10,000 copies
7
STD 20,000 copies
8
Unknown B (10,000)
Performance
specifications
pass criteria

Prepare an RNase P plate

After the run, the software calculates average copy number values and standard deviation values. The instrument passes performance specications if the following inequality is true and the instrument successfully distinguishes between unknown populations A and B with a statistical condence level of 99.7%.
[(CtA) – 3(σ
)] > [(CtB) + 3(σ
CtA
CtB
)]
where:
• CtA = Average Ct of unknown population A
• σ
= Standard deviation of unknown population A
CtA
• CtB = Average Ct of unknown population B
• σ
= Standard deviation of unknown population B
CtB
The software automatically adjusts the threshold and omits a dened number of wells from the unknown populations to meet the performance specications. To view any omied wells, open the EDS le for the verication in the desktop software.
Materials required for RNase P plate preparation
• RNase P instrument verication plate
• Centrifuge with plate adapter; buckets cleaned before use
• Powder-free gloves
• Safety glasses
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Perform instrument verification using RNase P plates
Thaw, vortex, and centrifuge an RNase P plate
IMPORTANT! Expose the RNase P plate to room temperature for no more than
45 minutes, inclusive of thawing and preparation time.
After thawing, the RNase P plate cannot be refrozen.
Remove the RNase P plate from the freezer, then thaw the plate in its packaging.
1.
• Thaw the plate for approximately 5 minutes.
• Use the plate within 30 minutes of thawing.
Conrm that the bench, vortex, and centrifuge are clean. Before use, wipe the
2.
vortex and centrifuge using a lint-free tissue.
While wearing powder-free gloves, remove the plate from its packaging.
3.
Vortex the plate for 5 seconds, then centrifuge at 750–1,000 × g for 2 minutes.
4.
Conrm that the liquid in each well is at the boom of the well and free of
5.
bubbles. If it is not, centrifuge the plate again.
5
Perform RNase P
verification
IMPORTANT! Keep the boom of the plate clean. Fluids and other contaminants
on the boom of the plate can contaminate the sample block and cause an abnormally high background signal.
In the home screen, touch Seings4Maintenance and Service4RNase P
1.
Verication.
Load the plate into the instrument.
2.
Touch Start.
3.
When the run is complete and the screen displays Verication Complete, touch
4.
View Results to conrm the status of the run.
Calibration status Action
Passed Instrument is ready for use.
Failed See “Troubleshoot verification failure“ on page 61.
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Chapter 5 Calibrate and verify instrument performance
5
Perform instrument verification using RNase P plates
In the RNase P Verication Status screen, touch one of the following options:
5.
Accept Results — Save the results to the instrument.
Reject Results — Delete the RNase P verication results.
Export Results — Export the calibration results to a USB.
Unload the plate from the instrument.
6.
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation,
the plate temperature can reach 100°C. Allow it to cool to room temperature before handling.
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Troubleshoot verification failure
Observation Possible cause Recommended action
Verification failed The plate was improperly
prepared.
The plate is damaged or contaminated.
High fluorescence signal The reaction volume is not
correct.
Signals that exceed the limit of normal fluorescence may indicate fluorescent contaminants on the plate or the sample block.
Chapter 5 Calibrate and verify instrument performance
Perform instrument verification using RNase P plates
Ensure the following:
• The correct plate was used for the verification performed.
• The plate was properly thawed.
• The plate was properly centrifuged.
• The plate was properly sealed.
Open the EDS file for the verification in the desktop software or cloud software to view the flags and troubleshooting details for failed wells.
Check for damage, improper plate seal, or contamination.
Order a replacement plate. If the replacement plate fails, contact Support.
Ensure that reaction volumes in the plate are correct and match the volume that is entered in the Method tab.
Examine the bottom of the reaction plate. If there is contamination, prepare a new plate and run the experiment again.
Identify the location of contamination on the plate or sample block.
5
Verification failed but plate is undamaged
The incorrect plate was used for verification.
The plate was improperly prepared.
1. Obtain or prepare a background plate (see page 56).
2. Follow the procedures that are described in “Identify contamination“ on page 56.
Use the correct RNase P plate for verification.
Repeat the verification with a new properly prepared plate.
Note: The verification procedure is an experiment run, so each RNase P plate can only be used once.
Open the EDS file for the verification in the desktop software or cloud software to view the flags and troubleshooting details for failed wells.
If the verification fails again, order a replacement plate. If the replacement plate fails, contact Support.
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Chapter 5 Calibrate and verify instrument performance
5

Calibrate custom dyes

Calibrate custom dyes

Custom dyes overview

The instrument can run assays designed with custom dyes. Custom dyes include:
• Dyes that are not manufactured by Thermo Fisher Scientic.
• Dyes or formulations of dyes that are not system dyes for the instrument.
• For custom dye requirements, see “Custom dyes“ on page 10.
Workflow: Custom dye calibration
For each custom dye, determine the optimal dye concentration. Use this concentration to prepare all subsequent dye calibration plates.

Use a dilution series to determine an optimal custom dye concentration

“Prepare a custom dye dilution plate“ on page 63
“Run the dilution plate as an experiment“ on page 64
“Determine the optimal dye concentration“ on page 64
Calibrate the custom dye using the optimal concentration
Create a custom dye calibration plate
Use a dilution series to determine an optimal custom dye concentration
Add a custom dye to the instrument
“Perform a custom dye calibration“ on page 66
Custom dye dilution guidelines
Prepare a dilution series for each custom dye.
• Target several dye concentrations within a range of 100–2,000 nM.
• Choose a 2- or 3-fold dierence in dilution points.
• Dispense 10–20 µL per well in a 96-well plate.
• Dilute the dye in buer compatible with your master mix.
(Intercalating dyes only) Add the appropriate amount of amplied PCR product to generate uorescence.
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100 nM
200 nM
400 nM
800 nM
1600 nM
Chapter 5 Calibrate and verify instrument performance
Calibrate custom dyes
Prepare a custom dye dilution plate
IMPORTANT! Wear powder-free gloves throughout the procedure.
Prepare a 2- or 3-fold dilution series of the custom dye.
1.
Dispense aliquots of each dilution into the center of a reaction plate, then seal the
2.
plate.
A full plate is not needed. See the following gure for suggested replicates.
5
Vortex the plate for 5 seconds, then centrifuge at 750–1,000 × g for 2 minutes.
3.
Conrm that the liquid in each well is at the boom of the well and free of
4.
bubbles. If it is not, centrifuge the plate again.
IMPORTANT! Keep the boom of the plate clean. Fluids and other contaminants
on the boom of the plate can contaminate the sample block and cause an abnormally high background signal.
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Chapter 5
5
Calibrate custom dyes
Calibrate and verify instrument performance
Run the dilution plate as an experiment
Load the plate into the instrument.
1.
Set up a genotyping experiment on the instrument.
2.
• Load an experiment created in the desktop software.
a. In the home screen, touch Load Experiment.
b. Select the experiment location, then the experiment le.
• Create a new experiment on the instrument touchscreen.
a. In the home screen, touch Open Template4Genotyping4Genotyping
Post.
b. (Optional) In the Properties tab, edit the experiment properties.
c. In the Method tab, set the hold temperature to 60°C with a 2 minute hold
and enter the appropriate reaction volume.
d. In the Plate tab, enter the dilution series information for the appropriate
wells.
Touch Start Run.
3.
When the run is complete, download the results for analysis.
4.
Unload the plate from the instrument.
5.
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation,
the plate temperature can reach 100°C. Allow it to cool to room temperature before handling.
Determine the optimal dye concentration
Review the dye signal data and select the dilution to use for dye calibrate.
In the Results tab of the desktop software, select Raw Data Plot.
1.
This plot displays the raw uorescence signal of each optical lter, for individual wells.
Note: The Raw Data Plot cannot be viewed on the instrument touchscreen.
For each replicate population of dilutions, select the wells in the Plate Layout to
2.
view in the plot.
Examine the raw data to identify the wells yielding signals in the 800,000 to
3.
3,200,000 range for the optical lter where the dye is brightest.
(Optional) Export the raw data, then calculate the average uorescence value for
4.
each concentration.
64
Select the lowest (optimal) dye concentration that falls within the acceptable
5.
signal range.
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Chapter 5 Calibrate and verify instrument performance
Calibrate custom dyes
5

