Thermo Fisher Scientific VeritiPro™ Dx Thermal Cycler User guide

Brand: Thermo Fisher Scientific

Model: VeritiPro™ Dx Thermal Cycler

Type: User guide

For In Vitro Diagnostic Use.

VeritiPro™ Dx Thermal Cycler

USER GUIDE

For 96-well VeritiPro™ Dx Thermal Cyclers

Catalog NumberA55826

Publication Number MAN0028460

Revision D.0

UKRP

Life Technologies Limited | 3 Fountain

Drive, Inchinnan Business Park | Paisley

PA49RF, Scotland, United Kingdom

Life Technologies Europe B.V.

Kwartsweg 2, 2665 NN Bleiswijk The

Netherlands

Life Technologies Holdings Pte Ltd |

Block 33 | Marsiling Industrial Estate

Road 3 | #07-06, Singapore 739256

Revision history: MAN0028460 D.0 (English)

Revision Date Description

D.0 18 August 2023 Update of instrument speciﬁcations.

C.0 6 March 2023 Addition of EMC warnings on use of accessories, peripherals, and proximity of other equipment.

B.0 26 January 2023 Removal of instructions for multi-instrument setup feature.

A.0 30 November

2022 New product manual for the VeritiPro™ Dx Thermal Cycler.

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.

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.

Contents

■CHAPTER1Productinformation .................................................. 6

Productdescription ............................................................. 6

Intendeduse ................................................................... 6

Indications foruse ............................................................... 6

Special conditions statement ..................................................... 6

Instrument overview ............................................................. 7

■CHAPTER2Start, sign on, and conﬁgure theinstrument ....................... 8

Installation and instrument veriﬁcation ............................................. 8

Create userproﬁle ............................................................... 8

Create a user proﬁle on the instrument (Administrator proﬁleonly) ................. 8

Manage userproﬁles ........................................................ 9

Touchscreen controls ........................................................... 10

Home screen controls ...................................................... 10

Enter text ................................................................. 11

Enternumbers ............................................................ 11

Set up the wiredconnection ..................................................... 12

■CHAPTER3Methods ............................................................. 15

Create or edit amethod ......................................................... 15

Create a newmethod ...................................................... 16

Edit amethod ............................................................. 17

Save amethod ............................................................ 19

Actions ................................................................... 20

Manage methods andfolders ............................................... 26

Open and run amethod ......................................................... 31

Load samples into theinstrument ............................................ 31

Perform arun ............................................................. 31

Monitoring arun ........................................................... 33

View and export the run report .............................................. 34

Remove the samples from theinstrument ..................................... 34

VeritiPro™ Dx Thermal Cycler User Guide 3

■APPENDIXATroubleshooting .................................................... 35

Troubleshooting ................................................................ 35

Return an instrument for service ................................................. 37

■APPENDIXB Maintenance ....................................................... 38

Clean theinstrument ........................................................... 38

Preparation ............................................................... 38

Clean the touchscreen ..................................................... 38

Clean the samplewells ..................................................... 39

Decontaminate the samplewells ............................................. 39

Clean the heatedcover ..................................................... 39

Decontaminate the heatedcover ............................................ 40

Replace thefuses .............................................................. 41

Required materials ......................................................... 41

Procedure ................................................................ 41

Request maintenance support ................................................... 42

Perform self veriﬁcation test ..................................................... 42

Restore factory settings (Administrator proﬁle only)................................. 43

■APPENDIXCRecommended instrumentsettings .............................. 44

AboutInstrument .............................................................. 44

Recommended instrumentsettings .............................................. 44

InstrumentSettings ....................................................... 45

Maintenance and services ....................................................... 49

Run history .................................................................... 50

USB shortcuts ................................................................. 51

■APPENDIXDInstrument speciﬁcation andlayout .............................. 53

Site requirements .............................................................. 53

Environmental requirements ..................................................... 53

Temperature and humidity requirements ...................................... 53

Transportationconditions ................................................... 53

Pollution .................................................................. 53

Altitude ................................................................... 54

Speciﬁcations ................................................................. 54

