Agilent AriaDx Real-Time PCR User Manual

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AriaDx Real-Time PCR System

Setup and User Guide

For In Vitro Diagnostic Use

Version F0, March 2021

Intended Use / Indications for Use

The AriaDx Real-Time PCR Dx instrument is a fully integrated quantitative PCR amplification, detection, and data analysis system for nucleic acids samples.

The instrument is to be used only by operators trained in laboratory techniques and procedures.

The customer is responsible for validation of assays and compliance with regulatory requirements that pertain to their procedures and uses of the instrument.

Notice

Each laboratory must validate their own assays for use on the AriaDx Real-Time PCR System. Assays must include controls designed to detect inconsistencies in instrument performance due to, for example, changes in optical performance or thermal block uniformity.

Symbol Table

European Conformity Caution

In Vitro Diagnostic Medical Device Catalog/code number

Manufacturer Consult Instructions for Use

Authorized representative in the European Community

Temperature limitation

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Content

Contents

1 Before You Begin

Overview of the AriaDx Real-Time PCR System 7 Materials provided with the AriaDx Real-Time PCR System 7 Hardware specifications 8 Recommended plasticware 8 Safety precautions 9 Indicator LED light 11 Agilent Technical Support 12

2 Installing and Setting Up the AriaDx Instrument

Installing the AriaDx Instrument 14

Step 1. Select a location for the instrument 14 Step 2. Unpack the shipping containers 14 Step 3. Install the optical modules 16 Step 4. Clean the thermal block 19 Step 5. Connect the instrument to a power supply 20 Step 6. Connect a keyboard or mouse to the instrument (optional) 20 Step 7. Connect the instrument to a network or directly to a PC 20

Setting Up the AriaDx Instrument 23

Step 1. Turn on the instrument and calibrate the background for the optical modules 23 Step 2. Set the instrument date and time 23 Step 3. Run a diagnostic check 24

Logging In and Creating User Accounts 25

Step 1. Log in to the instrument using an Administrator account 25 Step 2. Add user accounts 26 Step 3. Log in to your personal user account 26

Customizing Instrument Settings 27

3 Installing the Aria Software

Minimum requirements for running the Aria software 29

Installing the Standard Aria Software 30

Download the Aria software 30 Install the standard Aria software 30 Launch the Aria software 34

Installing the Aria ET (Electronic Tracking) Software 35

Download the Aria software and Microsoft SQL Server 2012 35

AriaDx Real-Time PCR System Setup and User Guide 3

Install Microsoft SQL Server 2012 35 Install the Aria ET software 39 Configure and start Microsoft Distributed Transaction Coordinator (MSDTC) service 44 Launch the Aria ET software 47

Installing Microsoft .NET Framework 4.0 49

Download Microsoft .NET Framework 4.0 49 Install Microsoft .NET Framework 4.0 49

4 Running Experiments

Preparing and Loading PCR Samples 53

Prepare samples 53 Load samples 53

Setting Up and Running Experiments 54

Use the touchscreen to set up and run an experiment 54 Use the PC software to set up and run an experiment 54

Managing Saved Experiments 56

Locate saved experiment files 56 Create a subfolder 56 Copy and paste experiments 57 Transfer experiments to a USB drive 57

5 Calibrating the AriaDx System

Calibrating the Instrument Motor 59

Calibrate the motor 59 Check the motor calibration date 59

Calibrating the Background 60

Calibrate the background 60 Check the background calibration status 60

Performing Other Calibration Procedures 61

Calibrate the touchscreen 61 Calibrate the analysis of high resolution melt data 61

6 Maintaining, Updating, and Disposing of the AriaDx System

Maintaining the Instrument 63

Service the instrument 63 Clean the instrument 63 Clean the optical modules 63

Updating the Instrument Software 65

Disposing of Instrument Parts 66

Cybersecurity Guidance 67

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7 Troubleshooting

Troubleshooting Instrument Error Messages 69

View error messages 69 Open the diagnostic report 69

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AriaDx Real-Time PCR System Setup and User Guide

1 Before You Begin

This chapter contains information for you to read and understand before you start setting up the instrument.

Overview of the AriaDx Real-Time PCR System

The AriaDx Real-Time PCR System is a fully integrated quantitative PCR amplification, detection, and data analysis system. The system design combines a thermal cycler, an optical system with an LED excitation source, and data analysis software. The instrument can hold up to six optics modules, and the scanning optics design delivers optimal separation between the dyes and between samples. The instrument provides a closed-tube PCR detection format that can be used with a variety of fluorescence detection chemistries including SYBR® Green and EvaGreen dyes as well as fluorogenic probe systems including TaqMan probes.

Materials provided with the AriaDx Real-Time PCR System

Table 1 Materials provided

Materials provided Quantity

AriaDx instrument 1

Certificate of Conformance 1

AriaDx installation poster 1

Power cord 1

Optical modules Up to 6 optical modules, as selected by the user

The AriaDx instrument, the Certificate of Conformance, and the AriaDx installation poster are all shipped together in the same shipping container. The power cord and optical modules are each shipped in their own packaging.

Table 2 Materials offered as options at time of purchase

Options Quantity

Electronic tracking (ET) software 1 seat

Notebook PC 1

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Hardware specifications

Table 3 Hardware specifications for the AriaDx Real-Time PCR System

Feature Specification

Excitation source Eight dye-specific LEDs per optical module

Detection Eight photodiodes per optical module

Dyes ROX, FAM, HEX, CY5, CY3, ATTO 425

Electrical power (input) 100–240 VAC, 50/60 Hz, 1100VA

Thermal system Peltier-based, 96-well block

Six slots, swappable cartridges, no reference channel needed

Thermal system temperature range

Cycling speeds 40 cycle protocol in 43 minutes

Storage environment 10–43°C (50–109°F); 10–90% non-condensing humidity

Operating environment 20–30°C (68–86°F); 20–80% non-condensing humidity;

Weight 50 lbs (23 kg)

Dimensions 19.7" W × 18.1" D × 16.5" H (50 cm × 46cm × 42cm)

On board quality checks Instrument QC checks:

Warranty One year warranty

Plastic consumables Low-profile 0.2-ml tubes, strip tubes, and 96-well plates

25.0–99.9°C Max Heating: >6°C/sec Max Cooling: >2.5°C/sec Accuracy: ±0.2°C or better at typical annealing, amplification, and denaturation temperatures

maximum altitude of 2000 m

All checks: 30 minutes; Selected checks: 10–30 minutes

Calibration: 1-minute background calibration

Data loss prevention: Data captured from all channels on each scan Ability to store up to 5 GB on the instrument

See “Recommended plasticware” on page 8 for part numbers

Recommended plasticware

Table Table 4 lists the part numbers of Agilent plates, tubes, and other plastic consumables for use in the AriaDx instrument.

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Table 4 QPCR plasticware for use in the AriaDx instrument

Agilent Part Number

401490 96-well plate, fully skirted, low profile

401491 96-well plate, rigid, fully skirted, low profile

401494 96-well plate, non-skirted, low profile

401493 8x strip tubes, without caps, low profile, 120 strips (10 packs of 12 strips)

401425 8x strip tube optical caps, 120 strips (10 packs of 12 strips)

401427 8x strip tube optical caps, 60 strips (5 packs of 12 strips)

401492 Adhesive seal for 96-well plates, 50-pack

Safety precautions

This product is designed for convenient and reliable operation, and to accepted standards of safety. Its use does not entail any hazard if operated in accordance with the instructions given in this document. However, incorrect operation may cause damage to the equipment or cause a hazard to health. It is important that the following safety precautions are read and understood before using the instrument.

Description

When sealing plates with adhesive seals, Agilent recommends using MicroAmp Optical Film Compression Pads (Life Technologies, part number 4312639).

All users must read and understand the Setup and User Guide and only operate the unit in accordance with the instructions given. Failure to follow instructions may cause the protection provided by the instrument to be impaired.