Calibrate the custom dye

Create a custom dye calibration plate
IMPORTANT! Wear powder-free gloves while creating the dye plate.
Create a full plate of the custom dye diluted to the optimal concentration:
Dilute the custom dye to the optimal concentration in buer.
1.
Prepare an adequate volume, using a volume range of 10–20 µL/well for a 96-well plate.
Pipet the appropriate volume of the diluted custom dye to the plate wells.
2.
Seal the plate.
3.
Vortex the plate for 5 seconds, then centrifuge at 750–1,000 × g for 2 minutes.
4.
Conrm that the liquid in each well is at the boom of the well and free of
5.
bubbles. If it is not, centrifuge the plate again.
IMPORTANT! Keep the boom of the plate clean. Fluids and other contaminants
on the boom of the plate can contaminate the sample block and cause an abnormally high background signal.
Add a custom dye to the instrument
In the instrument home screen, touch
1.
Service4Calibrations4Custom4Custom Dye.
Touch Add Custom Dye.
2.
Seings4Maintenance and
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Chapter 5 Calibrate and verify instrument performance
5
Calibrate custom dyes
Enter the dye information:
3.
Field/option Action
Custom Dye Name
Type Select:
Touch Save.
4.
Enter a name for the custom dye.
IMPORTANT!
Do not use a system dye name for a custom dye name.
·
Dye names are spacing sensitive and cannot contain special
·
characters.
Reporter—The dye works in conjunction with a quencher dye to report an increase of PCR product.
Quencher—The dye suppresses the fluorescence of a reporter dye until amplification of PCR product.
Both—The dye can be used as a reporter or quencher dye.
IMPORTANT! You must also add the custom dye to the desktop software dye library
before creating, running, or analyzing experiments that use custom dyes. For detailed information, see the QuantStudio™ Design and Analysis Software help.
Perform a custom dye calibration
Load the plate into the instrument.
1.
In the instrument home screen, touch
2.
Service4Calibrations4Custom4Custom Dye.
Touch the custom dye to calibrate.
3.
Review the custom dye information, (optional) make changes, then touch Update.
4.
Enter the calibration temperature.
5.
(Optional) Touch Reagents, then enter reagent information.
6.
Touch Start.
7.
When the run is complete and the screen displays Calibration Complete, touch
8.
View Results4Details.
Seings4Maintenance and
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Review the plot. Passing calibration results show uniform signals with peaks that
9.
Calibrate custom dyes
are aligned with the dye wavelength.
Peak filter
x1-m1 470 ± 15 520 ± 15
x2-m2 520 ± 10 558 ± 12
x4-m4 580 ± 10 623 ± 14
[1]
The central wavelengths are the optimized wavelengths.
Figure 2 Example dye calibration plot
Note: The peaks for your dye may align with a different filter set.
Filter wavelength (nm)
Excitation Emission
[1]
5
Select an action depending on whether the custom dye calibration passed or
10.
failed.
Calibration status Action
Passed
Failed
Unload the plate from the instrument.
11.
• Touch Accept Results or Reject Results.
Note: Accepting the results saves the calibration data to the instrument and overwrites existing data.
• (
Optional
data to a USB.
• Perform the calibration again using a new custom dye plate. Create the plate using the next dye concentration greater than the optimal dye concentration determined in “Use a dilution series to determine an optimal custom dye concentration“ on page 62
• See “Troubleshoot calibration failure“ on page 55.
) Touch Transfer EDS to transfer the calibration
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation,
the plate temperature can reach 100°C. Allow it to cool to room temperature before handling.
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5

Calibrate for a custom melt curve experiment

Calibrate for a custom melt curve experiment
Note: A custom melt calibration calibrates a custom dye and a melt calibration at the same time.
Before running the custom melt calibration complete the following tasks:
• Ensure that all calibrations are current (touch Seings4Maintenance and Service4Calibrations4History and Reminders).
• Add a custom dye to the instrument (see “Add a custom dye to the instrument“ on page 65).
In the home screen, touch Seings4Maintenance and
1.
Service4Calibrations4Custom4Custom Melt.
Touch PCR + Melt or Melt only as appropriate for the kit you are using.
2.
Load the plate into the instrument.
3.
Select or add a dye, then select a lter set appropriate for your dye's wavelength
4.
(see lter-wavelength table below).
Note: Refer to your reagent kit documentation for dye name and wavelength information.
[1]
Peak filter
x1-m1 470 ± 15 520 ± 15
x2-m2 520 ± 10 558 ± 12
x4-m4 580 ± 10 623 ± 14
[1]
The central wavelengths are the optimized wavelengths.
Excitation Emission
Filter wavelength (nm)
IMPORTANT! If the selected lter set does not match your reagent kit
documentation, then the incorrect wavelength may be collected during a run.
(Optional) Touch Reagents, then enter reagent information.
5.
Touch Start.
6.
When the run is complete and the screen displays Calibration Complete, touch
7.
View Results4Details.
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Chapter 5 Calibrate and verify instrument performance
Review the plot. Passing calibration results show uniform signals with peaks that
8.
are aligned with the dye wavelength.
Figure 3 Example dye calibration plot
Note: The peaks for your dye may align with a different filter set.
Select an action depending on whether the custom dye calibration passed or
9.
failed.
Calibration status Action
Calibrate for a custom melt curve experiment
5
Passed
Failed
Unload the plate from the instrument.
10.
Note:
You must also add the custom dye to the QuantStudio™ Design and Analysis
·
Desktop Software dye library before creating, running or analyzing experiments that use custom dyes. To perform a custom melt experiment, you can either create a Standard Curve or a
·
Custom experiment with melt, then specify the data points per degree in the method.
• Touch Accept Results or Reject Results.
Note: Accepting the results saves the calibration data to the instrument and overwrites existing data.
• (
Optional
data to a USB.
• Perform the calibration again using a new custom dye plate. Create the plate using the next dye concentration greater than the optimal dye concentration determined in “Use a dilution series to determine an optimal custom dye concentration“ on page 62
• See “Troubleshoot calibration failure“ on page 55.
) Touch Transfer EDS to transfer the calibration
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Maintain the instrument

