ThermoFisher Scientific QuantStudio 6 Pro User Manual Download

Page: 129 / 216

(continued)

Component

Functionality with an SAE-enabled plate or

data file

Functionality with an SAE-disabled plate or

data file

QuantStudio

™

7 Pro

Real-Time PCR
System with SAE
disabled

• The plate file can be opened and edited.
• The file can be saved as an invalid SAE

file only.

[1]

• The file can be used to start an run, but

the data file will be an invalid SAE file.

[1]

The file can be opened, edited, and saved.

[1]

Invalid SAE files contain incomplete audit records.

[2]

You cannot import plate files from the Connect cloud-based platform when the instrument has SAE enabled.

Enable SAE functions

Workflow: Enable SAE functions

Configure SAE Administrator Console application profiles

(page 129)

▼

Enable SAE on the instrument and specify the SAE server

(administrator only) (page 130)

▼

Connect to the SAE server (page 131)

▼

Enable SAE functions in QuantStudio

™

Design and Analysis

Software v2 (page 131)

Configure SAE Administrator Console application profiles

Note:

Configuring application profiles in the SAE Administrator Console requires an

SAE administrator account.

In the SAE Administrator Console, an application profile contains default settings for
an application. Before using the Security, Auditing, and E

‑

signature (SAE) v2.0

module, an administrator must install, then configure profiles for the following
applications:

1. QuantStudio

™

7 Pro Real-Time PCR System

2. QuantStudio

™

Design and Analysis Software v2

Note:

The QuantStudio

™

7 Pro Real-Time PCR System profile must be installed

before the QuantStudio

™

Design and Analysis Software v2 profile.

For information on configuring application profiles, see

SAE Administrator Console

v2.0 User Guide

(Pub. No. MAN0017468).

Chapter 9

Use the instrument with the Security, Auditing, and E

‑

signature (SAE) v2.0 module

Enable SAE functions

QuantStudio

™

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

129

Summary of Contents for QuantStudio 6 Pro

Page 1: ...For Research Use Only Not for use in diagnostic procedures QuantStudio 6 Pro and 7 Pro Real Time PCR Systems USER GUIDE Publication Number MAN0018045 Revision E 0...

Page 2: ...the amplification plot after a run Added instructions to view QC Check status after the run Added information about a locked template file Added functions for using the instrument with the SAE Admini...

Page 3: ...region for the Connect cloud based platform A run cannot be started if a block has never been calibrated on the instrument The options after a calibration run is complete The example files for the des...

Page 4: ...ator 21 Hands free features 21 Facial authentication 21 Voice activation 21 Indicators for the hands free features 22 Software description 23 Parts of the home screen 23 Connect and Cloud definitions...

Page 5: ...run a plate 46 Create and run a plate from a system template or a saved plate file 46 Repeat the last run 48 Overview of customized data export 49 Optional Scan a barcode using a barcode scanner 50 L...

Page 6: ...run 68 View real time data and plots during a run 68 Adjust the display of real time plots during a run 69 View the time remaining during a run 69 Lock the touchscreen during a run 69 Unlock the touch...

Page 7: ...0 Perform verification using RNase P plates 91 Instrument verification description 91 RNase P instrument verification plate 92 Performance specifications pass criteria 93 Prepare an RNase P plate 93 P...

Page 8: ...enabled 123 Security Auditing and E signature SAE v2 0 module functions 124 Functions that are controlled 124 Functions that can be audited 125 Functions that can be signed 125 Security Auditing and E...

Page 9: ...are the instrument to store move or ship 152 Move the instrument 152 CHAPTER 11 Configure the instrument settings 153 View the instrument details 153 View the license agreement 154 View the privacy po...

Page 10: ...nt for the hands free features 166 Manage the run history 166 Manage the file name convention of the data file 167 View the notifications 167 Enable and disable home screen notifications 168 Set up em...

Page 11: ...cessories 186 APPENDIX D Safety 187 Symbols on this instrument 187 Standard safety symbols 188 Additional safety symbols 189 Location of safety labels 189 Control and connection symbols 193 Conformity...

Page 12: ...IX E Documentation and support 206 Related documentation 206 Customer and technical support 207 Limited product warranty 207 Index 208 Contents 12 QuantStudio 6 Pro and 7 Pro Real Time PCR Systems Use...

Page 13: ...r network drives are connected to the software it is the responsibility of your IT personnel to ensure that such drives are configured and secured correctly to prevent data corruption or loss It is th...

Page 14: ...instrument is available with an interchangeable block The following blocks are available 96 well 0 2 mL block 96 well 0 1 mL block 384 well block The instrument can be used directly from the touchscre...

Page 15: ...module Instrument filters and supported dyes System dyes The QuantStudio 6 Pro Real Time PCR System has a coupled five color filter set The QuantStudio 7 Pro Real Time PCR System has a decoupled six...

Page 16: ...s Red dye 5 x5 m5 Cy 5 MUSTANG PURPLE dye Custom dyes The instrument can run assays designed with custom dyes Custom dyes include the following options Dyes that are not supplied by Thermo Fisher Scie...

Page 17: ...ed Optional During the thermal cycling protocol Collecting data during the run can confirm genotyping results by viewing traces in allelic discrimination plots or viewing genotyping calls at earlier c...