Electrical

Standard electrical safety precautions should be applied, including the following:

• Always put the instrument in a location where, if needed, the power supply can be immediately disconnected.

• Proper voltage (100–240 VAC) must be supplied before you turn on the instrument for the first time.

• The device must be connected to a grounded socket. Do not operate the instrument from a power outlet that has no ground connection.

• Do not touch any switches or outlets with wet hands.

• Turn off the instrument before you disconnect the power cord.

• Unplug the instrument before you clean any major liquid spills and before you service any of

the electrical or internal components.

• Do not connect the instrument to the same power strip as other high power-draw appliances (e.g., refrigerators and centrifuges).

• Do not service the electrical components unless you are qualified to do so.

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Fluids and Reagents

• Fill reaction vessels outside the instrument so that no fluids penetrate the instrument.

• Never cycle or incubate explosive, flammable and reactive substances in the instrument.

• You must observe the relevant safety regulations when handling pathogenic material,

radioactive substances or other substances hazardous to health.

• Do not submerge the instrument in any liquid.

Danger of Burns

• Do not touch the thermal block, inner side of heated lid and reaction vessels. These areas

quickly attain temperatures of greater than 50°C. Keep the heated lid closed until temperatures of 30°C or lower are reached.

• Do not use any materials (plates, sealings, foils, mats) which are not sufficiently temperature-stable (up to 120°C).

Operating Environment

• The ventilation slots of the device must remain free to vent at all times. Leave at least 10 cm of

space around the instrument.

• Keep the ambient temperature between 20°C and 30°C with humidity levels between 20% and 80% non-condensing.

• Do not operate the instrument in a hazardous or potentially explosive environment.

• Do not attempt to open the instrument door when the instrument is running an experiment.

Equipment Ratings

• Pollution degree 2

• Installation category II

• Altitude 2000 m

• Humidity 20 to 80%, non-condensing

• Electrical supply 100-240 VAC, 50/60 Hz, 1100VA

• Temperature 20°C to 30°C

• For Indoor Use Only

Electrostatic Discharge

The instrument is static sensitive. Electrostatic discharges greater than 8000 volts may interfere with the normal operation of the USB ports on the instrument. Handling precautions are required when working in high static environments. Wear a grounded wrist strap and take other antistatic precautions prior to making contact with the device in high static environments. ESD STM5.1-1998 Class 3B.

The AriaDx Real-Time PCR System complies to IEC 61326-2-6 standards that governs Electromagnetic Compliance for IVD medical equipment. This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. It is therefore advisable to choose a suitable electromagnetic environment for the AriaDx instrument prior to use.

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Safety Symbols

The electrical/safety symbols described below may be displayed on the instrument.

Indicator LED light

Power on

Power off

Caution

Caution, hot surfaces

On the front of the instrument (top right corner) is a status indicator LED. Table 5 summarizes the status codes for this LED light.

Table 5 Appearance of the status indicator LED

Appearance Instrument Status

Off The instrument is idle.

Blinking green The instrument is running.

Solid green The instrument is paused.

Blinking red The instrument has detected an error. Check the display for an error

message containing further details.

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Agilent Technical Support

Agilent Technical Support is available worldwide.

For US and Canada

Call (800)227-9770 (option 3,4,3)

Or send an e-mail to qPCR.support@agilent.com.

For all other regions

Agilent’s world-wide Sales and Support Center contact details for your location can be obtained at

www.agilent.com/en/contact-us/page.

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AriaDx Real-Time PCR System Setup and User Guide

2 Installing and Setting Up the AriaDx Instrument

Installing the AriaDx Instrument 14 Step 1. Select a location for the instrument 14 Step 2. Unpack the shipping containers 14 Step 3. Install the optical modules 16 Step 4. Clean the thermal block 19 Step 5. Connect the instrument to a power supply 20 Step 6. Connect a keyboard or mouse to the instrument (optional) 20 Step 7. Connect the instrument to a network or directly to a PC 20 Setting Up the AriaDx Instrument 23 Step 1. Turn on the instrument and calibrate the background for the optical modules 23 Step 2. Set the instrument date and time 23 Step 3. Run a diagnostic check 24 Logging In and Creating User Accounts 25 Step 1. Log in to the instrument using an Administrator account 25 Step 2. Add user accounts 26 Step 3. Log in to your personal user account 26 Customizing Instrument Settings 27

This chapter contains instructions for installing and setting up the AriaDx instrument.

Installing the AriaDx Instrument

Step 1. Select a location for the instrument

• Locate a solid, flat clean surface for the instrument. Make sure that:

• The instrument can stand completely stable.

• The rear air slots must not be covered.

• The instrument has at least 10 cm (approximately 4 inches) to the next wall or neighboring

instrument.

• The instrument is not located near anything that could be a source of vibrations.

• The temperature (normal ambient) is between 20°C and 30°C with humidity levels between

20% and 80% non-condensing.

• The atmosphere is not explosive.

Step 2. Unpack the shipping containers

NOTE

1 Open the small shipping container that holds the power cord. Remove the power cord and set

it aside for now.

2 Make sure that the large shipping container is in the upright position (Figure 1), then cut the

four plastic straps that hold the container together.

The AriaDx instrument is shipped in two separate containers. The small container holds the power cord. The large container holds the instrument and accessory tray.

Any optical modules that you ordered with the instrument are each packed and shipped separately in their own box.

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Figure 1 AriaDx instrument shipping container

3 Open the top flaps of the large container.

Inside the container is an accessory tray (see Figure 2), which contains the Certificate of Conformance and the installation poster.

Figure 2 Opened shipping container with accessory tray sitting on top

4 Remove the accessory tray. Unpack the installation poster from the accessory tray and use it

to guide you through the remainder of the unpacking process.

5 Remove the foam support that sits on top of the instrument in the shipping container.

6 Grip a handle on each side of the shipping container and lift up to remove the box sleeve that

surrounds the instrument. The instrument sits on the base of the shipping container, as shown in Figure 3.

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Figure 3 Instrument on shipping container base, with box sleeve removed

7 Remove the plastic wrapping from the instrument.

8 Lift the instrument off of the shipping container base and set it down on its selected location

(see “Step 1. Select a location for the instrument”).

Agilent recommends that two people lift the instrument together.

Step 3. Install the optical modules

1 Open the instrument door by lifting up on the handle on the top of the instrument. Lift the door

all the way up and back.

2 Remove the piece of foam and then remove the strip of cardboard from around the thermal

block assembly (see Figure 4). The optical module housing carrier is positioned to the left of the thermal block assembly.

Figure 4 Foam insert (left) and underlying cardboard strip (right).

3 Slide the optical module housing carrier to the right until it is centered in the opening of the

instrument door (as shown in Figure 5). Use the indentation on the top of the carrier to help slide it.

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Figure 5 Optical module housing carrier, centered in the instrument door opening

4 Open the lid on the optical module housing carrier.

a With your thumb and index finger, pinch together the two pieces of plastic in the indentation

on the top of the carrier (see Figure 6).

b Lift the lid all the way back to reveal the six slots for the optical modules (see Figure 7).

Figure 6 Opening of the optical module housing

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Figure 7 Slots for the optical modules

5 Open the boxes containing the optical modules. Remove the top piece of foam from each box

(Figure 8) then remove the plastic bag containing the optical module.

Figure 8 Optical module shipping box – top piece of foam removed

6 Install the optical modules into the slots.

a Open the plastic bag and remove the optical module.

b Peel off the plastic film from the edge of the optical module (see Figure 9). Once the film is

removed, do not to touch the exposed edge.

c Put the optical module into an available slot in the optical module housing. The correct

orientation for the optical module is label side up with the Agilent spark closer to the front of the instrument (see Figure 10).

NOTE

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If you are installing fewer than six optical modules, one or more of the slots in the optical module housing will be empty. In such cases, make sure that the empty slots are on the left-most side of the housing.