6
Backup or restore the instrument ....................................... 70
Decontaminate the sample block ....................................... 71
Replace the instrument fuses ........................................... 73
Prepare the instrument to store, move, or ship ........................... 74
IMPORTANT! This chapter contains user maintenance procedures for the instrument.
Procedures other than those described in this document must be performed by a qualied Thermo Fisher Scientic service representative.

Backup or restore the instrument

In the home screen, touch Seings4Maintenance and Service4Backup/Restore.
To Action
Backup
Restore (Administrator only)
1. Touch Backup Instrument.
2. Select a location to store the backup settings for your instrument.
3. If backing up to a USB, insert a USB into the front-panel USB port.
4. Enter a backup file name, then touch Done.
5. Select the elements to backup, or leave them all selected.
6. Touch Backup.
1. Touch Restore a Backup.
2. Select the storage location of the backup settings.
3. If restoring from a USB, insert a USB into the front-panel USB port.
4. Select the backup file, then touch Restore.
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Decontaminate the sample block

Perform this procedure to eliminate uorescent contaminants from the instrument sample block. Contamination is generally evident in failed background calibrations where one or more wells consistently exhibit abnormally high signals.
CAUTION! PHYSICAL INJURY HAZARD. Do not remove the instrument
cover. There are no components inside the instrument that you can safely service yourself. If you suspect a problem, contact Support.
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation, the
sample block temperature can reach 100°C. Allow it to cool to room temperature before handling.
CAUTION! Before using a cleaning or decontamination method other than
those recommended by Thermo Fisher Scientic, conrm with Thermo Fisher Scientic that the proposed method will not damage the equipment.
Chapter 6 Maintain the instrument
Decontaminate the sample block
6

Materials required

Clean the sample block

• Safety glasses
• Powder-free gloves
• Tissue, lint-free
Coon or nylon swabs and lint-free cloths
Pipee (100-µL) with pipee tips
• Deionized water
• Ethanol, 95% solution
• Bleach, 10% solution
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation, the
sample block temperature can reach 100°C. Allow it to cool to room temperature before handling.
IMPORTANT!
Wear powder-free gloves when you perform this procedure.
·
Always use deionized water to rinse wells after cleaning with bleach or ethanol
·
solution.
Identify the contaminated wells of the sample block (see “Identify
1.
contamination“ on page 56).
Prepare the instrument and access the sample block.
2.
Power o and unplug the instrument, then allow it to cool for 15 minutes.
a.
Pull the instrument drawer forward to expose the sample block.
b.
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Chapter 6
6
Decontaminate the sample block
Maintain the instrument
Rinse the contaminated wells with deionized water (see “Detailed procedures for
3.
cleaning the sample block“ on page 73).
Close the drawer and test the sample block for contamination.
4.
Push the instrument drawer back in to the instrument.
a.
Plug in, then power on the instrument.
b.
Perform a background calibration to conrm that you have eliminated the
c.
contamination.
If the contamination remains, clean the contaminated wells using a 95% ethanol
5.
solution.
Repeat step 2 – step 3.
a.
Clean the contaminated wells using a 95% ethanol solution (see “Detailed
b.
procedures for cleaning the sample block“ on page 73).
Repeat step 3 – step 4 to rinse the sample block with deionized water and to
c.
conrm that you have eliminated the contamination.
IMPORTANT! Always use deionized water to rinse wells after cleaning with
bleach or ethanol solution.
If the contamination remains, clean the contaminated wells using a 10% bleach
6.
solution.
Repeat step 2 – step 3.
a.
Clean the contaminated wells using a 10% bleach solution (see “Detailed
b.
procedures for cleaning the sample block“ on page 73).
Repeat step 3 – step 4 to rinse the sample block with deionized water and to
c.
conrm that you have eliminated the contamination.
72
IMPORTANT!
bleach or ethanol solution.
If the contamination continues to remain, contact Support.
7.
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Chapter 6 Maintain the instrument

Replace the instrument fuses

6

Detailed procedures for cleaning the sample block

IMPORTANT! Use these cleaning procedures only in conjunction with the complete
decontamination procedure (see “Decontaminate the sample block“ on page 71).
• Rinse the sample block with deionized water.
Pipet a small volume of deionized water into each contaminated well.
a.
In each well, pipet the water up and down several times to rinse the well.
b.
Pipet the water to a waste beaker.
c.
Use a coon swab to scrub inside of each contaminated well.
d.
Use a lint-free cloth to absorb the excess deionized water.
e.
• Clean the sample block with 95% ethanol.
Pipet a small volume of 95% ethanol solution into each contaminated well.
a.
In each well, pipet the solution up and down several times to rinse the well.
b.
Pipet the ethanol solution to a waste beaker.
c.
IMPORTANT! Always use deionized water to rinse wells after cleaning with
bleach or ethanol solution.
• Clean the sample block with 10% bleach.
Pipet a small volume of 10% bleach solution into each contaminated well.
a.
In each well, pipet the solution up and down several times to rinse the well.
b.
Pipet the bleach solution to a waste beaker.
c.
IMPORTANT! Always use deionized water to rinse wells after cleaning with
bleach or ethanol solution.
Replace the instrument fuses
CAUTION! FIRE HAZARD. For continued protection against the risk of re,
replace fuses only with listed and certied fuses of the same type and rating as those currently in the instrument.