Page 18: ...ility of plate files on page 28 AutoDelta settings AutoDelta enables an incremental increase or decrease in the temperature or time in a PCR cycle To use AutoDelta specify a difference in the time and...

Page 19: ...ment 1 Cameras 2 Touchscreen 3 Microphones 4 USB port 5 Indicator light 6 Proximity sensor 7 Access door for block change 8 Speakers 9 Drawer Chapter 1 Product information Instrument hardware descript...

Page 20: ...inlet receptacle Note The instrument recognizes only one external storage device at a time for data transfer The USB ports at the rear of the instrument can be used for external devices for example a...

Page 21: ...ent allows hands free facial authentication to sign in a user The instrument camera detects a face The instrument will sign in the user after the face is matched to the photo associated with a profile...

Page 22: ...abled by an administrator The user is signed in with a local profile The voice command function has been disabled by the user and the proximity sensor does not detect a person The icon will return to...

Page 23: ...e 115 Software description Parts of the home screen 1 2 3 4 5 6 7 8 9 10 11 Figure 5 Home screen 1 Instrument name 2 Instrument calendar 3 Microphone 4 Help 5 Eject 6 Status dial 7 Block installed 8 C...

Page 24: ...plicable the following items are noted If there is no block and heated cover set installed If the block and heated cover are mismatched Current user Displays the current signed in user Guest is displa...

Page 25: ...is document The following icons are used interchangeably on the instrument touchscreen The icon is used in this document Instrument desktop software and Connect platform features The instrument and th...

Page 26: ...locations and files File locations File location Description and function Run queue Plate files sent from the desktop software Public Plate files saved by guest users are stored in this folder Data f...

Page 27: ...in a back up of the instrument and are not restored when a backup of the instrument is restored Plate files and data files must be transferred separately See Chapter 6 View and manage files System tem...

Page 28: ...tains the target information The target information can be edited on the desktop software or on the Connect platform after the run is complete Sample information and target information can be edited o...

Page 29: ...o Delta settings Thermal cycling conditions Plate Sample names Targets SNP assays Define and assign samples targets or SNP assays and tasks in the Plate setup screen Run Monitor a run in progress View...

Page 30: ...rk Direct connection Local area network LAN connection Connect platform connection wired wired or wireless wired or wireless Types of runs Standard curve run A standard curve run determines the absolu...

Page 31: ...ndogenous 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...

Page 32: ...genotype call to the samples of each cluster according to its position on the plot Presence absence run Presence absence run determines the presence or absence of a target nucleic acid sequence in a...

Page 33: ...t curve run no PCR stage 96 well 0 2 mL Standard plate Fast cycling mode QS7Pro 96 Well 0 2ml_Melt_Std edt Melt curve run no PCR stage 96 well 0 2 mL Standard plate Standard cycling mode QS7Pro 96 Wel...

Page 34: ...ast edt Standard curve run 96 well 0 2 mL Standard plate Fast cycling mode QS7Pro 96 Well 0 2ml_SC_Std edt Standard curve run 96 well 0 2 mL Standard plate Standard cycling mode System template file n...

Page 35: ...e Standard cycling mode QS7Pro 96 Well 0 1ml_RQ_Fast edt Comparative Ct run 96 well 0 1 mL Standard plate Fast cycling mode QS7Pro 96 Well 0 1ml_RQ_Std edt Comparative Ct run 96 well 0 1 mL Standard p...

Page 36: ...PA Fast edt Presence absence run 384 well plate Fast cycling mode QS7Pro 384 Well PA Std edt Presence absence run 384 well plate Standard cycling mode QS7Pro 384 Well PCR Melt Fast edt Melt curve run...

Page 37: ...edt Relative standard curve run 384 well plate Standard cycling mode QS7Pro 384 Well SC Fast edt Standard curve run 384 well plate Fast cycling mode QS7Pro 384 Well SC Std edt Standard curve run 384 w...

Page 38: ...te into the instrument Start the run Unload the plate from the instrument Optional Transfer the data file A location to transfer the data file might have been selected before the run The data file onl...

Page 39: ...inued protection against the risk of fire replace fuses only with listed and certified fuses of the same type and rating as those currently in the instrument CAUTION PHYSICAL INJURY HAZARD During inst...

Page 40: ...strument see Recommended order to set up profiles on page 108 Overview of guest access The instrument can be used without signing in The following limits are in place if you do not sign in to the inst...

Page 41: ...In screen guest access has been disabled An administrator must enable guest access see Require sign in on page 107 1 1 Guest button In the Sign In screen tap Guest Chapter 2 Get started Overview of gu...

Page 42: ...e screen becomes active the instrument is already powered on 2 If the home screen does not display power on the instrument by pressing the ON OFF switch on the rear panel 1 Figure 6 Location of the ON...

Page 43: ...rofile must be set up with facial authentication see Add facial authentication to an existing instrument profile on page 118 The instrument must accept facial authentication see Configure the instrume...

Page 44: ...ds free features on page 166 A Connect profile must be used For information about linking a local instrument profile to a Connect profile see Link a local profile to a Connect profile on page 113 Voic...

Page 45: ...block in the instrument the Install Block screen is displayed Instrument scheduler 1 The instrument schedule is displayed Help The help topic associated with the current page on the screen is displaye...