Figure 9 Removal of plastic film from optical module

Figure 10 Installed optical modules

7 Lower the lid on the optical module housing until it clicks shut.

When you turn on the instrument for the first time, it will prompt you to calibrate the background for the optical modules. Calibration is described in “Step 1. Turn on the instrument

and calibrate the background for the optical modules” on page 23.

Step 4. Clean the thermal block

With the instrument door still open, clean the outside and inside surfaces of the thermal block.

1 Lift the lid of the thermal block by pulling forward on the handle of the lid and then lifting the lid

up and away from the thermal block.

2 Using an aerosol can of compressed air, clean out the wells of the thermal block. Hold the can

8–10 cm away from the thermal block as you press the trigger.

3 Moisten a lint-free cleansing tissue with deionized H20, and gently wipe down the thermal

block and the underside of the lid. Then, close the lid of the thermal block and wipe down the top of the lid.

4 Close the instrument door.

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Step 5. Connect the instrument to a power supply

You must connect the instrument to a grounded AC outlet.

1 Plug the power cord into the power connector at the rear of the instrument.

See “Electrical” on page 9 for information on electrical safety precautions.

2 Connect the cable plug to the outlet.

Step 6. Connect a keyboard or mouse to the instrument (optional)

If desired, you can connect a keyboard or mouse to the instrument via the USB ports on the front and back of the instrument.

• Plug the USB cable of the device into a USB port on the instrument.

Multimedia keyboards are not supported.

Step 7. Connect the instrument to a network or directly to a PC

Connecting your instrument to a PC, either directly or though a network, allows you to remotely retrieve data from the instrument to your PC through the Aria PC software. If you do not connect your instrument to a PC or network, you must transfer post-run experiment data by copying it from the instrument to a USB drive (FAT format), and then from the USB drive to your PC.

To connect the instrument to a network

1 Plug one end of an ethernet cable into the ethernet port on the back of the instrument. Use a

standard Cat 6 straight/crossover ethernet cable.

2 Plug the other end of the cable into a network port.

To connect the instrument directly to a PC

1 Plug one end of an ethernet cable into the ethernet port on the back of the instrument. Use a

standard Cat 6 straight/crossover ethernet cable.

2 Plug the other end of the cable into the PC.

3 After you turn on the AriaDx instrument, set a static IP address, subnet mask, and default

gateway on the instrument using the instructions below. You will need to wait to complete these steps until after you complete “Step 1. Turn on the

instrument and calibrate the background for the optical modules” on page 23.

a On the Home screen of the AriaDx touchscreen, press Settings.

b Press Connection Settings. If you see an error message that no network connection is

detected, press OK to close the error message.

c On the Connection Settings screen, select Use Manual Configuration.

d In the IP Address, Subnet Mask, and Default Gateway fields, enter the values shown in

Figure 11. Press OK.

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Figure 11 Connection Settings

4 On the PC, set a static IP address, subnet mask, and default gateway using the instructions

below.

a Open the Control Panel to the Network and Sharing Center.

b Under View your active networks, click Local Area Connection (Figure 12). Note that the

appearance of the Network and Sharing Center screen may differ slightly from that shown in Figure 12 depending on your current network setup.

Figure 12 Network and Sharing Center – View your active networks

The Local Area Connection Status dialog box opens.

c In the Local Area Connection Status dialog box, click Properties.

The Local Area Connection Properties dialog box opens

d In the list of items under This connection uses the following items, double-click Internet

Protocol Version 4 (TCP/IPv4) (Figure 13).

Figure 13 Local Area Connection Properties dialog box – Internet Protocol Version 4

The Internet Protocol Version 4 (TCP/IPv4) Properties dialog box opens.

e On the General tab of the dialog box, select Use the following IP address and set the IP

address, subnet mask, and default gateway to the values shown in Figure 14. Click OK to close the dialog box.

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Figure 14 Internet Protocol Version 4 dialog box – Use the following IP address

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Setting Up the AriaDx Instrument

Step 1. Turn on the instrument and calibrate the background for the optical modules

1 Press the power button located near the bottom left corner on the front of the instrument.

The instrument performs a series of health checks to ensure basic hardware functionality. If the health checks reveal an instrument error, record the error and then perform a more detailed diagnostic check (see “Step 3. Run a diagnostic check” on page 24). The instrument performs the health checks each time it is powered on. When the tests are complete, the instrument touchscreen opens to the Home screen.

Anytime you install new optical modules, a message box opens prompting you to calibrate the background for the optical modules.

2 Press OK in the message box.

The Background Calibration screen opens.

3 Press Calibrate.

A message box opens instructing you to load a 96-well QPCR plate containing 20 l of deionized H20 or TE buffer in each well onto the thermal block.

4 Prepare the plate and load it into the thermal block. Close the instrument door and press OK in

the message box. See “Load samples” on page 53 for instructions on plate loading. See “Recommended

plasticware” on page 8 for ordering information on 96-well plates.

The instrument runs the calibration. At the end of calibration, a message box opens on the touchscreen notifying you that the calibration was successful.

5 Click OK in the message box to close it.

The touchscreen returns to the Home screen. You are logged in to the Guest account.

The color touchscreen on the AriaDx instrument allows you to operate the instrument by touching the buttons on the screen. If a mouse has been connected to the instrument, you may select buttons by clicking. When software functions require data input from a keyboard, the touchscreen automatically displays a virtual keyboard. You can also type in data input using a USB-connected keyboard.

Step 2. Set the instrument date and time

1 In the bottom right corner of the touchscreen, press the time and date this is currently

displayed.

2 In the menu that opens, press Change Date & Time.

The Date & Time Settings screen opens.

3 Use the fields to set the date and time to the correct values. Press the help icon for detailed

instructions on setting the date and time on this screen.

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Step 3. Run a diagnostic check

1 On the Home screen of the touchscreen, press Settings.

2 Press Instrument Diagnostic.

3 Press Run Diagnostics.

4 Mark the check box at the top of the screen labeled All Test.

5 Press Run.

A message box opens prompting you to make sure that no plate is loaded on the thermal block.

6 Press OK to continue.

A dialog box opens displaying a schematic of the optical modules installed in the housing.

7 Mark the check boxes for all slots in the housing that contain an optical module. For empty

slots, leave the check box clear. Press OK. The instrument begins running the diagnostic check. The first set of tests is the user

interaction tests.

8 During the user interaction tests, perform all actions and answer questions as prompted on the

touchscreen. After the user interaction tests, the instrument runs the diagnostic tests. No user input is

required during this set of tests. At the end of the diagnostic check, the touchscreen opens to the Diagnostic Report screen.

Figure 15 Diagnostic report banner, with the test results circled in red

9 Check the diagnostic report. The banner at the top of the report lists the number of tests that

passed out of the total number of test performed (see Figure 15).

• If all tests passed, you can close the diagnostic report.

• If any of the tests failed, contact Agilent Technical Support. See page 12 for contact

information.

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Logging In and Creating User Accounts

The AriaDx instrument offers individualized user accounts, allowing each AriaDx user to log in to the instrument with their own account and save experiments to their own user folder. Three different access levels are available for user accounts: Administrator, User, and Guest. Each level has specific user rights as described in Table 6.

Table 6 Access levels

Access Level Functions allowed

Guest • Access rights to the Guest folder

User • Access rights to the Guest and personal user folder

Administrator • Access rights to the Guest folder and all user folders

• Creation and management of user accounts

• Installation of instrument software updates

• Access rights to the instrument diagnostic reports

Each time you turn on the instrument, you are automatically logged in to the Guest account. Use of the Guest account is not recommended for organizations that prioritize file security.

Step 1. Log in to the instrument using an Administrator account

1 From the Home screen of the touchscreen, press User Login. Alternatively, from any screen of

the touchscreen, press Current User at the bottom of the screen, then press Open Login Page. The User Login screen opens.