Materials required

• Fuses (2) – 10A, Time-Lag T, 250VAC, 5 × 20mm
• Safety glasses
• Powder-free gloves
• Screwdriver, athead
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Chapter 6 Maintain the instrument
6

Prepare the instrument to store, move, or ship

Replace the fuses

Power o and unplug the instrument, then allow it to cool for 15 minutes.
1.
Using a at-head screwdriver, unscrew and remove the fuse holder.
2.
Remove each fuse from its fuse holder and inspect it for damage. Carbon
3.
typically coats the inside of failed fuses.
Good Failed
Replace each failed fuse.
4.
Note: The voltage and amperage ratings are on the fuse holder.
Install the fuse holder back into the instrument.
5.
Plug in, then power on the instrument.
6.
The installation is successful if the instrument powers on.
Note: Fuse failure can result from uctuations in the supplied power to the system. To prevent further failures, consider installing an electrical protective device, such as a UPS or a surge protector. If issues with the fuse persist, contact Support.
Prepare the instrument to store, move, or ship
In the home screen, touch
1.
Mode4Next.
Open the instrument drawer.
2.
Load the packing plate or an empty plate, then close the drawer.
3.
Touch Lock Block.
4.
Seings4Maintenance and Service4Ship Prep
74
Power o the instrument using the power switch on the back of the instrument.
5.
The instrument is now ready to store, move, or ship.
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Chapter 6 Maintain the instrument
Prepare the instrument to store, move, or ship
6

Move the instrument

CAUTION! PHYSICAL INJURY HAZARD. Do not aempt to lift the
instrument or any other heavy objects unless you have received related training. Incorrect lifting can cause painful and sometimes permanent back injury. Use proper lifting techniques when lifting or moving the instrument. At least two people are required to lift it.
IMPORTANT! Moving your instrument can create subtle changes in the alignment of
the instrument optics. Recalibrate the instrument if necessary.
• Ensure that the surface on which you place the instrument can support at least 35 kg (77 lbs).
• Ensure that the path to transport the instrument is clear of obstructions.
• At least two people are needed to lift and carry the instrument.
• Keep your spine in a good neutral position.
• Bend at the knees and lift with your legs.
• Do not lift an object and twist your torso at the same time.
• Coordinate your intentions with your assistant before lifting and carrying.
IMPORTANT! After moving the instrument, perform an RNase P instrument
verication run. If the run fails, perform ROI/ uniformity, background, and dye calibrations.

Return the instrument for service

The service process requires 2 to 3 weeks.
Before returning the instrument for service, perform the following tasks.
1. Back up the instrument (see “Backup or restore the instrument“ on page 70).
2. In the home screen, touch Seings4Instrument Seings4Reset Factory defaults.
3. Set the instrument to Ship Prep Mode (see “Prepare the instrument to store, move, or ship“ on page 74).
To return the instrument for service, perform the following tasks.
Contact your local customer care center or technical support group to obtain a
1.
copy of the Certicate of Instrument Decontamination, a service notication, a service call number, and packaging materials (if required).
Follow the instructions in the form to decontaminate the instrument.
2.
IMPORTANT! The instrument must be decontaminated before packing it for
shipping.
Complete and sign a copy of the Certicate of Instrument Decontamination.
3.
Fax the Certicate of Instrument Decontamination to the customer care center.
4.
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Chapter 6 Maintain the instrument
6
Prepare the instrument to store, move, or ship
Pack the instrument in the provided packaging and follow the instructions in the
5.
table below.
Prepare Include Exclude
1. Transfer any data files from the instrument.
2. Load an empty plate in the sample block.
3. Use the touchscreen to place the instrument in ship mode.
Note: The empty plate and ship mode protects the internal components of the instrument during transport.
Aach the postage provided with the Certicate of Instrument Decontamination
6.
• Instrument
• Completed and signed Certificate of Instrument Decontamination
Note: The instrument will not be accepted for service without a hard copy of the Certificate of Instrument Decontamination.
Any accessories, including:
• Power cord
• Ethernet cable
• USB drive
• Wireless adapter
Note: If included with the instrument, these items will be disposed of during service and not returned.
to the box, then ship the instrument to the designated facility.
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Install and connect the instrument
A
Workow: Install and connect to a network .............................. 77
Before you begin ..................................................... 78
Instrument and computer connections .................................. 78
Unpack and install the instrument ...................................... 79
Power on and follow the startup wizard ................................. 80
Connect the instrument and the computer directly or to a LAN ............. 80
Networking ......................................................... 81
Workflow: Install and connect to a network
to a network
Perform all steps in “Before you begin“ on page 78
“Unpack and install the instrument“ on page 79
“Power on and follow the startup wizard“ on page 80
“Perform instrument verification using RNase P plates“ on page 57
“Connect the instrument and the computer directly or to a LAN“ on page 80
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1
7
66
5
4
2
3
Appendix A Install and connect the instrument to a network
A

Before you begin

Before you begin
This section provides instructions for customer installation of the computer and the instrument. For installation by a eld service engineer (FSE), contact Support to order a service call.
Before starting the installation, complete the following tasks:
• Determine the conguration for your instrument and obtain the network information you need (see “Networking“ on page 81).
• Review site requirements (see QuantStudio™ 1 Real-Time PCR System Site Preparation Guide (Pub. No. MAN0017854).
• Review instrument and computer connections (see “Instrument and computer connections“ on page 78).

Instrument and computer connections

Figure 4 Instrument back panel
1
USB ports
2
WiFi USB port—Connect USB wireless adapter for wireless network access (ordered separately)
3
Ethernet Port—RJ45 port for 100/1,000 Mbps Ethernet communication with the instrument
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4
RS232 Port—For service use only
5
Fuse Cover
6
Power Switch
7
Power Port—100 to 240 VAC
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3
1 1
2
4
Appendix A
Figure 5 Instrumenttocomputer connections (minitower configuration)
1
Detachable power supply cord compatible with local power supply receptacle.
2
Connection between the computer and the instrument.
3
Connection between the computer and the monitor, keyboard, and mouse.
4
Connection between the computer and the
Install and connect the instrument to a network
(optional)

Unpack and install the instrument

handheld barcode scanner.
A
Unpack and install the instrument
Prepare the installation site as described in the QuantStudio™ 1 Real-Time PCR
1.
System Site Preparation Guide (Pub. No. MAN0017854).
Follow the pre-printed instructions on the instrument box to unpack the
2.
instrument, accessories, and reference documentation. Save the packing material for future use or recycle it.
The instrument box contains:
• Reference documentation: Welcome note, unpacking and set up instructions card, system documentation insert
• One instrument
• Accessories: power cable, Ethernet cable, USB drive, reaction tube retainer
• Shipping plate
Note: Save the shipping plate but do not use it to operate the instrument.
If you ordered the wireless adapter, it is provided separately.
Place the instrument on the bench.
3.
Plug the power cable into the power port on the back panel of the instrument,
4.
then plug the cable into an electrical receptacle.
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Appendix A
A