Page 46: ...saved as a new custom plate file Plate files can be edited in Connect or the desktop software The Run Queue folder contains plate files sent to the instrument from the desktop software 1 In the home s...

Page 47: ...was selected to save the data file is interrupted the instrument completes the run The data file is saved on the instrument The data file must be transferred to another location manually see Transfer...

Page 48: ...e To edit the default file name see Manage the file name convention of the data file on page 167 3 Optional Use the barcode scanner See Optional Scan a barcode using a barcode scanner on page 50 4 Tap...

Page 49: ...The status dial is displayed The status dial contains the following information The block temperature The elapsed time of the run The status of the run See Figure 7 on page 48 For options during a ru...

Page 50: ...alphanumeric equivalent of the barcode to the Barcode field Transmits other reagent information For more information about the hand held barcode scanner see the user documentation provided with the ba...

Page 51: ...gn out feature is enabled and the set time has elapsed the instrument will display the Sign In screen 1 Tap Eject to open the instrument drawer then remove the plate 2 Tap Eject to close the instrumen...

Page 52: ...et up with restricted editing only certain parts of the template file can be edited The parts of the template file that cannot be edited are defined by the user in QuantStudio Design and Analysis Soft...

Page 53: ...ns then tap Import sample setup 2 In the Import Sample Setup screen tap the appropriate folder then tap the appropriate file Import an auto export setting The export settings can be customized For mor...

Page 54: ...ge 46 The plate file associated with the last run see Repeat the last run on page 48 The following items can be edited in the Methods tab Time and temperature for each PCR step see page 55 Cover tempe...

Page 55: ...tab tap Edit 2 Tap a field then enter the changes Cover temperature Volume Temperature for any steps Time for any steps Number of PCR cycles 3 Tap Save 4 Enter a name for the plate file then tap Done...

Page 56: ...nage stages Note Use or to navigate through the method if it is not all displayed 2 Tap Add Stage then tap Add in the location of the stage to be added 3 Tap the type of stage Hold Pre Read Post Read...

Page 57: ...es Note For more information about compatibility of plate files with VeriFlex Zones between the two instruments see VeriFlex Zones on page 17 1 In the Method tab tap Edit4Advanced4 VeriFlex Zones Auto...

Page 58: ...y available in the PCR stage 1 In the Method tab tap Edit4Advanced4VeriFlex Zones Auto Delta Note Use or to navigate through the method if it is not all displayed 2 Tap Edit in one of the PCR stages 3...

Page 59: ...tes Note Use or to navigate through the method if it is not all displayed 2 Tap a ramp rate then edit the value 3 Tap Done Add or remove a pause A pause allows you to open the drawer to add additional...

Page 60: ...or preplated assays will already be populated with the target name reporter dye and quencher dye Options to view a plate layout The following views are available for a plate layout Plate view Shows ea...

Page 61: ...a 384 well plate if the 384 well block is installed The plate can be edited in the 384 well view You can zoom in to a 96 well section of the 384 well plate in order to edit the plate Chapter 4 Edit a...

Page 62: ...f assigning or editing a well manually see Import a sample setup on page 53 1 In the Plate tab tap a well or multiple wells 2 Tap the Sample Information pane then tap Samples Note If no wells are sele...

Page 63: ...t the reagent details on page 63 1 In the Plate tab tap one of the following items A single well Multiple wells Select all 2 Tap the Sample Information pane then tap Reagents Note If no wells are sele...

Page 64: ...rence dye is displayed under the plate diagram Import an Assay Information File AIF The Assay Information File is provided in TXT format and or XML and HTML format depending on the product line and or...

Page 65: ...chscreen during a run 70 Instrument Schedule 70 Screens available during a run From the home screen you can swipe or tap the arrows to navigate to different screens The following screens are available...

Page 66: ...e Use the plate view to edit or assign a well see Options to view a plate layout on page 60 4 Tap the Sample Information pane then tap Samples Note If no wells are selected the pane is labeled Legend...

Page 67: ...run pause enter room temperature as the pause temperature and allow the plate to cool to room temperature before handling Stop an instrument run CAUTION PHYSICAL INJURY HAZARD During instrument opera...

Page 68: ...t stage 3 End time 4 Time remaining 2 Swipe right once or tap the left arrow once to return to the home screen View real time data and plots during a run 1 In the home screen during a run swipe left t...

Page 69: ...left three times or tap the right arrow three times The time remaining in the run is displayed 2 Swipe right three times or tap the left arrow three times to return to the home screen Lock the touchs...

Page 70: ...trument at a particular date and time A Connect profile is required The instrument is not locked to prevent any other users at the time Schedule a run 1 In the home screen tap Calendar 2 Select a view...

Page 71: ...endar 2 Select a view Day Week Month 3 Tap the reservation The Edit Reservation screen is displayed 4 Tap Cancel Reservation then tap Yes Chapter 5 Options for a run Instrument Schedule 5 QuantStudio...

Page 72: ...Set up run 2 Tap the appropriate folder Run Queue Public Connect Network Drive USB 3 Tap Manage 4 Tap the file then tap Copy files Multiple files can be selected 5 Select the destination folder Publi...

Page 73: ...Multiple files can be selected 5 Tap Yes to confirm Tap Back to return to the home screen Manage data files View QC Check status after a run The status dial displays Run complete when a run is comple...