2 In the User Name drop-down, select the user name for an account that has Administrator

access level. The instrument comes preloaded with a default Administrator account that you can select

here.

3 In the Password field, type the password for the account.

The default password for the Administrator user name is ADMIN.

4 Press Login.

A message box opens confirming that you logged in to the instrument. Press OK to close the message box.

5 (Optional) Change the default password for the Administrator account.

a From the Home screen, press Settings.

b Press User Management.

c On the User Management screen, select the Administrator account and press Edit.

d In the Password and Confirm Password fields, type a new password for the account.

e Press OK to save the new password.

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Step 2. Add user accounts

1 From the Home screen, press Settings.

2 Press User Management.

The User Management screen opens listing the available user names and corresponding access levels.

3 Press Add.

The Add User screen opens.

Figure 16 Add User screen

4 In the User Name field, type a user name.

5 In the Access Level drop-down list, select an access level for the account. The options are

Administrator and User.

See Table 6 on page 25 for a description of access levels.

6 In the Password and Confirm Password fields, type a password for the account.

7 Press OK to save the account.

A message box opens confirming the creation of the new account. Click OK to close the message box. You are returned to the User Management screen.

8 Repeat step 3 through step 7 for any additional user accounts that you want to create.

Step 3. Log in to your personal user account

Logging in to your personal account allows you to access your user folder. If you are logged in as Guest, you must save the experiment to the Guest folder.

1 From the Home screen of the touchscreen, press User Login. Alternatively, from any screen of

the touchscreen, press Current User at the bottom of the screen, then press Open Login Page. The User Login screen opens.

2 In the User Name drop-down, select your user name. In the Password field, type the password

for the account.

3 Press Login.

A message box opens confirming that you logged in to the instrument. Press OK to close the message box.

To log out, press Current User at the bottom of any screen, then press Log Out.

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Customizing Instrument Settings

You can access a variety of instrument settings using the buttons on the Settings screen of the touchscreen. Each button takes you to a different screen in the touchscreen software. From each screen, press the Help icon for more information on the settings available.

Table 7 Buttons on the Settings screen

Button Description

User Management – Opens the User Management screen, which has tools for

creating and managing user accounts. This screen can only be accessed when an Administrator user is logged in to the instrument.

System Settings – Opens the System Settings screen, which has tools for accessing and managing instrument settings including date/time, optical module information, PC connections, experiment resumption, instrument name and calibration processes.

Software Updates – Displays software version information for the instrument. An Administrator user can use this screen to update the AriaDx instrument software.

Hot Top Settings – Use this button to enable or disable the instrument hot top.

Connection Settings – Displays the IP address and other network information for the

instrument.

Instrument Diagnostic – Opens the Diagnostic Test screen, which contains buttons for running instrument troubleshooting tests and viewing and reporting the results. See “Open the diagnostic report” on page 69.

Calibrate Touch – Use this button to calibrate the touchscreen. The calibration screen instructs you to touch a marker (+) appearing on the screen in order to calibrate the touchscreen response functions.

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AriaDx Real-Time PCR System Setup and User Guide

3 Installing the Aria Software

Minimum requirements for running the Aria software 2 Installing the Standard Aria Software 3

Download the Aria software 3 Install the standard Aria software 3 Launch the Aria software 7

Installing the Aria ET (Electronic Tracking) Software 8

Download the Aria software and Microsoft SQL Server 2012 8 Install Microsoft SQL Server 2012 8 Install the Aria ET software 12 Configure and start Microsoft Distributed Transaction Coordinator (MSDTC) service 17 Launch the Aria ET software 20

Install Microsoft .NET Framework 4.0 22

Download Microsoft .NET Framework 4.0 22 Install Microsoft .NET Framework 4.0 22

This chapter contains installation instructions for installing the Aria software on your PC.

Minimum requirements for running the Aria software

Before installing the Aria software, see Table 1 for the minimum PC requirements needed to run the software.

Table 1 Minimum requirements for running the Aria software

Operating system Windows 10 – with regional format set to English (United States)

Supported architectures ×64 (64 bit) supported on Windows 10

Programs* Microsoft .NET Framework 4.0

Microsoft SQL Server 2012 (required for ET software only) Runtime components of Microsoft Visual C++ 2010 Libraries

Processor 2 GHz Dual Core Processor

Working memory (RAM) 2 GB (more is recommended)

Hard disk space 40 GB

Display resolution 1024 × 768 (1280 × 1024 is recommended)

* Installers for Microsoft .NET Framework 4.0 and Microsoft SQL Server 2012 are provided on the

AriaDx Software Download page of the Agilent website (see “Install Microsoft SQL Server

2012” on page 8 and “Installing Microsoft .NET Framework 4.0” on page 22). If you do not have

the needed Microsoft Visual C++ 2010 components, then the Aria installer will automatically install them to your PC when you initiate installation of the Aria software.

AriaDx Real-Time PCR System Setup and User Guide 2

Installing the Standard Aria Software

NOTE

If you connected your instrument directly to a PC, install the software on that PC. If you connected your instrument to a network, install the software on a network PC. You can install the standard Aria software on an unlimited number of PCs.

Make sure your PC meets the minimum requirements needed to run the Aria software. See

Table 1 on page 2 for a list of the minimum requirements.

The instructions in this chapter are for the installation of the standard Aria software. If you purchased the optional 21 CFR Part 11-compatible features – which include user authentication, database data storage, and audit trail support – use the instructions in“Installing the Aria ET (Electronic Tracking) Software” on page 8.

Download the Aria software

To download the installer for the Aria software:

1 Go to the AriaDx Software Download website at

www.agilent.com/en/product/real-time-pcr-(qpcr)/real-time-pcr-(qpcr)-software/ariadx-sof tware-download.

2 Under Aria Software Download, click the link for the latest version of the software.

The software request page opens in a new tab or window of your internet browser.

3 Complete the fields on the page and click Submit.

The page updates to provide a link for downloading the firmware software and a link for downloading the Aria software.

4 Click the link to download the Aria software.

5 Save the Installer to your computer. The Installer is named Agilent Aria Software Setup X.X.exe

(where X.X is the software version).

Install the standard Aria software

To install the Aria software:

1 Double-click the file called Agilent Aria Software Setup X.X.exe (where X.X is the version number

of the software). The Aria software installation wizard starts. Following the file extraction process, the wizard

opens to the Welcome window.

NOTE

AriaDx Real-Time PCR System Setup and User Guide 3

If you receive an error message stating that Microsoft .NET Framework 4.0 needs to be installed, cancel the installation of the Aria software and install Microsoft .NET Framework 4.0 first. See “Installing the Standard Aria Software” on page 3.

Figure 1 Agilent Aria installation wizard – Welcome window

2 Click Next to continue with the installation.

The License Agreement window opens.

Figure 2 Agilent Aria installation wizard – License Agreement window

3 If you accept the terms of this agreement, select I agree to the terms in the license agreement

and click Next. (If desired, click Print before clicking Next to print a copy of the license agreement.)

The Application Mode window opens.

AriaDx Real-Time PCR System Setup and User Guide 4

Figure 3 Agilent Aria installation wizard – Application Mode window

4 In the Application Mode window, select AriaDx, then click Next.

The Setup Type window opens.

NOTE

The AriaDx mode of the software is only compatible with the AriaDx instrument. The AriaMx mode of the software is only compatible with the AriaMx instrument.

Figure 4 Agilent Aria installation wizard – Setup Type window

5 In the Setup Type window, Standard is selected by default. Leave this selection in place and

click Next. The Destination Folder window opens.

AriaDx Real-Time PCR System Setup and User Guide 5

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Figure 5 Agilent Aria installation wizard – Destination Folder window

6 Designate a folder for the software files. The default folder is

C:\Program Files (x86)\Agilent\Agilent Aria.

• If you want to install the software to the default folder, click Next to continue.