Technicalspeciﬁcations .................................................... 54

Physicaldimensions ....................................................... 55

Power and communication portsymbols .......................................... 55

Location of power point and ports on theinstrument ............................... 56

Contents

4VeritiPro™ Dx Thermal Cycler User Guide

■APPENDIXEHow to use the MicroAmp™ 96-well Tray andRetainer ........ 57

Prepare samples using MicroAmp™ tubes/tube strips with separate capstrips ......... 58

Prepare samples using MicroAmp™ tube strips with attachedcaps ................... 60

Seal tube strips with capstrips .................................................. 62

Prepare samples using MicroAmp™ Reaction Tubes ................................ 63

■APPENDIXFOrderinginformation ............................................... 64

Instrument partnumbers ........................................................ 64

Consumables .................................................................. 64

■APPENDIXGSafety ............................................................... 66

Symbols on theinstrument ...................................................... 66

Safety symbols on thisinstrument ................................................ 67

Location of safety labels on theinstrument .................................... 67

Safety information for instruments not manufactured by Thermo FisherScientiﬁc ...... 68

Instrumentsafety .............................................................. 68

General ................................................................... 68

Physical injury ............................................................. 69

Electricalsafety ........................................................... 69

Cleaning anddecontamination .............................................. 69

Safety and electromagnetic compatibility (EMC) standards .......................... 69

Safety .................................................................... 70

EMC ..................................................................... 70

Class Anotice ............................................................. 71

Environmental design standards ............................................. 71

Chemicalsafety ................................................................ 72

Biological hazardsafety ......................................................... 73

■APPENDIXHDocumentation and support ...................................... 74

Customer and technical support ................................................. 74

Seriousincidents .............................................................. 74

Limited product warranty ........................................................ 74

Contents

VeritiPro™ Dx Thermal Cycler User Guide 5

Product information

Product description

The Applied Biosystems™ VeritiPro™ Dx Thermal Cycler is an end-point thermal cycler with a 96-well

VeriFlex™ block (Cat. No. A55826), speciﬁcally designed for the ampliﬁcation of nucleic acids using the

Polymerase Chain Reaction (PCR) process. The user interface includes a touchscreen with a graphical

display that shows the time, status, and temperature for each run. A touchscreen keypad allows you to

enter information into ﬁelds on the display screen.

Intended use

The semi-automated Applied Biosystems™ VeritiPro™ Dx Thermal Cycler is an in vitro diagnostic device

intended to amplify nucleic acid from human-derived specimens. The Applied Biosystems™ VeritiPro™

Dx Thermal Cycler is intended for use by trained professionals in laboratory techniques and procedures.

Indications for use

Same as Intended purpose.

Special conditions statement

For in vitro diagnostic use.

6VeritiPro™ Dx Thermal Cycler User Guide

Instrument overview

The VeritiPro™ Dx Thermal Cycler allows you to:

•Set the instrument secuity mode to safeguard the integrity of validated protocols

•Optimize your PCR with the help of the VeriFlex™ block

•Program the instrument from the touchscreen interface

•Simulate Veriti™ Dx 96‑well Thermal Cycler, 0.2 mL PCR instrument with Thermal Simulation mode

Figure1VeritiPro™ Dx Thermal Cycler

This user guide provides information on how to maximize the capabilities of this system.

For detailed speciﬁcations of the VeritiPro™ Dx Thermal Cycler, see Appendix D, “Instrument

speciﬁcation and layout”.

Chapter1Product information

Instrument overview 1

VeritiPro™ Dx Thermal Cycler User Guide 7

Start, sign on, and conﬁgure the

instrument

Installation and instrument veriﬁcation

The instrument is installed by a representative from Thermo Fisher Scientiﬁc. The following tasks will be

performed during the installation process:

•Unpack and install the instrument

•Set up an instrument administrator proﬁle

•Perform operational and performance qualiﬁcations

If it is necessary to move the instrument to a new location after installation, contact your Thermo Fisher

Scientiﬁc representative.