Page 74: ...equired for QC Check 1 QC Check 2 See the QC data in the QuantStudio Design and Analysis Software v2 or the QuantStudio Design and Analysis v2 Chapter 6 View and manage files Manage data files 6 74 Qu...

Page 75: ...is displayed The display can be adjusted see Adjust the display of real time plots during a run on page 69 2 Optional On the Details screen tap the Plot Types dropdown list then select a plot type Rn...

Page 76: ...sfer data files at a later time on page 76 Data files will be transferred to the location that was selected before the run was started even if the user was automatically signed out 1 In the home scree...

Page 77: ...ata files Administrators can view all data files 1 In the home screen tap Settings 4Run history The Run History screen is displayed 2 Tap an individual run record then tap View The following details a...

Page 78: ...can view all of the runs performed 2 Optional Tap the table header to sort by that parameter Run name Date Transferred User Administrator only 3 Tap the data files to be deleted or tap Select all Mult...

Page 79: ...The calibration status applies to the combination of the instrument and the block If a block is moved to an instrument that it has not been calibrated on that combination of block and instrument needs...

Page 80: ...calibration after the ROI Uniformity calibration is complete The ROI Uniformity calibration and the Background calibration must pass in order to accept the results It is recommended to transfer the f...

Page 81: ...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 The plate images for all filters a...

Page 82: ...2 Tap a calibration row then tap Edit 3 Tap on the Expiration Interval field then enter the number of days The default is 730 days 2 years 4 Tap on the Reminder field then enter the number of days Th...

Page 83: ...calibration status report 5 In the Calibrations History tab View the history of each calibration type Optional Tap to download the calibration history report Export a calibration report The calibratio...

Page 84: ...s Note We recommend calibrating with all Spectral Dye Calibrations Plates available for your block configuration even if you are not using all the dyes in the plates This is recommended for optimal sy...

Page 85: ...calibration plate Each calibration plate can be used up to three time if the following conditions are met The plate is stored in its packing sleeve at 25 C to 15 C The plate is used within 6 months af...

Page 86: ...he ROI Uniformity run is complete you will be prompted to perform a background calibration When the Background calibration is complete the Calibration Status will display It will indicate whether the...

Page 87: ...libration plate Each calibration plate can be used up to three time if the following conditions are met The plate is stored in its packing sleeve at 25 C to 15 C The plate is used within 6 months afte...

Page 88: ...centers 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 p...

Page 89: ...ap View 4 Tap Transfer EDS Troubleshoot calibration failure Observation Possible cause Recommended action Calibration failed The plate was improperly prepared Ensure the following The correct plate wa...

Page 90: ...led wells again as in step 1 Position of failed wells Action Identical The sample block is contaminated Decontaminate the sample block see page 146 Reversed The plate is contaminated Discard the plate...

Page 91: ...ROI uniformity background and dye calibrations to perform verification Instrument verification description Purpose Description Pass criteria Confirms the performance of the instrument Quantifies the n...

Page 92: ...PCR Master Mix RNase P primers A FAM dye labeled probe A known concentration of human genomic DNA template 1 4 2 5 7 6 3 8 Figure 12 96 well RNase P plate 1 Unknown A 5 000 2 NTC no template control...

Page 93: ...CqA Average Cq of unknown population A CqA Standard deviation of unknown population A CqB Average Cq of unknown population B CqB Standard deviation of unknown population B The software automatically...

Page 94: ...at 750 1 000 g for 2 minutes 5 Confirm that the liquid in each well is at the bottom of the well and free of bubbles If it is not centrifuge the plate again IMPORTANT Keep the bottom of the plate clea...

Page 95: ...from the instrument CAUTION PHYSICAL INJURY HAZARD During instrument operation the plate temperature can reach 100 C Allow it to cool to room temperature before handling Note Use Smart Help if the in...

Page 96: ...on volume is not correct Ensure that reaction volumes in the plate are correct and match the volume that is entered in the Method tab Signals that exceed the limit of normal fluorescence can indicate...

Page 97: ...le for verification in the desktop software or the Connect platform to view the flags and troubleshooting details for failed wells If the verification fails again order a replacement plate Use Smart H...

Page 98: ...mal concentration Create a custom dye calibration plate page 101 Add a custom dye to the instrument page 102 Perform a custom dye calibration page 102 Use a dilution series to determine an optimal cus...

Page 99: ...tion into the center of a reaction plate then seal the plate A full plate is not needed 100 nM 200 nM 400 nM 800 nM 1600 nM 100 nM 200 nM 400 nM 800 nM 1600 nM 100 nM 200 nM 400 nM 800 nM 1600 nM 3 Vo...

Page 100: ...ells 5 Tap Start run 6 When the run is complete transfer the data files for analysis see Transfer a data file immediately after a run on page 76 or Transfer data files at a later time on page 76 7 Unl...

Page 101: ...ncentration that falls within the acceptable signal range Calibrate the custom dye Create a custom dye calibration plate IMPORTANT Wear powder free gloves while creating the dye plate Create a full pl...

Page 102: ...crease 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 dye or a quencher dye 5 Tap Save IMPORTAN...