• If you want to designate a different folder, click Change in the Destination Folder window. In

the dialog box that opens, browse to the desired folder, select the folder, and click Open. Then, in the Destination Folder window, click Next to continue.

The Ready to Install window opens.

Figure 6 Agilent Aria installation wizard – Ready to Install window

7 Click Install.

AriaDx Real-Time PCR System Setup and User Guide 6

The wizard installs the Aria software to the folder designated in step 10. When installation is complete, the InstallShield Wizard Completed window opens.

Figure 7 Agilent Aria installation wizard – InstallShield Wizard Completed window

8 Click Finish to close the wizard.

Launch the Aria software

After installation is complete, the software is ready to launch.

To launch the Aria software:

1 From the Start menu, click All Programs > Agilent > Agilent Aria > Agilent Aria X.X (where X.X

is the version number of the software). The software opens to the Getting Started screen.

NOTE

During installation, a set of sample experiments (*.adxd) and sample templates (*.adxt) were saved to the following folders.

C:\Users\Public\Public Documents\Agilent Aria\Sample Experiments C:\Users\Public\Public Documents\Agilent Aria\Experiment Templates

You can now open these files in the Aria software.

AriaDx Real-Time PCR System Setup and User Guide 7

Installing the Aria ET (Electronic Tracking) Software

Make sure your PC meets the minimum requirements needed to run the Aria software. See

Table 1 on page 2 for a list of the minimum requirements.

Download the Aria software and Microsoft SQL Server 2012

To download the installers for the Aria software and the Microsoft SQL Server 2012 software:

1 Go to the AriaDx Software Download website at

www.agilent.com/en/product/real-time-pcr-(qpcr)/real-time-pcr-(qpcr)-software/ariadx-sof tware-download.

2 Under Aria PC Software requirements, click Server set up software for Electronic Tracking

software upgrade.

3 Save the Installer to your computer. The Installer is named

Agilent.Aria.SQLServer2012Setup.exe.

4 Under Aria Software Download, click the link for the latest version of the software.

The software request page opens in a new tab or window of your internet browser.

5 Complete the fields on the page and click Submit.

The page updates to provide a link for downloading the firmware software and a link for downloading the Aria software.

6 Click the link to download the Aria software.

7 Save the Installer to your computer. The Installer is named Agilent Aria Software Setup X.X.exe

(where X.X is the software version).

Install Microsoft SQL Server 2012

Install Microsoft SQL Server 2012 prior to installing the Aria ET software. The Aria ET software uses SQL Server for storage of the databases.

NOTE

To install Microsoft SQL Server 2012:

1 Double-click the file called Agilent.Aria.SQLServer2012Setup.exe.

The Aria SQL Server installation wizard opens.

AriaDx Real-Time PCR System Setup and User Guide 8

You can install SQL Server on a different PC than the Aria ET software provided that the two PCs are on the same network domain. Importantly, the Aria ET PC and the SQL Server PC need to be joined to the same domain prior to installation of the Aria ET software. Your network administrator can help you join the PCs to the same domain.

The database system used by Aria ET (Microsoft SQL Server 2012) is known to be incompatible with Microsoft Server Desktop Engine. For this reason, install SQL Server on a PC that is not already running Microsoft Server Desktop Engine.

Figure 8 Aria Microsoft SQL Server 2012 installation wizard

2 Click Next to continue.

The License Agreement window opens.

Figure 9 Aria Microsoft SQL Server 2012 installation wizard – License Agreement window

3 If you accept the terms of this agreement, select I accept the terms in the license agreement

and click Next. (If desired, click Print before clicking Next to print a copy of the license agreement.)

The Instance Configuration window opens.

AriaDx Real-Time PCR System Setup and User Guide 9

Figure 10 Aria Microsoft SQL Server 2012 installation wizard – Instance Configuration window

4 In the Instance Name field of the Instance Configuration window, type a name for the server

instance you want to install. Hover your cursor over the Information icon next to the field to see guidelines on selecting a valid instance name.

5 In the Enter Password field, type a password for the server instance. Hover your cursor over

the Information icon next to the field to see guidelines on selecting a valid password. Type the password again in the Confirm Password field.

6 Click Next in the Instance Configuration window.

The Ready to Install window opens.

Figure 11 Aria Microsoft SQL Server 2012 installation wizard – Ready to Install window

AriaDx Real-Time PCR System Setup and User Guide 10

7 Click Install.

The Installing window opens and remains open until installation is complete.

Figure 12 Aria Microsoft SQL Server 2012 installation wizard – Installing window

When installation is complete, the SQL Server 2012 Installation Completed window opens.

Figure 13 Aria Microsoft SQL Server 2012 installation wizard – SQL Server 2012 Installation

Completed window

8 Click Finish to close the wizard.

AriaDx Real-Time PCR System Setup and User Guide 11

Install the Aria ET software

To install the Aria ET software:

1 Double-click the file called Agilent Aria Software Setup X.X.exe (where X.X is the version number

of the software). The Aria software installation wizard starts. Following the file extraction process, the wizard

opens to the Welcome window.

NOTE

Figure 14 Agilent Aria installation wizard – Welcome window

1 Click Next to continue with the installation.

The License Agreement window opens.

AriaDx Real-Time PCR System Setup and User Guide 12

Figure 15 Agilent Aria installation wizard – License Agreement window

2 If you accept the terms of this agreement, select I agree to the terms in the license agreement

and click Next. (If desired, click Print before clicking Next to print a copy of the license agreement.)

The Application Mode window opens.

Figure 16 Agilent Aria installation wizard – Application Mode window

3 In the Application Mode window, select AriaDx, then click Next.

The Setup Type window opens.

NOTE

AriaDx Real-Time PCR System Setup and User Guide 13

The AriaDx mode of the software is only compatible with the AriaDx instrument. The AriaMx mode of the software is only compatible with the AriaMx instrument.

Figure 17 Agilent Aria installation wizard – Setup Type window

4 In the Setup Type window, select Electronic Tracking. Click Next.

The Software Activation window opens.

Figure 18 Agilent Aria installation wizard – Software Activation window

5 The Software Activation window displays the Licensing Host ID. Follow the instructions

provided on your Software Entitlement Certificate to use this Licensing Host ID to redeem your software license and save the file to your PC. Then, in the Software Activation window, click Browse to open a dialog box where you can browse to the folder containing the license file. Select the file and click Open.

The dialog box closes and you are returned to the Software Activation window.

6 Click Next.

AriaDx Real-Time PCR System Setup and User Guide 14

The Database Server window opens.

Figure 19 Agilent Aria installation wizard – Database Server window

7 In the drop-down list at the top of the Database Server window, select the database server

instance that you set up while installing SQL Server (see step 4 on page 10).

8 In the Password field, type the password for the database server instance that you entered

while installing SQL Server (see step 5 on page 10).

9 Select a database to use as the primary database when you log in to the Aria ET software.

• To create a new database, select Create new database. Type a name for the database into

the adjacent field or use the default database name.

• To select an existing database, select Select existing database. Click Browse, and in the

dialog box that opens, select the database that you want to use and click OK. The dialog

box closes. After you make your selection, click Next in the Database Server window. The Destination Folder window opens.

AriaDx Real-Time PCR System Setup and User Guide 15

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Figure 20 Agilent Aria installation wizard – Destination Folder window

10 Designate a folder for the software files. The default folder is

C:\Program Files (x86)\Agilent\Agilent Aria.

• If you want to install the software to the default folder, click Next to continue.

• If you want to designate a different folder, click Change in the Destination Folder window. In

the dialog box that opens, browse to the desired folder, select the folder, and click Open.

Then, in the Destination Folder window, click Next to continue. The Ready to Install window opens.

Figure 21 Agilent Aria installation wizard – Ready to Install window

11 Click Install.

AriaDx Real-Time PCR System Setup and User Guide 16

The wizard installs the Aria software to the folder designated in step 10. When installation is complete, the InstallShield Wizard Completed window opens.