Power on and follow the startup wizard

Install and connect the instrument to a network
Connect your instrument as required by your network conguration (see
5.
“Supported options for instrument and computer connections“ on page 16 and “Instrument and computer connections“ on page 78).
• Connect an Ethernet cable to the Ethernet port on the back panel of the instrument, then connect the cable to a computer or a networking port.
or
• Connect wirelessly via the wireless adapter.
Note: Do not connect the High Power USB WiFi Module (Cat. No. A26774) to the instrument if it is connected to a network by an Ethernet cable. Conguring the instrument for both wired and wireless connection can interfere with instrument operation.
Power on and follow the startup wizard
Power on the instrument.
1.
Follow the startup wizard through the following tasks:
2.
• Select the language for the instrument.
• Accept the license agreement.
• Select a Wired or Wireless networking option, as needed for your
conguration (see “Supported options for instrument and computer connections“ on page 16).
Congure the instrument date and time.
• Create an administrator instrument prole.
Note: You can perform any of the steps above at a later time if you do not have the information needed to complete the startup screens. See Chapter 3, “Congure the instrument and manage instrument proles“.
IMPORTANT! Before using the instrument for the rst time, we recommend that you
perform instrument verication using RNase P plates (see “Perform instrument verication using RNase P plates“ on page 57).

Connect the instrument and the computer directly or to a LAN

This section describes direct wired connection of the computer provided by Thermo Fisher Scientic to the instrument or to a LAN.
Do not connect a customer-provided computer to the instrument.
Connect an Ethernet cable from the instrument or a LAN to the computer.
1.
Power on the computer, then log in using a Windows™ Administrator account.
2.
In the Windows™desktop, right-click My Network Places4Properties.
3.
Right-click Local Area Connection, then select Properties.
4.
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Appendix A Install and connect the instrument to a network
Select Internet Protocol (TCP/IP)4Properties.
5.
Set the Internet Protocol (TCP/IP) Properties for either DHCP or Static IP
6.
communication:

Networking

A
Network
configuration
DHCP
Static IP
If your network requires advanced TCP/IP setup (such as WINS), dene the
7.
seings:
Click Advanced in the Internet Protocol (TCP/IP) Properties dialog box.
a.
Dene the IP Seings, DNS, and WINS tabs as instructed by your systems
b.
administrator, then click OK.
Action
1. Select Obtain an IP address automatically.
2. Set the DNS address. If the computer obtains DNS addresses:
• Automatically – Select Obtain DNS server address automatically.
• Statically – Select Use the following DNS address, then enter the address of the preferred and alternate DNS servers (if available).
1. Select Use the following IP address.
2. In the IP Address field, enter the static IP address.
3. If necessary, enter a subnet mask.
4. If necessary, enter a static gateway address in the Default Gateway field.
Close all dialog boxes by clicking OK, then re-start the computer.
8.
The computer is now visible to other computers on the network.
Networking
IMPORTANT! This section provides general networking information. It does not
provide adequate detail to integrate the instrument into all possible network architectures. Because a network may contain advanced features (such as a rewall or network domains), we recommend that you consult a network administrator before connecting the instrument to your laboratory network.

Supported options for instrument and computer connections

QuantStudio™ 1 Real-Time PCR System Installation, Use, and Maintenance Guide
We support the following direct, networked (LAN– local area network), or Cloud
congurations. Congurations other than those listed are not recommended. Select a conguration that meets the needs of your laboratory's instrument, software, and workow requirements.
IMPORTANT!
(Cat. No. A26774) to the instrument. Conguring the instrument for both wired and wireless connection can interfere with instrument operation.
Do not connect both an Ethernet cable and the Wi-Fi module
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LAN
LAN
LAN
Appendix A Install and connect the instrument to a network
A
Networking
Note: For detailed information about networking your instrument, see the
QuantStudio™ 1 Real-Time PCR System IT Checklist (Pub. No. MAN0018164).
Direct configuration option
• A computer provided by Thermo Fisher Scientific with the QuantStudio™ Design and Analysis Desktop Software
• Computertoinstrument connection: – Direct, wired connection between the computer and the instrument
using an Ethernet cable
IMPORTANT! A direct instrumenttocomputer connection
with the LAN or the Cloud configurations.
Networked configuration option
• A computer provided by Thermo Fisher Scientific with the QuantStudio™ Design and Analysis Desktop Software
• The computer and instrument must be on the same subnet mask.
• ComputertoLAN connection – Wired connection to the network using an Ethernet cable –
– Wireless connection to the network
• InstrumenttoLAN connection – Wired connection to the network using an Ethernet cable –
– Wireless connection to the network using the instrument WiFi module
Thermo Fisher Cloud configuration option
• Internet access and a computer with the Chrome™ web browser to access the Cloud
• ComputertoCloud connection – Wired connection to the internet using an Ethernet cable –
– Wireless connection to the internet
(select an option)
(select an option)
(select an option)
:
cannot
:
:
be combined
or
or
or
• InstrumenttoCloud connection – Wired connection to the network using an Ethernet cable –
– Wireless connection to the network using the instrument WiFi module
Control and monitor networked
When the instrument is connected to a network:
• Computers on the network that are running the desktop software can control the
instruments
(select an option)
:
instrument. Networked instruments can be controlled by only one computer at a time.
• Instruments linked to the Cloud cannot be controlled remotely. However, you can:
– Remotely access the cloud software to create (and analyze) experiments.
– From the instrument, download the experiments and start a run.
– Monitor a run from the Cloud in real time.
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Appendix A Install and connect the instrument to a network
Networking
A

Ethernet port overview

Firewall ports that must be open

The Ethernet port of the instrument supports:
• Static IP network service with subnet mask, primary and secondary data network service (DNS), and default gateway seings, or dynamic host conguration protocol (DHCP) network service.
• mDNS/DNS for local domains.
Note: Because mDNS is limited to direct network connections, an instrument congured for mDNS may not be visible to other nodes that are separated by a router, hub, or another network device.
• IPv4 linknlocal (IPV4LL) in the RFC (also known as Automatic Private IP Addressing [APIPA] or Internet Protocol Automatic Conguration [IPAC]).
Note: When an instrument is set for DHCP, APIPA is automatically enabled, and the instrument provides an IP address when no address is supplied by the DHCP server.
Ports
80/443
mDNS, 7000 Instrument-to-computer connection
mDNS, 5353 Instrument discovery
instrument-to-Cloud and computer-to-Cloud connections
Condition
Standard ports for