Page 103: ...that are aligned with the dye wavelength Peak filter Filter wavelength nm 1 Excitation Emission x1 m1 470 15 520 15 x2 m2 520 10 558 11 x3 m3 550 11 586 10 x4 m4 580 10 623 14 x5 m5 640 10 682 14 x6...

Page 104: ...g instrument operation the plate temperature can reach 100 C Allow it to cool to room temperature before handling Note Use Smart Help if the instrument does not eject the plate see Request technical s...

Page 105: ...your reagent kit documentation then the incorrect wavelength may be collected during a run 4 Optional Tap Reagents then enter the reagent information 5 Load the plate into the instrument 6 Tap Start 7...

Page 106: ...e optimal dye concentration see Determine the optimal dye concentration on page 100 2 For more information see Troubleshoot calibration failure on page 89 10 Unload the plate from the instrument Note...

Page 107: ...ct account 114 If you link when you are signed in to the instrument 115 If you link when you are not signed in to the instrument 116 Manage individual instrument profiles 117 Manage all instrument pro...

Page 108: ...later time on the Connect platform Each person creates a profile Create a local instrument profile Connect enabled features are not available Optional Link a local instrument profile to a Connect prof...

Page 109: ...rator role Instrument profile Location Functions allowed Standard Connect Create save open import and run plate files Create and modify run settings View and export data files Administrator Connect Al...

Page 110: ...le to connect to the Connect platform will be displayed If the connection cannot be established Unable to connect will be displayed Chapter 8 Manage profiles Test the connection to the Connect platfor...

Page 111: ...ccount on a browser After the PIN is set up on the instrument it must be changed with your Connect account on a browser see Change the PIN for a Connect profile on page 119 The first time the instrume...

Page 112: ...ter Tap the Show PIN checkbox to show or hide the PIN 5 Optional Tap the Confirm PIN field enter the four digit numerical PIN again then tap Enter 6 Tap Done Create a new local instrument profile A lo...

Page 113: ...count It will apply to all other instruments when you use your Connect account This does not change the password when signing in to your Connect account on a browser After the PIN is set up on the ins...

Page 114: ...ts required field enter a four digit numerical PIN then tap Enter Tap the Show PIN checkbox to show or hide the PIN 6 Optional Tap the Confirm PIN field enter the four digit numerical PIN again then t...

Page 115: ...d to your Connect account User1 thermofisher com Your Connect instrument profile User G replaces your local instrument profile After you link Your Connect instrument profile User G and is displayed in...

Page 116: ...strument profile User G and is displayed in the home screen of the instrument Plate files and data files from your local instrument profile can be transferred to Connect New plate files and data files...

Page 117: ...ile is set up for facial authentication the photographs should reflect how the user appears in the lab For example safety glasses should be worn to set up facial authentication if safety glasses will...

Page 118: ...your face without any of the surrounding background This position is closer to the instrument than when you sign in with facial authentication The instrument will take three separate photos after you...

Page 119: ...iew all instrument profiles 1 In the home screen tap Profile The My Profile screen is displayed 2 Tap All accounts A list of all the profiles is displayed The following information is included for eac...

Page 120: ...dard role To enable administrator privileges see Enable or disable administrator privileges on page 120 Enable or disable administrator privileges Administrator privileges can only be enabled or disab...

Page 121: ...Tap a profile The Manage Account screen is displayed 4 Tap Delete account 5 Tap Yes to confirm The profile is delete and it is not listed on the My Profile screen Chapter 8 Manage profiles Manage all...

Page 122: ...rator with SAE enabled 133 Sign in with SAE enabled 134 Sign out with SAE enabled 135 Change your SAE account password on the instrument 136 Sign a plate setup 137 Enter an audit reason 138 View signi...

Page 123: ...user sign in and access to functions Auditing Tracks changes and actions performed by users E signature Allows users to provide an electronic signature user name and password when performing certain f...

Page 124: ...te a custom dye Start and stop an instrument run Calibration runs and RNase P verification runs Instrument configuration including the following functions Software update Network configuration Instrum...

Page 125: ...ns that can be signed Certain instrument functions can be signed This depends on how the SAE administrator has configured the e signature settings The following functions can be signed with an e signa...

Page 126: ...up for auditing and requires you to specify a reason for the action An action is set up for electronic signature and allows you to enter your password to allow the action If you do not have access to...

Page 127: ...tor functions The local instrument profiles and the Connect cloud based platform profiles are available if the SAE module is disabled SAE enabled system components Note SAE functions are not compatibl...

Page 128: ...components have conflicting SAE status some functions may not be available See the following table for more information Component Functionality with an SAE enabled plate or data file Functionality wi...

Page 129: ...SAE functions in QuantStudio Design and Analysis Software v2 page 131 Configure SAE Administrator Console application profiles Note Configuring application profiles in the SAE Administrator Console re...

Page 130: ...SAE Mode screen set the SAE Mode slider to Enable 3 Tap the Server IP field then enter the IP address of the SAE server 4 Tap the Port field enter the port then tap Next 5 Enter the SAE administrator...

Page 131: ...2 This procedure requires an SAE administrator account Before you enable SAE functions in the QuantStudio Design and Analysis Software v2 you must complete the following tasks Connect to the SAE serve...

Page 132: ...screen is displayed 2 In the SAE Mode screen set the SAE Mode slider to the Disable position then tap Done 3 Enter the password for the SAE administrator account then tap Disable The user name for the...