Figure 22 Agilent Aria installation wizard – InstallShield Wizard Completed window

12 Click Finish to close the wizard.

Configure and start Microsoft Distributed Transaction Coordinator (MSDTC) service

In order to archive and restore experiments to and from a database in the Aria ET software, your PC must be running MSDTC service.

Start MSDTC service

To start MSDTC service:

1 Open the Control Panel on your PC. Make sure you are viewing the Control Panel by category.

2 Click System and Security, then click Administrative Tools.

The Administrative Tools folder opens in Windows Explorer.

3 Double-click Services.

The Services window opens.

4 In the Name column of the Services window, double-click Distributed Transaction

Coordinator.

The Distributed Transaction Coordinator Properties dialog box opens.

5 Click the Log On tab of the Distributed Transaction Coordinator Properties dialog box. Make

sure that This account is selected and that the adjacent field reads “Network Service.”

AriaDx Real-Time PCR System Setup and User Guide 17

Figure 23 Distributed Transaction Coordinator Properties dialog box – Log On tab

6 On the General tab of the Distributed Transaction Coordinator Properties dialog box, set the

Startup type to Automatic, then click Start.

AriaDx Real-Time PCR System Setup and User Guide 18

Figure 24 Distributed Transaction Coordinator Properties dialog box – General tab

7 Click OK to close the Distributed Transaction Coordinator Properties dialog box.

Configure Network Distributed Transaction Coordinator (DTC) access

1 Open the Windows Start menu and click Run.

The Run dialog box opens.

2 In the Open field, type dcomcnfg.exe and click OK.

The Component Services window opens.

3 In panel on the left side of the Component Services window, expand Component Services >

Computers > My Computer > Distributed Transaction Coordinator.

4 Right-click on Local DTC. In the pop-up menu click Properties.

The Local DTC Properties dialog box opens.

5 Click the Security tab. Under Security Settings mark Network DTC Access.

6 Under Transaction Manager Communication mark Allow Inbound and Allow Outbound, and

select No Authentication Required.

AriaDx Real-Time PCR System Setup and User Guide 19

Figure 25 Local DTC Properties dialog box – Security tab

7 Click OK.

The Local DTC Properties dialog box closes and the MSDTC service starts or restarts.

8 Close the Component Services window.

Launch the Aria ET software

After installation is complete, the software is ready to launch.

To launch the Aria software:

1 From the Start menu, click All Programs > Agilent > Agilent Aria > Agilent Aria X.X (where X.X

is the version number of the software). The Login dialog box opens, prompting you to log in to the primary database that you set up

during installation the Aria ET software (see step 9 on page 15).

2 Log in using the default administrator account.

a In the Username field, type admin.

b In the Password field, type Password.

c Click Login or press Enter.

The Change Password dialog box opens.

3 Select a new password for the account.

a In the Old Password field, type Password.

AriaDx Real-Time PCR System Setup and User Guide 20

b In the New Password field, type a new password of your choosing. The password must be

6–15 characters in length and include at least one number.

c Retype the new password into the Confirm Password field.

d Click OK.

The dialog box closes. The software opens to the Getting Started screen.

NOTE

During installation, a set of sample experiments and sample templates were saved to the following folders.

C:\Users\Public\Public Documents\Agilent Aria\Sample Experiments C:\Users\Public\Public Documents\Agilent Aria\Experiment Templates

You can now open these files in the Aria software.

AriaDx Real-Time PCR System Setup and User Guide 21

Installing Microsoft .NET Framework 4.0

In order to install the Aria software, you must have Microsoft .NET Framework 4.0 or greater installed on your PC. If you attempted to install the Aria software and received an error message stating that Microsoft .NET Framework 4.0 is needed, follow the instructions in this section to install this software.

Download Microsoft .NET Framework 4.0

To download the installer for the Aria software:

1 Go to the AriaDx Software Download website at

www.agilent.com/en/product/real-time-pcr-(qpcr)/real-time-pcr-(qpcr)-software/ariadx-sof tware-download.

2 Under Aria PC Software requirements, click Microsoft .NET Framework 4.0 Installer.

3 Save the Installer to your computer. The Installer is named dotnetfx40_full_x86_x64.exe.

Install Microsoft .NET Framework 4.0

1 Make sure your PC is connected to the internet.

2 Double-click the dotNetFx40_Full_setup.exe file.

The Microsoft .NET Framework 4 Setup window opens, displaying the software license.

AriaDx Real-Time PCR System Setup and User Guide 22

Figure 26 Microsoft .NET FrameWork 4 Setup – License window

3 If you accept the terms of this agreement, select I have read and accept the license terms and

click Install. (If desired, click the Print icon or Save icon before clicking Install to print or save a copy of the license agreement.)

The installer installs Microsoft .NET FrameWork 4.0. During installation, the Microsoft .NET FrameWork 4 Setup window remains open and displays progress bars for the installation tasks. When installation is complete, the Installation Is Complete window opens.

AriaDx Real-Time PCR System Setup and User Guide 23

Figure 27 Microsoft .NET FrameWork 4 Setup – Installation Is Complete window

4 Click Finish to close the Microsoft .NET FrameWork 4 Setup window.

AriaDx Real-Time PCR System Setup and User Guide 24

AriaDx Real-Time PCR System Setup and User Guide

4 Running Experiments

Preparing and Loading PCR Samples 53 Prepare samples 53 Load samples 53 Setting Up and Running Experiments 54 Use the touchscreen to set up and run an experiment 54 Use the PC software to set up and run an experiment 54 Managing Saved Experiments 56 Locate saved experiment files 56 Create a subfolder 56 Copy and paste experiments 57 Transfer experiments to a USB drive 57

This chapter contains instructions on preparing and running experiments and managing experiment files on the instrument.

Preparing and Loading PCR Samples

Prepare samples

When preparing the PCR reactions, follow the guidelines below for optimal results.

• Use only temperature-stable PCR tubes and plates. See “Recommended plasticware” on page 8 for a list of recommended tubes and plates.

• Place caps on tubes before loading samples into the thermal block.

• Spin samples briefly in a centrifuge immediately before loading them into the thermal block.

Load samples

The instrument can be loaded with individual PCR tubes or strip tubes or one 96-well PCR plate.

1 Open the instrument door that covers the thermal block assembly by lifting up on the handle

on the top of the instrument. Lift the door all the way up and back.

2 Lift the heated lid by pulling forward on the handle of the lid and then lifting the lid up and away

from the thermal block.

3 Put your plate or tubes on the block and check that they are correctly positioned.

4 Close the heated lid and push it backwards so that it latches into place.

5 Close the instrument door so that it latches into place.

WARNING

Danger of Burns: The thermal block, sample tubes and plates may reach temperatures as high as 100°C. Keep hands away until temperature is 30°C or less.

AriaDx Real-Time PCR System Setup and User Guide 53

Setting Up and Running Experiments

You can set up the plate and thermal profile for an experiment on either the instrument touchscreen software or on the Aria software on your PC. The instructions below provide the basic steps required to set up an experiment and start running the experiment. For more detailed information about setting up and running experiments, see the help system in the Aria PC software.

Use the touchscreen to set up and run an experiment

1 (Optional) Log in the instrument. See “Step 3. Log in to your personal user account” on page 26.

Logging in to your personal account allows you to save the experiment to your user folder. If you are logged in as Guest, you must save the experiment to the Guest folder.

2 On the Home screen, press New Experiment.

The Experiment Types screen opens.

3 Create the experiment using one of the following approaches.

• Press the desired experiment type.

The Plate Setup screen opens.

• Press Open Template. The Template screen opens. Press a template file to select it then

press Open. (The only template files listed are those that were previously saved to the instrument.) The Plate Setup screen opens.