Create user proﬁle

The ﬁrst proﬁle created on the instrument during set up is automatically given an Administrator proﬁle

(indicated by an asterisk after the Username).

Additional proﬁles can be created depending upon the needs of the user.

There are two user types (Standard and Administrator) with dierent levels of access to folders and

instrument functionality.

Create a user proﬁle on the instrument (Administrator proﬁle only)

1. Select (Username) > All accounts4Add proﬁle.

2. Fill in the required text ﬁelds and enter a password to create your user proﬁle.

Use a minimum of 8 alphanumeric characters for the password.

The personal folder created during this step becomes the default folder for the user. Standard

users can only save methods to their personal folders.

8VeritiPro™ Dx Thermal Cycler User Guide

Manage user proﬁles

All users can manage their proﬁles to edit personal folder names and change passwords by selecting

their (Proﬁle) to enter their My Proﬁle page.

Users with Administrator proﬁles (as indicated by an asterisk after their user name) also have the ability

to manage all user accounts by selecting All accounts after entering their My Proﬁle page.

Users have the ability to perform the following functions depending upon their user type.

Admin users Standard users

•Change personal password.

•Assign default folder to user proﬁles.

•Create new user proﬁles.

•Grant Administrator privileges to user proﬁles.

•Delete passwords (this function eectively resets a password, so the

user with a deleted password will need to create a new password the

next time they log in).

•Delete user accounts.

•Manage all user folders.

•Change personal

password.

•Select default folder

•Manage personal

folders.

Chapter2Start, sign on, and conﬁgure the instrument

Create user proﬁle 2

VeritiPro™ Dx Thermal Cycler User Guide 9

Touchscreen controls

Table1General touchscreen controls

Button Function

Returns to the previous screen

Go to Home screen

Go to Sign in screen

Go to Settings screen

Advance and return through stages

Close the current modal window.

Home screen controls

Table2Home screen controls and indicators

Button Function

Go to Set up run screen

View instrument status

1. Current block temperature

2. Time remaining

3. Status of the block (pre-heating, running, etc.)

Go to Sign in screen

Go to Settings screen

Indicates whether a USB device is inserted into the instrument.

Indicates whether the instrument is connected to the network.

Chapter2Start, sign on, and conﬁgure the instrument

Touchscreen controls

10 VeritiPro™ Dx Thermal Cycler User Guide

Enter text

When you select a ﬁeld that requires the input of text, the alphanumeric text editor, as seen in the

following ﬁgure, opens.

2 3 5 4

1 6

1Enter a letter

2Change letter case

3Enter punctuation or other symbols

4Delete

5Close and save

6Close without saving

Enter numbers

When you select a ﬁeld that requires a numerical input, the numeric editor, as seen in the following

ﬁgure, opens.

32 1 4

1Enter a number

2Delete/backspace

3Close and save

4Close without saving

Chapter2Start, sign on, and conﬁgure the instrument

Touchscreen controls 2

VeritiPro™ Dx Thermal Cycler User Guide 11

Set up the wired connection

IMPORTANT! The network conﬁguration and security settings for your laboratory or facility (such as

ﬁrewalls, antivirus software, network passwords) are the sole responsibility of your facility administrator,

IT, and security personnel.

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

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

1. Connect the instrument to a network.

a. Connect an ethernet cable to the ethernet port on the instrument.

b. Connect the ethernet cable to the ethernet port wall plug.

1Ethernet port

2. On the Home screen, select (Settings).

Chapter2Start, sign on, and conﬁgure the instrument

Set up the wired connection

12 VeritiPro™ Dx Thermal Cycler User Guide

3. In the Settings screen, select Instrument Settings.

4. In the Instrument Settings screen, select Network conﬁguration.

5. In the Network Connection screen, select a ﬁeld in the Wired panel.

6. Select a method to enter an IP address.

a. Select DHCP to obtain an IP address automatically.

Chapter2Start, sign on, and conﬁgure the instrument

Set up the wired connection 2

VeritiPro™ Dx Thermal Cycler User Guide 13

b. Select Static IP to enter an IP address manually, then enter the appropriate IP addresses

for the instrument, the Subnet Mask, and, optionally, the Default Gateway, the Primary DNS

Server, and the Secondary DNS Server using the numeric editor. Addresses are in the form of

X.X.X.X, where each X is a 3- digit number, from 001 to 255.