Page 133: ...ign in 1 1 Sign in for administrator The Local Administrator Sign In screen is displayed 2 In the Local Administrator Sign In screen select your local administrator profile 3 Enter your PIN then tap E...

Page 134: ...1 1 Sign in to an SAE account The SAE Sign In screen is displayed 2 In the SAE Sign In screen enter your SAE user name and your SAE password then tap Sign in Figure 16 SAE Sign In screen The home scre...

Page 135: ...d in is listed 1 2 Figure 18 My Profile screen 1 SAE button is active 2 Profile that is signed in 2 Tap Sign out then tap Yes to confirm You are signed out and the Sign in screen is displayed Chapter...

Page 136: ...d The SAE button is selected and the profile that is signed in is listed 1 2 Figure 19 My Profile screen 1 SAE button is active 2 Profile that is signed in 2 Tap Edit The Edit My Profile screen is dis...

Page 137: ...rd again then tap Enter 6 Tap Done Your SAE password will also be changed on the QuantStudio Design and Analysis Software v2 Sign a plate setup 1 In the home screen tap one of the following options Lo...

Page 138: ...st 7 Enter your SAE user name and password 8 Tap Sign plate Enter an audit reason Depending on the way that your SAE administrator configures audit settings the Enter Audit Reason screen may be displa...

Page 139: ...Drive USB 3 Tap the template file name in the right column The Plate Properties screen is displayed 4 In the Plate Properties screen tap Actions The Actions screen is displayed 5 Tap View signing reco...

Page 140: ...e viewed on the instrument touchscreen The audit records are viewed on the QuantStudio Design and Analysis Software v2 or on the SAE Administrator Console Chapter 9 Use the instrument with the Securit...

Page 141: ...s reconnected to the SAE server SAE records are uploaded to the server The following functions are not available when the SAE server is offline Account lockout password reminder mandatory password cha...

Page 142: ...screen sign in with a local administrator account 3 Set the correct IP address see Enable SAE on the instrument and specify the SAE server administrator only on page 130 There is a problem with the co...

Page 143: ...ombination of a block and an instrument has its own calibration status To determine the calibration status of a block on an instrument see View the calibration status and set reminders on page 81 To c...

Page 144: ...Chapter 7 Calibrate and verify instrument performance 1 Tap Settings 4Change block 2 In the Change Block screen tap Change then tap Ok The instrument unlocks the block and the heated cover This step...

Page 145: ...low it to cool to room temperature before handling This section describes removing the block and heated cover without installing another block and heated cover into the instrument 1 Tap Settings 4Chan...

Page 146: ...lf 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...

Page 147: ...lean surface 4 Rinse the contaminated wells with deionized water see Detailed procedures for cleaning the sample block on page 148 5 Install the block and heated cover see Install a block on page 143...

Page 148: ...se the well c Pipet the water to a waste beaker d Use a cotton swab to scrub inside of each contaminated well e Use a lint free cloth to absorb the excess deionized water Clean the sample block with 9...

Page 149: ...thead Replace the fuses 1 Power off then unplug the instrument 2 Allow the instrument cool for 15 minutes 3 Using a flat head screwdriver unscrew and remove the fuse holder 4 Remove each fuse from its...

Page 150: ...Request technical support with Smart Help on page 159 Power on or off store and move Enable and edit sleep mode Sleep mode allows the instrument to use less energy when not in use The length of time...

Page 151: ...ON OFF switch on the rear panel 1 Figure 21 Location of the ON OFF switch 1 ON OFF switch Note The length of time that the instrument is inactive before going into sleep mode can be customized see En...

Page 152: ...ent 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 alignm...

Page 153: ...data file 167 View the notifications 167 Enable and disable home screen notifications 168 Set up email notifications 168 Clear the notifications 169 View the instrument details 1 In the home screen ta...

Page 154: ...ettings screen View the license agreement 1 In the home screen tap Settings 4About instrument The About Instrument screen is displayed 2 Tap EULA The end user license agreement EULA is displayed 3 Opt...

Page 155: ...dministrator only 1 In the home screen tap Settings 4Instrument settings4Instrument name 2 Tap the Instrument name field then enter or edit the instrument name The instrument name must be unique if it...

Page 156: ...ated cover temperature 4 Tap Done Adjust the speaker volume The selected speaker volume is saved for each user When a new Connect profile is linked to the instrument the default speaker volume is set...

Page 157: ...r IT specialist before linking the instrument to a proxy server 1 In the home screen tap Settings 4Instrument settings4Proxy server The Network Configuration screen is displayed 2 Tap each field to en...

Page 158: ...n Note The system notifies a user when data files must be deleted see Delete data files from the instrument on page 77 3 Tap Done Enable and edit automatic sign out The automatic sign out feature sign...

Page 159: ...ings 4Instrument settings4Instrument access 2 Tap Generate code The instrument displays a new access code 3 Optional Set the Visible to all users slider 4 Tap Close In the external software that is be...

Page 160: ...the home screen tap Settings 4Maintenance and service4Smart Help The Smart Help screen is displayed 2 Tap Instrument service4Describe issue 3 Tap Edit 4 Enter a description in the Description field 5...

Page 161: ...ardware functions fail see Request technical support with Smart Help on page 159 View the last self verification test result The self verification test checks the instrument hardware functions You can...