4 On the Plate Setup screen, set up the wells of the plate. Press the help icon for help with

working on the Plate Setup screen.

5 Press the Thermal Profile tab.

The Thermal Profile screen opens.

6 Set up the thermal profile for the experiment. Press the help icon for help with working on the

Thermal Profile screen.

7 Load the samples onto the thermal block (see “Load samples” on page 53), and press Run

Experiment on the Thermal Profile screen.

A message box opens asking you to save the experiment. Click OK to open the Save Experiment screen.

8 Select a folder for the experiment file and press Save.

The Raw Data Plots screen opens, allowing you to monitor the progress of the run.

Use the PC software to set up and run an experiment

1 On the Getting Started screen, create the experiment using one of the following approaches.

• Click Experiment Types. The screen displays the experiment types. Click the desired

experiment type to select it. Type a name for the experiment and click Create. The Plate Setup screen opens.

AriaDx Real-Time PCR System Setup and User Guide 54

• Click My Templates. The screen displays the templates in the default template folder. Click

the desired template to select it. Type a name for the experiment and click Create. The Plate Setup screen opens.

• Click From LIMS file. The screen displays a wizard for importing a LIMS data file. Use the

wizard to import a saved LIMS data file and describe the new experiment. Upon completing the wizard, the Plate Setup screen opens.

2 On the Plate Setup screen, set up the wells of the plate. See the software help system for help

with setting up the plate.

3 Click Thermal Profile in the Experiment Area on the left side of the screen.

The Thermal Profile screen opens.

4 Set up the thermal profile for the experiment. See the software help system for help with

setting up the thermal profile.

5 Click Run.

The Instrument Explorer dialog box opens.

6 In the dialog box, locate the instrument and click Send Config.

• If you have not already logged in to the selected instrument, you will be prompted to log in

before continuing.

• If you have not already saved the experiment you will be prompted to save it before

continuing.

7 Load your samples onto the thermal block (see “Load samples” on page 53).

8 At the bottom of the instrument touchscreen, press the icon shown below.

In the pop-up menu that opens, press Open Primed Experiment. The experiment opens on the touchscreen.

9 On the Thermal Profile screen of the touchscreen, press Run Experiment.

The Raw Data Plots screen opens, allowing you to monitor the progress of the run.

AriaDx Real-Time PCR System Setup and User Guide 55

Managing Saved Experiments

Each user account, including the Guest account, has its own user folder on the AriaDx instrument. Users can save and retrieve experiment files to and from the folders to which they have access. (All users have access to the Guest folder and the folder for their account. Administrator accounts have access to all folders on the instrument. Users logged in as Guest can only access the Guest folder and the HRM Calibration folder.)

Locate saved experiment files

1 If necessary, log in the instrument. See “Step 3. Log in to your personal user account” on

page 26. Logging in to your personal account allows you to access experiment files in your user folder.

If you are logged in as Guest, you can only access experiment files in the Guest folder and the HRM Calibration folder (which only contains HRM calibration experiments).

2 On the Home screen of the touchscreen, press Saved Experiment.

The Experiment Explorer screen opens. The left side of the screen lists the folders to which you have access.

3 Press directly on a folder to select it.

The right side of the screen lists the experiment files and any subfolders in the selected folder. Experiment files have the file extension adxd.

4 To open a subfolder, double-press the subfolder on the right side of the screen.

The subfolder expands to display the experiment files and subfolders contained within.

Create a subfolder

1 On the Experiment Explorer screen, locate the folder in which you want to create a subfolder.

Press the folder to select it. See “Locate saved experiment files”, above, for instructions on opening and navigating the

Experiment Explorer screen.

2 Press New Folder.

The virtual keyboard appears.

3 In the New Folder Name field, type a name for the subfolder. Press Create Folder.

The new subfolder appears on the Saved Experiment screen.

AriaDx Real-Time PCR System Setup and User Guide 56

Copy and paste experiments

1 On the Experiment Explorer screen, locate the experiment that you want to copy. Press the

experiment to select it. See “Locate saved experiment files” on page 56 for instructions on opening and navigating the

Saved Experiment screen.

2 Press Copy.

3 Browse to the folder to which you want to paste the experiment file. Press the folder to select

it.

4 Press Paste.

The experiment file is pasted to the selected folder.

Transfer experiments to a USB drive

1 Insert a FAT format USB drive into the USB port on the front of the instrument.

2 On the Experiment Explorer screen, locate the experiment that you want to copy. Press the

experiment to select it. See “Locate saved experiment files” on page 56 for instructions on opening and navigating the

Saved Experiment screen.

3 Press Copy.

4 On the left side of the Experiment Explorer screen, press the folder for the USB drive (called

USBDisk).

5 Press Paste.

A copy of the experiment file is saved to the USB drive.

NOTE

You can also transfer experiments from the instrument to the Aria PC software by connecting the instrument directly to the PC or a network. See page 20 for instructions setting up PC or network connections. See the help system for the Aria PC software for instructions on retrieving experiments from a connected instrument.

AriaDx Real-Time PCR System Setup and User Guide 57

AriaDx Real-Time PCR System Setup and User Guide

5 Calibrating the AriaDx System

Calibrating the Instrument Motor 59 Calibrate the motor 59 Check the motor calibration date 59 Calibrating the Background 60 Calibrate the background 60 Check the background calibration status 60 Performing Other Calibration Procedures 61 Calibrate the touchscreen 61 Calibrate the analysis of high resolution melt data 61

This chapter contains instructions for calibration procedures that can be performed on the AriaDx Real-Time PCR System.

Calibrating the Instrument Motor

Motor calibration is performed prior to shipping a new instrument, and you do not need to calibrate it again unless the instrument prompts you to do so.

Calibrate the motor

Instruments are provided with the motor calibration step completed, and additional motor calibration runs are not generally required after receipt of the instrument. If, however, you see a notification on the instrument touchscreen alerting you that motor calibration is required, press

Calibrate, then follow the on-screen prompts.

NOTE

Changing the installed optical modules does not affect the motor calibration.

Check the motor calibration date

You can check the date and time of the most recent motor calibration run.

1 On the Home screen, press Settings.

2 On the Settings screen, press System Settings.

3 On the System Settings screen, press Motor Calibration.

This screen displays the date and time that motor calibration was run for the instrument.

AriaDx Real-Time PCR System Setup and User Guide 59

Calibrating the Background

Background calibration determines the level of background noise associated with each optical module and compensates for that background. Anytime you install new optical modules, a message box opens on the touchscreen prompting you to calibrate the background for the optical modules.

Calibrate the background

When replacing the optical module installed in any slot with a different module, the touchscreen will prompt you to run the Background Calibration for the newly-installed module.

1 When a message box opens on the touchscreen prompting you to run background calibration,

press Calibrate. The Background Calibration screen opens.

2 Prepare the PCR plate for the calibration run.

a Add 20 l of water or TE buffer (10 mM Tris/1 mM EDTA) into all 96 wells of a PCR plate.

Cap the wells or seal with film.

b Spin the plate briefly to collect the fluid at the bottom of the wells.

c Insert the plate in the thermal block, close the hot top, and press Calibrate on the

touchscreen.

When the instrument has completed the calibration, the Background Calibration screen will be updated to show the revised calibration status for each optical module.

3 Press Cancel to return to the System Settings screen.

Check the background calibration status

You can check the date and time of the most recent background calibration run for each optical module that is currently installed.

1 On the Home screen, press Settings.

2 On the Settings screen, press System Settings.

3 On the System Settings screen, press Background Calibration.

This screen displays the background calibration status and other properties of the optical module installed in each slot of the instrument. To view the properties of a specific installed optical module, press the bar corresponding to that module slot on the left side of the screen.

AriaDx Real-Time PCR System Setup and User Guide 60

Performing Other Calibration Procedures

The other calibration procedures available on the AriaDx system include calibrating the touchscreen and

Calibrate the touchscreen

You can calibrate the touchscreen response functions in order to optimize sensitivity.