Networking guidelines and best practices

• Consult a network administrator before connecting the instrument to a network.
• To enable the full functionality of the software, the computer requires a network connection.
• Open the rewall port for the instruments to be discovered. See “Firewall ports that must be open“ on page 83.
• Observe the restrictions to mDNS and Autodiscovery. The instrument supports mDNS but only when the instrument and computer
share a direct network connection and are within the same subnet. Network computers that are separated from the instrument by a router, hub, or another network device may not be able to access the instrument by its host name.
Conrm the uniqueness of the instrument name.
– The instrument name must be unique within the subnet. The desktop
software can automatically discover instruments on the link-local network.
– The instrument does not test the uniqueness of the instrument name within
the subnet when it is set.
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B
Observation Possible cause Recommended action
Inconsistent communication between instrument and computer or instrument and Cloud
The connection between the instrument and the computer is not recognized
Insufficient disk space message Insufficient disk space to save a
The touchscreen is black The instrument is in sleep
Forgot PIN for instrument
profile
The instrument is configured for
both
wired and wireless
network connection.
Weak or unstable internet connection, especially if configured for wireless.
The connection is not fully established.
If using a networked configuration, the instrument and computer are not on the same subnet mask.
If using a networked configuration, the instrument or computer has an invalid IP address.
run.
mode.
The instrument is not powered on.
Non-administrator forgot instrument profile PIN.
Administrator forgot instrument profile PIN.
Troubleshooting
Ensure only one connectivity option is plugged into the instrument (either an Ethernet cable
or
a wireless adapter, but not both).
Configure for wired or wireless network connection.
Change the configuration to a wired connection.
Use a wireless network with a stronger or more consistent signal.
Power the instrument off, then power it on again.
Contact your information technologies department to have them ensure that the instrument and computer are on the same subnet mask.
Contact your information technologies department to have them ensure that the IP addresses are valid.
1. In the home screen, touch Settings4Run History4Manage.
2. Delete or transfer experiments from the
instrument.
Touch anywhere on the instrument touchscreen.
If you touch the instrument touchscreen and it remains black, check if the instrument is powered on. The power switch is located on the rear panel of the instrument.
If the instrument does not power on, check that the instrument is properly plugged in.
If the instrument does not power on and the instrument is properly plugged in, contact Support.
See “Manage all instrument profiles (Administrator only)“ on page 37.
Have another administrator reset the PIN for the forgotten-PIN profile (see “Manage all instrument profiles (Administrator only)“ on page 37).
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Observation Possible cause Recommended action
Forgot PIN for instrument
profile
High fluorescence signal The reaction volume is not
correct.
Signals that exceed the limit of normal fluorescence may indicate fluorescent contaminants on the plate or the sample block.
Appendix B Troubleshooting
Networking
If there is not another administrator profile on the instrument, you must restore factory defaults (see “Restore factory defaults“ on page 34).
Ensure that reaction volumes in the plate are correct and match the volume that is entered in the Method tab.
Examine the bottom of the reaction plate. If there is contamination, prepare a new plate and run the experiment again.
Identify the location of contamination on the plate or sample block.
1. Obtain or prepare a background plate (see page 56).
2. Follow the procedures that are described in “Identify contamination“ on page 56.
B
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C
Instrument specification and layout
Congured system dimensions ......................................... 87
Electrical requirements ................................................ 88
Environmental requirements ........................................... 89
Network requirements ................................................ 90
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Configured system dimensions
27 cm (10.5 in.)
50 cm (20 in.)
15 cm (6 in.)
40 cm (16 in.)
30 cm (12 in.)
207 cm (81.5 in.)
Allow space for the congured instrument. A typical setup with a co-located minitower computer is shown below.
Note: Dimensions are rounded to the nearest whole or half unit.
Appendix C Instrument specification and layout
Configured system dimensions
C
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Appendix C Instrument specification and layout
C

Electrical requirements

Instrument clearances

During instrument installation and maintenance, it is necessary to access the back of the instrument. If the back of the instrument faces a wall, ensure that there is sucient clearance on the bench to rotate the instrument for access.
IMPORTANT! For safety, the power outlet for the instrument must be accessible.
Component Top Front Sides Back
Instrument 30 cm (12 in.) 30 cm (12 in.) 15 cm (6 in.) 15 cm (6 in.)
Computer
[1]
Co-locating the computer with the instrument is optional.
[1]
Electrical requirements
WARNING! For safety, the power outlet used for powering the instrument
must be accessible at all times. See “Instrument clearances“ on page 88 for information about the space needed between the wall and the instrument. In case of emergency, you must be able to immediately disconnect the main power supply to all the equipment. Allow adequate space between the wall and the equipment so that the power cords can be disconnected in case of emergency.
15 cm (6 in.) 15 cm (6 in.)
• Electric receptacle with grounding capability
• Maximum power dissipation: ~960 W (not including computer and monitor)
• Mains AC line voltage tolerances must be up to ±10 percent of nominal voltage
[1]
Circuit
required
10 A 50/60 Hz 750 W
Device
Instrument 100–240 ±10% VAC
Computer (laptop) 100–240 ±10% VAC 10 A 50/60 Hz 90 VA
Computer (desktop)
Monitor 65 VA
[1]
If the supplied power fluctuates beyond the rated voltage, a power line regulator may be required. High or low voltages can adversely affect the electronic components of the instrument.
Rated voltage
100–240 ±10% VAC 10 A 50/60 Hz
Rated
frequency
Rated
power
125 VA
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Environmental requirements

Table 3 Environmental requirements
Condition Acceptable range
Installation site Indoor use only
Appendix C Instrument specification and layout
Environmental requirements
C
Electromagnetic interference
Altitude Between sea level and 2000 m (6500 ft.) above sea level
Operating conditions
Storage and transport conditions
Thermal output During operation, the net thermal output, based on the actual
Vibration Ensure that the instrument is not adjacent to strong vibration
Pollution degree The instrument has a Pollution Degree rating of II. The
Do not use this device in close proximity to sources of strong electromagnetic radiation (for example, unshielded intentional RF sources). Strong electromagnetic radiation may interfere with the proper operation of the device.
• Humidity: 15–80% relative humidity (noncondensing)
• Temperature: 15 to 30°C (59 to 86°F)
Note: For optimal performance, avoid rapid or extreme fluctuations in room temperature.
• Humidity: 20–80% relative humidity (noncondensing)
• Temperature: –30 to 60°C (–22 to 140°F)
current draw of the instrument, is expected to be approximately 960 W (3275 Btu/h).
sources, such as a centrifuge, pump, or compressor. Excessive vibration will affect instrument performance.
instrument may only be installed in an environment that has nonconductive pollutants such as dust particles or wood chips. Typical environments with a Pollution Degree II rating are laboratories and sales and commercial areas.
The noise output of the instrument is £ 60 dB when running.
Other conditions Ensure the instrument is located away from any vents that
could expel particulate material onto the instrument components.
Avoid placing the instrument and computer adjacent to heaters, cooling ducts, or in direct sunlight.
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Appendix C Instrument specification and layout
C