Page 162: ...ype of event If an instrument event is not selected the logs for all the instrument events will be exported 3 Tap Export 4 Select a destination to save the instrument log files Connect Network Drive U...

Page 163: ...re available 1 1 Notifications including software updates To enable notifications to be displayed on the home screen see Enable and disable home screen notifications on page 168 1 In the home screen t...

Page 164: ...only be performed by an administrator IMPORTANT A back up of the instrument includes instrument profiles and settings It does not include plate files or data files Plate files and data files must be...

Page 165: ...nd service4Back up Restore4Restore a backup The Restore a Backup screen is displayed 2 Select the backup to restore 3 Tap Restore Your instrument has been restored is displayed on the Restore a Backup...

Page 166: ...tory default 2 Restart the instrument when prompted Configure the instrument for the hands free features The administrator must be signed in with a Connect profile in order to enable voice commands 1...

Page 167: ...the lines beside an attribute then drag the attribute above or below the other attributes in the table 1 1 Location to tap and drag an attribute The order of the attributes in the table is the order...

Page 168: ...ications will be sent to the email address associated with the Connect account 1 In the home screen tap Settings 4Email notifications Note If a user is not signed in with a Connect account the Email n...

Page 169: ...tions Option Description Clear a single notification Tap a single notification in the table then tap Clear Clear all the notifications Tap Clear all 3 Tap Close to return to the Settings screen Chapte...

Page 170: ...ns 170 Electrical requirements 173 Environmental requirements 174 Instrument dimensions The instrument including a block has a total weight of 35 85 kg 1 2 1 Height 54 7 cm 2 Width 33 7 cm A 170 Quant...

Page 171: ...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 5 cm 12 in 30 5 cm 12 in 15 25 cm...

Page 172: ...ument without a computer 1 2 1 Top clearance for the instrument 30 5 cm 2 Width of system 185 cm 1 4 2 3 1 Back clearance for the computer 15 25 cm 2 Back clearance for the instrument 15 25 cm 3 Front...

Page 173: ...ower 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 Electric receptacle required Grounding capabil...

Page 174: ...ransient category Installation categories II Overvoltage category Installation categories II Vibration The instrument is not adjacent to strong vibration sources such as a centrifuge pump or compresso...

Page 175: ...on describes direct wired connection of the computer provided by Thermo Fisher Scientific to the instrument or to a LAN Do not connect a customer provided computer to the instrument 1 Connect an Ether...

Page 176: ...the Default Gateway field 7 If your network requires advanced TCP IP setup such as WINS define the settings a Click Advanced in the Internet Protocol TCP IP Properties dialog box b Define the IP Sett...

Page 177: ...n the home screen tap Settings 4Instrument settings4Network configuration The Network Connections screen is displayed 2 Tap Edit 3 Tap one of the active fields found under the Wireless option 4 Select...

Page 178: ...anel 1 USB ports 2 Wi Fi dongle port 3 Ethernet port 4 RS 232 port service use only 5 ON OFF switch 6 Power inlet receptacle Appendix B Connect the instrument to a network Instrument and computer conn...

Page 179: ...installed on a customer provided computer The following list contains the minimum software requirements for a customer provided computer Operating system Windows 10 64 bit or Macintosh OS 10 01 Proces...

Page 180: ...tectures Because a network may contain advanced features such as a firewall or network domains we recommend that you consult a network administrator before connecting the instrument to your laboratory...

Page 181: ...N connection select an option Wired connection to the network using an Ethernet cable or Wireless connection to the network Instrument to LAN connection select an option Wired connection to the networ...

Page 182: ...port for the instruments to be discovered See Firewall ports that must be open on page 182 Observe the restrictions to mDNS and Autodiscovery The instrument supports mDNS but only when the instrument...

Page 183: ...linknlocal IPV4LL in the RFC also known as Automatic Private IP Addressing APIPA or Internet Protocol Automatic Configuration IPAC Note When an instrument is set for DHCP APIPA is automatically enabl...

Page 184: ...26659 MicroAmp EnduraPlate Optical 96 Well Clear GPLE Reaction Plates with Barcode 20 plates 4483348 500 plates 4483351 Instrument verification or calibration plate Cat No TaqMan RNase P Instrument Ve...

Page 185: ...io 5 Spectral Calibration Plate 1 FAM VIC ROX TAMRA and SYBR dyes 384 well A26334 QuantStudio 5 Spectral Calibration Plate 2 ABY JUN MUSTANG PURPLE NED and Cy 5 dyes 384 well A26335 96 well 0 1 mL con...

Page 186: ...n Plate 3 containing TAMRA NED and Cy 5 dyes A26340 96Well Fast TaqMan RNase P Instrument Verification Plate 4351979 Accessories Item Amount Cat No MicroAmp 96 Well Tray Retainer Set 10 trays 4381850...

Page 187: ...evice 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 th...

Page 188: ...CAUTION Ultraviolet light Symbole et description MISE EN GARDE Risque de danger Consulter le manuel pour d autres renseignements de s curit MISE EN GARDE Risque de choc lectrique MISE EN GARDE Surfac...

Page 189: ...labels The instrument contains warnings at the locations shown in the figures below 3 2 1 Figure 24 Labels on the back of the instrument QuantStudio 6 Pro Real Time PCR System 1 Electrical rating labe...

