Thermo Fisher Scientific VeritiPro™ Dx Thermal Cycler User guide

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.
©2022-2023 Thermo Fisher Scientific Inc. All rights reserved.
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.
1
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 96well 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.
2
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
1
2
3
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
2
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.
1
1Ethernet port
2. On the Home screen, select (Settings).
Chapter2Start, sign on, and configure the instrument
Set up the wired connection
2
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
2
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.
3
2
1
4
5
1Temperature (step)
2Time (step)
3Heated cover (temperature)
4Number of cycles (stage)
5Volume (PCR reaction)
3
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
3
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
3
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
3
20 VeritiPro Dx Thermal Cycler User Guide
  • Page 1 1
  • Page 2 2
  • Page 3 3
  • Page 4 4
  • Page 5 5
  • Page 6 6
  • Page 7 7
  • Page 8 8
  • Page 9 9
  • Page 10 10
  • Page 11 11
  • Page 12 12
  • Page 13 13
  • Page 14 14
  • Page 15 15
  • Page 16 16
  • Page 17 17
  • Page 18 18
  • Page 19 19
  • Page 20 20
  • Page 21 21
  • Page 22 22
  • Page 23 23
  • Page 24 24
  • Page 25 25
  • Page 26 26
  • Page 27 27
  • Page 28 28
  • Page 29 29
  • Page 30 30
  • Page 31 31
  • Page 32 32
  • Page 33 33
  • Page 34 34
  • Page 35 35
  • Page 36 36
  • Page 37 37
  • Page 38 38
  • Page 39 39
  • Page 40 40
  • Page 41 41
  • Page 42 42
  • Page 43 43
  • Page 44 44
  • Page 45 45
  • Page 46 46
  • Page 47 47
  • Page 48 48
  • Page 49 49
  • Page 50 50
  • Page 51 51
  • Page 52 52
  • Page 53 53
  • Page 54 54
  • Page 55 55
  • Page 56 56
  • Page 57 57
  • Page 58 58
  • Page 59 59
  • Page 60 60
  • Page 61 61
  • Page 62 62
  • Page 63 63
  • Page 64 64
  • Page 65 65
  • Page 66 66
  • Page 67 67
  • Page 68 68
  • Page 69 69
  • Page 70 70
  • Page 71 71
  • Page 72 72
  • Page 73 73
  • Page 74 74
  • Page 75 75
  • Page 76 76

Thermo Fisher Scientific VeritiPro™ Dx Thermal Cycler User guide

Type
User guide

Ask a question and I''ll find the answer in the document

Finding information in a document is now easier with AI