Network requirements

Network requirements
The instrument:
• Is factory-congured for IPv4 TCP/IP communication and includes an Ethernet adapter (100/1,000 Mbps) with an RJ45-type connector for integrating the device into a local area network (LAN).
• Can alternatively be congured for wireless networking (High Power USB WiFi Module required, sold separately as an optional accessory).
The instrument can be congured for either wired or wireless networking, not both.
If a Thermo Fisher Scientic service representative is to install the instrument:
• If the instrument will be connected to a LAN, an active, tested network jack must be in place before the scheduled installation date.
• A representative from your information technologies department must be available during the installation to help connect the instrument to your network.
Required materials to network the instrument:
• Wired—Ethernet cable of sucient length with RJ45 connectors
– CAT5 cable for a 100 Mbps network connection
– CAT5e or CAT6 cable for a 1,000 Mbps network connection
or
• Wireless—High Power USB WiFi Module (Cat. No. A26774, sold separately)
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Parts and materials
D
Kits, consumables, accessories, and reagents ............................. 91
Consumables (96-well, 0.2-mL format) .................................. 91
Accessories ......................................................... 92
General-use materials and consumables ................................. 92

Kits, consumables, accessories, and reagents

Unless otherwise indicated, all materials are available through thermosher.com.
Store all calibration and RNase P plates at –20°C. All other items can be stored at 15–30°C. Use all materials by the expiration date on the packaging.

Consumables (96well, 0.2mL format)

Consumable
MicroAmp™ Optical 8-Cap Strips 300 strips 4323032
MicroAmp™ Optical 8-Tube Strip, 0.2 mL 125 strips 4316567
MicroAmp™ Optical Tube without Cap, 0.2 mL 2,000 tubes N8010933
MicroAmp™ Optical 96-Well Reaction Plate with Barcode
MicroAmp™ EnduraPlate™ Optical 96-Well Clear GPLE Reaction Plates with Barcode
Instrument verification or calibration plate Cat. No.
TaqMan® RNase P Instrument Verification Plate, 96Well 0.2mL 4432382
Region of Interest (ROI) and Background Plates, 96Well 0.2mL (2 plates) 4432364
QuantStudio™ 3/5 Spectral Calibration Plate 1 (FAM™, VIC™, ROX™, and SYBR™ dyes), 96Well 0.2mL
QuantStudio™ 3/5 Spectral Calibration Plate 2, 96Well 0.2mL (ABY™, JUN™, and MUSTANG PURPLE™ dyes)
[1]
Compatible with QuantStudio™ 1 Real-Time PCR System.
[1]
Amount Cat. No.
20 plates 4306737
500 plates 4326659
20 plates 4483348
500 plates 4483351
A26331
[1]
A26332
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Appendix D Parts and materials
D

Accessories

Accessories
Item
MicroAmp™ 96-Well Tray/Retainer Set 10 trays 4381850
MicroAmp™ Multi Removal Tool 1 tool 4313950
MicroAmp™ Cap Installing Tool (handle style) 1 tool 4330015
MicroAmp™ Optical Adhesive Film 25 films 4360954
MicroAmp™ Adhesive Film Applicator 5 applicators 4333183
RT-PCR Grade Water 10 × 1.5 mL tubes AM9935
Handheld Barcode Scanner 1 scanner 4488442
High Power USB WiFi Module 1 module A26774

General-use materials and consumables

The following general-use materials and consumables are required to calibrate, maintain, and operate the instrument. Unless otherwise indicated, all materials are available through thermosher.com. MLS: Fisher Scientic (sherscientic.com) or other major laboratory supplier.
Amount Cat. No.
100 films 4311971
Material/Consumable
Bleach, 10% solution MLS
Centrifuge with 96well plate buckets MLS
Cotton or nylon swabs and lintfree cloths MLS
Ethanol, 95% solution MLS
Optical clear adhesive film for PCR MLS
Pipettors, 100µL and 200µL (with pipette tips) MLS
Powderfree gloves MLS
Safety glasses MLS
Screwdriver, flathead MLS
Tissue, lintfree MLS
Deionized water MLS
Source
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E
Safety
Symbols on this instrument ............................................ 94
Safety alerts on this instrument ......................................... 96
Safety information for instruments not manufactured by Thermo
Fisher Scientic ...................................................... 97
Instrument safety ..................................................... 97
Safety and electromagnetic compatibility (EMC) standards ................ 98
Chemical safety ..................................................... 100
Biological hazard safety .............................................. 101
WARNING! GENERAL SAFETY. Using this product in a manner not specied
in the user documentation may result in personal injury or damage to the instrument or device. Ensure that anyone using this product has received instructions in general safety practices for laboratories and the safety information provided in this document.
Before using an instrument or device, read and understand the safety
·
information provided in the user documentation provided by the manufacturer of the instrument or device. Before handling chemicals, read and understand all applicable Safety Data
·
Sheets (SDSs) and use appropriate personal protective equipment (gloves, gowns, eye protection, and so on). To obtain SDSs, see the “Documentation and Support” section in this document.
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Appendix E Safety
E

Symbols on this instrument

Symbols on this instrument
Symbols may be found on the instrument to warn against potential hazards or convey important safety information. In this document, the hazard symbol is used along with one of the following user aention words:
CAUTION! – Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices.
WARNING! – Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.
DANGER! – Indicates an imminently hazardous situation that, if not avoided, will result in death or serious injury.
Symbol
English Français
Caution, risk of danger
Consult the manual for further safety information.
Moving parts Parties mobiles
Caution, hot surface Attention, surface chaude
On On (marche)
Off Off (arrêt)
Protective conductor terminal (main ground)
Attention, risque de danger
Consulter le manuel pour d’autres renseignements de sécurité.
Borne de conducteur de protection (mise à la terre principale)
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Symbol English Français
Appendix E Safety
Symbols on this instrument
E

Conformity symbols

Do not dispose of this product in unsorted municipal waste
Conformity mark
Ne pas éliminer ce produit avec les déchets usuels non soumis au tri sélectif.
CAUTION! To minimize
negative environmental impact from disposal of electronic waste, do not dispose of electronic waste in unsorted municipal waste. Follow local municipal waste ordinances for proper disposal provision and contact customer service for information about responsible disposal options.
Description
Indicates conformity with safety requirements for Canada and U.S.A.
MISE EN GARDE ! Pour
minimiser les conséquences négatives sur l’environnement à la suite de l’élimination de déchets électroniques, ne pas éliminer ce déchet électronique avec les déchets usuels non soumis au tri sélectif. Se conformer aux ordonnances locales sur les déchets municipaux pour les dispositions d’élimination et communiquer avec le service à la clientèle pour des renseignements sur les options d’élimination responsable.
Indicates conformity with European Union requirements for safety and electromagnetic compatibility.
Indicates conformity with Australian standards for electromagnetic compatibility.
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Appendix E Safety
E