Page 190: ...ntStudio 7 Pro Real Time PCR System 1 Electrical rating label 2 RFID label 3 Safety label 1 Figure 26 Labels on the drawer 1 Moving parts label Appendix D Safety Symbols on this instrument D 190 Quant...

Page 191: ...27 Labels on the top of the block 1 Hot surface label Figure 28 Labels on the bottom of the block Appendix D Safety Symbols on this instrument D QuantStudio 6 Pro and 7 Pro Real Time PCR Systems User...

Page 192: ...installed block 1 Hot surface label 2 Moving parts label 1 Figure 30 Labels on the top of the heated cover 1 Hot surface label Appendix D Safety Symbols on this instrument D 192 QuantStudio 6 Pro and...

Page 193: ...ity with safety requirements for Canada and U S A Indicates conformity with China RoHS requirements Indicates conformity with European Union requirements Indicates conformity with Australia New Zealan...

Page 194: ...ve the 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...

Page 195: ...table grip on the instrument or accessory Make sure that the path from where the object is to where it is being moved is clear of obstructions Do not lift an object and twist your torso at the same ti...

Page 196: ...on of the instrument AVERTISSEMENT Veiller utiliser une alimentation lectrique appropri e Pour garantir le fonctionnement de l instrument en toute s curit Brancher le syst me sur une prise lectrique c...

Page 197: ...ser protection is defeated for servicing DO NOT operate the laser when it cannot be cooled by its cooling fan an overheated laser can cause severe burns on contact The following table lists laser safe...

Page 198: ...e pas utiliser d agents de nettoyage ou de d contamination susceptibles de r agir avec certaines parties de l appareil ou avec les mati res qu il contient et de constituer de ce fait un DANGER L instr...

Page 199: ...61010 2 081 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 081 Particular requirements for automatic and semi automatic laboratory equipment for analysi...

Page 200: ...onditions 1 This device may not cause harmful interference and 2 This device must accept any interference received Including interference that may cause undesired operation Changes and modifications n...

Page 201: ...dio lectrique subi m me si le brouillage est susceptible d en compromettre le fonctionnement This product complies to ICES 3 A NMB 3 A This equipment complies with ISED IC radiation exposure limits se...

Page 202: ...MHz Modulation ASK Transmit power 54 5 dBuV m at 10m Antenna 3674 000 00 ID ISC ANT40 30 HF PCB Antenna Dimensions 40 mm x 30 mm 1 57 inches x 1 18 inches Antenna 50 Ohm Supply voltage 12 Vdc Appendi...

Page 203: ...After emptying a waste container seal it with the cap provided Characterize by analysis if needed the waste generated by the particular applications reagents and substrates used in your laboratory En...

Page 204: ...m tiquement avec le couvercle fourni Caract riser par une analyse si n cessaire les d chets g n r s par les applications les r actifs et les substrats particuliers utilis s dans le laboratoire V rifie...

Page 205: ...iduals should be trained according to applicable regulatory and company institution requirements before working with potentially biohazardous materials Follow all applicable local state provincial and...

Page 206: ...v2 Standard Curve Analysis Module User Guide MAN0018746 QuantStudio Design and Analysis Software v2 Relative Quantification Analysis Module User Guide MAN0018747 QuantStudio Design and Analysis Softwa...

Page 207: ...DSs also known as MSDSs Note For SDSs for reagents and chemicals from other manufacturers contact the manufacturer Limited product warranty Life Technologies Corporation and or its affiliate s warrant...

Page 208: ...1 Frequency 82 Reminders 82 Run 86 Status 81 When to perform 80 Barcode scan 50 biohazard safety 205 Block Change 144 Clean 147 Remove 145 Block calibration 79 C calibration plate prepare 85 Calibrati...

Page 209: ...ilution plate Prepare plate 99 Run 100 Optimal concentration 100 Perform 102 Prepare plate 101 Workflow 98 Custom dyes Overview 98 Custom melt curve Calibrate 104 Cycles 55 D Data View during run 68 Z...

Page 210: ...AE 124 125 Fuses Replace Materials required 149 G Genotyping run 32 Guest access Edit 107 Overview 40 H Hands free Configure 166 Hands free features Facial authentication 21 Indicators 22 Voice activa...

Page 211: ...s 55 Method tab Actions Edit method 55 Move instrument 152 My instrument 26 N network configurations supported 180 guidelines and best practices 182 network configuration and security 13 Network conne...

Page 212: ...56 Remove pause 59 Remove PCR stage 56 Remove PCR step 56 Remove VeriFlex Zones 57 Repair software 164 Repeat last run 48 Replace fuses Materials required 149 Required materials Calibration 84 Reset i...

Page 213: ...e 158 Store instrument 152 support customer and technical 207 symbols conformity 193 control and connection 193 safety 188 189 system components SAE enabled 127 System dyes 15 System template Create a...

Page 214: ...View method during run 68 View notifications 167 View plots during run Zoom 69 View privacy policy 154 View time remaining during run 69 Voice commands Indicators 22 Overview 21 Supported 44 W warran...

Page 215: ......

Page 216: ...thermofisher com support thermofisher com askaquestion thermofisher com 27 April 2020...

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