1 On the Home screen, press Settings.

2 On the Settings screen, press Calibrate Touch.

The next screen instructs you to touch a marker (+). Follow the prompts provided on the screen.

Calibrate the analysis of high resolution melt data

For experiments that include a high resolution melt (HRM) segment, you must associate the experiment with an HRM calibration plate (HCP) that was run on the same instrument. See the help system for the Aria software for instructions on running an HCP.

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AriaDx Real-Time PCR System Setup and User Guide

6 Maintaining, Updating, and Disposing of the AriaDx

System

Maintaining the Instrument 63 Service the instrument 63 Clean the instrument 63 Clean the optical modules 63 Updating the Instrument Software 65 Disposing of Instrument Parts 66 Cybersecurity Guidance 67

This chapter contains instructions for maintaining the instrument, uploading software updates, and disposing of instrument parts.

Maintaining the Instrument

The AriaDx instrument is designed to require a minimum amount of maintenance by the user.

Service the instrument

As preventative maintenance, Agilent recommends having your AriaDx instrument serviced by an Agilent service engineer every 12 months. Contact Agilent technical support for information on instrument service. See “Agilent Technical Support” on page 12 for contact information.

Clean the instrument

To clean the exterior of the AriaDx instrument:

1 Turn off and disconnect the instrument from the power supply.

2 Using laboratory wipes moistened with 70% isopropyl alcohol, clean the exterior surfaces of

the instrument listed below. Do not let liquid enter the instrument.

• All surfaces of the door including the depression at the top that is used to open the door

• The surface of the touchscreen

• Both sides of the instrument

• The power button and adjacent area

• The front panels of the instrument

• Allow isopropyl alcohol to evaporate before reconnecting the instrument to the power supply.

Clean the optical modules

To clean an optical module:

1 Remove the optical module from its slot in the optical module housing.

a Open the lid on the optical module housing carrier.

b Lift the hinged tab on the top of the optical module (see Figure ), then use the tab to lift the

optical module out of its slot.

AriaDx Real-Time PCR System Setup and User Guide 63

Figure 44 Lifting the hinged tab on an optical module

2 Using an aerosol can of compressed air, clean the bottom surface of the optical module (the

surface opposite of the label). Hold the can 3–4 inches away from the surface as you press the trigger.

3 (Optional) Wipe the bottom surface with a lens cloth or lens tissue moistened with

reagent-grade isopropyl alcohol or reagent-grade acetone.

4 Re-install the optical module into the housing. Lower the hinged tab until it snaps into place.

5 Close the lid on the housing carrier.

AriaDx Real-Time PCR System Setup and User Guide 64

Updating the Instrument Software

You will be notified by Agilent when a new version of the instrument software is available. This notification includes a web address where you can download the software files. Save these files to a USB memory stick and then upload them to your instrument using the instructions below.

1 Login to one of the Administrator user accounts. See “Step 1. Log in to the instrument using an

Administrator account” on page 25.

2 From the Home screen, press Settings and then press Software Update.

3 Insert the USB memory stick into the USB port on the front of the instrument.

4 Press Browse to open a browser that allows you to navigate to the folder containing the

software files. Select the appropriate folder and press OK to return to the Software Update screen.

5 Press Update.

The instrument begins the update. When the update is complete, the instrument automatically reboots.

6 When the reboot is complete, you may return to the Software Update screen to confirm the

new version of the software is running.

AriaDx Real-Time PCR System Setup and User Guide 65

Disposing of Instrument Parts

If, at any time, the AriaDx instrument or any of its parts, including the optical modules, are no longer of use, you can return the unneeded items to Agilent as part of the Agilent Product Take-Back program. See http://www.agilent.com/environment/product/index.shtml for information on this program.

AriaDx Real-Time PCR System Setup and User Guide 66

Cybersecurity Guidance

The Electronic Tracking (ET) option for the Aria software provides the ability for user account management, including creating, changing, safeguarding, and terminating accounts. The HealthCare Organization shall create corresponding internal procedures to address the following items:

1 All the network equipment, computer hardware, software, databases etc. must be protected by

user authentication (ID and password).

2 System should be accessible though domain as well as local user.

3 System should use Windows and/or Hospital Information (IT) infrastructure password policy.

4 System should support role management access. Access to files and drives should be given

for appropriate role.

5 System should allow appropriate users to

• Create new users

• Add/remove privileges to user

• Terminate/disable user

• Create groups with defined privileges

• Add/remove users to/from group.

6 System should be locked after predefined time of inactivity.

7 All systems should have anti-virus and anti- spyware software installed.

8 The anti-virus and anti-spyware software should be updated regularly.

9 Important data should be secured using Cryptography or encryption- decryption equipment.

10 Data transmitted to and from devices must be encrypted.

11 Unauthorized devices trying to connect to the network must be blocked.

12 Unused ports should be blocked to minimize risk of tampering.

13 Firewall should be set to prevent unauthorized access from internet/intranet.

14 The use of mobile devices must follow mobile device management policy.

15 Documented procedures for addressing security breaches must beavailable.

16 Authorized user accounts must be regularly audited.

17 Database backup must be performed on a regular basis and must be performed before

installing any software upgrades.

18 Employees must be educated on privacy and security policies through a strict training process.

19 The number of remote computers, portable devices and ports used to connect to IVD systems

should be kept to a minimum.

20 Software must be kept up- to- date and any available patches promptly installed.

21 A documented security plan for disposal of unwanted data must be available.

22 Policies and processes for data security must be regularly reviewed and updated.

AriaDx Real-Time PCR System Setup and User Guide 67

AriaDx Real-Time PCR System Setup and User Guide

7 Troubleshooting

Troubleshooting Instrument Error Messages 69 View error messages 69 Open the diagnostic report 69

This chapter contains instructions for troubleshooting instrument errors.

Troubleshooting Instrument Error Messages

When the instrument detects issues with the hardware, firmware, or optical modules, it notifies you with an error message. Error messages are also prompted when the instrument encounters an issue while running the scanning application feature or while performing diagnostic tests.

View error messages

When the AriaDx instrument encounters an error, it notifies you by displaying an error icon at the bottom of the touchscreen.

1 Press the error icon at the bottom of the touchscreen.

2 In the pop-up menu that opens, press Count X, where X is the number of error messages to be

read. A table opens displaying the following information.

• Type - The type of message (Error or Warning). Warning messages are used for errors that

do not prevent you from running experiments on the instrument.

• ID - The error code ID number.

• Description - A description of the error with instructions on how to resolve it.

3 Press OK to close the table.

Open the diagnostic report

Some error messages may instruct you to refer to the diagnostics report for further details about the cause of an error.

1 Log in using an Administrator account.

See “Step 1. Log in to the instrument using an Administrator account” on page 25.

2 On the Home screen, press Settings.

The Settings screen opens.

3 Press Instrument Diagnostic.

The Diagnostic Test screen opens.

4 Press View Result.

The Diagnostic Report screen opens. The table lists each category of diagnostic test included on the report.

5 Double-press a category to expand its contents.

The table displays the tests within that category. The Results column indicates if the test passed or failed. The Run Date column lists the date and time of the test.

AriaDx Real-Time PCR System Setup and User Guide 69

www.agilent.com

Manufactured by

Agilent Technologies LDA Malaysia Sdn. Bhd. Bayan Lepas Free Industrial Zone 11900 Penang, Malaysia

Manufactured for Agilent Technologies Singapore (International) Pte. Ltd. No. 1 Yishun Ave 7, Singapore 768923

Authorized Representative for the European Union

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No part of this manual may be reproduced in any form or by any means (including electronic storage and retrieval or translation into a foreign language) without prior agreement and written consent from Agilent Technologies, Inc. as governed by United States and international copyright laws.

SYBR® is a registered trademark of Molecular Probes, Inc.

Version F0, March 2021

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