Safety alerts on this instrument

Safety alerts on this instrument
Additional text may be used with one of the symbols described above when more specic information is needed to avoid exposure to a hazard. See the following table for safety alerts found on the instrument.
English Français
CAUTION! Hazardous chemicals.
Read the Safety Data Sheets (SDSs) before handling.
CAUTION! Hazardous waste. Refer
to SDS(s) and local regulations for handling and disposal.
MISE EN GARDE ! Produits
chimiques dangereux. Lire les
fiches signalétiques (FS) avant de manipuler les produits.
MISE EN GARDE ! Déchets
dangereux. Lire les fiches
signalétiques (FS) et la réglementation locale associées à la manipulation et à l’élimination des déchets.
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1
2
1
2

Location of safety labels on the instrument

Safety information for instruments not manufactured by Thermo Fisher Scientific
Appendix E Safety
E
1
Moving parts
2
Physical injury hazard
Safety information for instruments not manufactured by Thermo Fisher Scientific
Some of the accessories provided as part of the instrument system are not designed or built by Thermo Fisher Scientic. Consult the manufacturer's documentation for the information needed for the safe use of these products.

Instrument safety

General

QuantStudio™ 1 Real-Time PCR System Installation, Use, and Maintenance Guide
CAUTION!
protective instrument panels or disable interlock devices, you may be exposed to serious hazards including, but not limited to, severe electrical shock, laser exposure, crushing, or chemical exposure.
Do not remove instrument protective covers. If you remove the
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Appendix E Safety
E

Safety and electromagnetic compatibility (EMC) standards

Physical injury

Electrical safety

CAUTION! Moving Parts. Moving parts can crush, pinch and cut. Keep hands
clear of moving parts while operating the instrument. Disconnect power before servicing.
WARNING! Do not aempt to lift or move the instrument without the
assistance of others. Use appropriate moving equipment and proper lifting technique, improper lifting may result in serious injury.
WARNING! Ensure appropriate electrical supply. For safe operation of the
instrument:
Plug the system into a properly grounded receptacle with adequate current
·
capacity. Ensure the electrical supply is of suitable voltage.
·
Never operate the instrument with the ground disconnected. Grounding
·
continuity is required for safe operation of the instrument.
WARNING! Power Supply Line Cords. Use properly congured and approved
line cords for the power supply in your facility.
WARNING! Disconnecting Power. To fully disconnect power either detach or
unplug the power cord, positioning the instrument such that the power cord is accessible.

Cleaning and decontamination

CAUTION! Cleaning and Decontamination. Use only the cleaning and
decontamination methods specied in the manufacturer's user documentation. It is the responsibility of the operator (or other responsible person) to ensure the following requirements are met:
No decontamination or cleaning agents are used that could cause a
·
HAZARD as a result of a reaction with parts of the equipment or with material contained in the equipment. The instrument is properly decontaminated a) if hazardous material is
·
spilled onto or into the equipment, and/or b) prior to having the instrument serviced at your facility or sending the instrument for repair, maintenance, trade-in, disposal, or termination of a loan (decontamination forms may be requested from customer service). Before using any cleaning or decontamination methods (except those
·
recommended by the manufacturer), users should conrm with the manufacturer that the proposed method will not damage the equipment.
Safety and electromagnetic compatibility (EMC) standards
The instrument design and manufacture complies with the standards and requirements for safety and electromagnetic compatibility as noted in the following table:
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Safety and electromagnetic compatibility (EMC) standards
Appendix E Safety
E

Safety compliance

EMC
Reference
EU Directive 2014/35/EU
IEC 61010-1
EN 61010-1
UL 61010-1
CSA C22.2 No. 61010-1
IEC 61010-2-010
EN 61010-2-010
IEC 61010-2-081
EN 61010-2-081
European Union “Low Voltage Directive”
Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-010: Particular requirements for laboratory equipment for the heating of materials
Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for
Description
analysis and other purposes
Reference
Directive 2014/30/EU European Union “EMC Directive”
Description
EN 61326-1/ IEC 61326-1
Electrical Equipment for Measurement, Control and Laboratory Use – EMC Requirements – Part 1: General Requirements
AS/NZS CISPR 11
Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment
ICES-001, Issue 4
Industrial, Scientific and Medical (ISM) Radio Frequency Generators
FCC Part 15 Subpart B (47 CFR)
U.S. Standard Radio Frequency Devices
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.
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Appendix E Safety
E

Chemical safety

Environmental design

Chemical safety
Reference
Directive 2012/19/EU European Union “WEEE Directive” – Waste electrical and
electronic equipment
Directive 2011/65/EU European Union “RoHS Directive” – Restriction of hazardous
substances in electrical and electronic equipment
Directive 2006/66/EC European Union “Battery Directive”
WARNING! GENERAL CHEMICAL HANDLING. To minimize hazards,
ensure laboratory personnel read and practice the general safety guidelines for chemical usage, storage, and waste provided below. Consult the relevant SDS for specic precautions and instructions:
Read and understand the Safety Data Sheets (SDSs) provided by the
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chemical manufacturer before you store, handle, or work with any chemicals or hazardous materials. To obtain SDSs, see the “Documentation and Support” section in this document. Minimize contact with chemicals. Wear appropriate personal protective
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equipment when handling chemicals (for example, safety glasses, gloves, or protective clothing). Minimize the inhalation of chemicals. Do not leave chemical containers open.
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Use only with adequate ventilation (for example, fume hood). Check regularly for chemical leaks or spills. If a leak or spill occurs, follow
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the manufacturer's cleanup procedures as recommended in the SDS. Handle chemical wastes in a fume hood.
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Ensure use of primary and secondary waste containers. (A primary waste
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container holds the immediate waste. A secondary container contains spills or leaks from the primary container. Both containers must be compatible with the waste material and meet federal, state, and local requirements for container storage.) After emptying a waste container, seal it with the cap provided.
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Characterize (by analysis if necessary) the waste generated by the particular
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applications, reagents, and substrates used in your laboratory. Ensure that the waste is stored, transferred, transported, and disposed of
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according to all local, state/provincial, and/or national regulations.
IMPORTANT! Radioactive or biohazardous materials may require special
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handling, and disposal limitations may apply.
Description
100
QuantStudio™ 1 Real-Time PCR System Installation, Use, and Maintenance Guide
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