Note: If your instrument is not on a network, you do not need to set the IP address. Ask your

system administrator if the IP address is assigned statically or dynamically. For static addresses,

you need to know the IP address for the instrument, the subnet mask, and the default gateway.

7. Select Done to save the changes and go back to the Instrument Settings screen or select Cancel

to exit the screen without saving the changes.

Chapter2Start, sign on, and conﬁgure the instrument

Set up the wired connection

14 VeritiPro™ Dx Thermal Cycler User Guide

Methods

Create or edit a method

A method is the protocol that controls the parameters for the execution of the PCR run on the

instrument.

•Select any ﬁeld on the graphical method proﬁle to edit the parameter (temperature, time, heated

cover, number of cycles, and volume).

•Select Actions (see “Actions” on page20) to manage steps, stages, and advanced options.

•Select Cancel to exit without making changes.

•Select Save as/Save to save a new or updated method.

Note: Standard users can only save ﬁles to personal folders.

•Select Start Run to run a method.

1Temperature (step)

2Time (step)

3Heated cover (temperature)

4Number of cycles (stage)

5Volume (PCR reaction)

VeritiPro™ Dx Thermal Cycler User Guide 15

Create a new method

1. In the Home screen, select Set up run or New method.

2. In the Setup Run screen, select (Open Template).

3. Select a template from the Method Name list.

Chapter3Methods

Create or edit a method

16 VeritiPro™ Dx Thermal Cycler User Guide

4. Select Actions (see “Actions” on page20) or any ﬁeld on the graphical temperature proﬁle to start

editing the parameters.

5. Select Save as, see “Save a method” on page19.

6. (Optional) Select Cancel to exit without making changes, or Start Run to run the method.

Edit a method

1. In the Home screen, select Set Up Run or Open method.

Chapter3Methods

Create or edit a method 3

VeritiPro™ Dx Thermal Cycler User Guide 17

2. In the Setup Run screen, select (Open Method).

3. Select a folder , then select an appropriate template from the Method Name list.

Note: At least one method must have previously been set up in order for the list to be populated.

4. Select Actions (see “Actions” on page20) or any ﬁeld on the graphical temperature proﬁle to start

editing the parameters.

Chapter3Methods

Create or edit a method

18 VeritiPro™ Dx Thermal Cycler User Guide

5. Select Save, see “Save a method” on page19.

6. (Optional) Select Cancel to exit without making changes, or Start Run to run the method.

Save a method

1. Once edits to a method are complete, select Save As/Save to save the method.

2. In the Save As/Save screen, enter a name for the edited method.

Characters allowed Characters not allowed

<100 characters >100 characters

Letters, numbers, spaces, underscores, and

dashes

% * ? | ; : , ! @ # $ . ( ) < > / \ " ' ` ~ { } [ ] = + & ^ (tab)

3. Select , then select the destination folder where you want to save the method, then select Save.

Chapter3Methods

Create or edit a method 3

VeritiPro™ Dx Thermal Cycler User Guide 19

Actions

Select Actions to edit the parameters of a method. Options can be used to:

•Add or remove stages and steps

•Perform temperature optimization (manage VeriFlex™ block zones)

•Change ramp rates

•Increase or decrease time and temperature (manage AutoDelta)

•Run in simulation mode

•Add comments

Manage stages and steps

1. Select Stages and steps to open the Manage steps screen.

2. Select an option to manage stages and steps.

Select Description

Add/Remove Steps, then or To add/delete a step

Add/Remove Stages, then or To add/delete a stage

Chapter3Methods

Create or edit a method

20 VeritiPro™ Dx Thermal Cycler User Guide

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Thermo Fisher Scientific VeritiPro™ Dx Thermal Cycler User guide

Brand: Thermo Fisher Scientific

Model: VeritiPro™ Dx Thermal Cycler

Type: User guide

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