Module 5: GeneXpert Installation and Xpert MTB/RIF Set-up Global Laboratory Initiative – Xpert MTB/RIF Training Package Slides adapted from Cepheid

Module 5: GeneXpert Installation andXpert MTB/RIF Set-up

Global Laboratory Initiative – Xpert MTB/RIF Training Package

Slides adapted from Cepheid

Global Laboratory InitiativeXpert MTB/RIF Training Package-2-

How to unpack GeneXpert system components and place in laboratory

How to connect components

How to start up computer & software

How to create Admin and user accounts

How to import assay definition file How to issue “Installation Qualification Report” and its

importance

Contents of this moduleContents of this module


At the end of this module, you will be able to: Be familiar with the components of the GeneXpert

system and how to install it in your laboratory Learn how to use the software, create Admin and User

accounts, and import an Assay Definition File Understand the importance of the “Installation

Qualification Report”

Learning Objectives


Unpack the system and make sure items are complete

Keep the packaging and all the provided documents for future re-packaging/ expeditions

Instrument Package Contents

Computer Monitor, keypad, mouse GeneXpertBarcode reader


Place the GeneXpert on a hard, level surface

Provide at least 10 cm of clearance on each side of the GeneXpert

Do not block the fan exhaust on the lower back side or the air intake on the upper back side

Do not place GeneXpert in direct sun (i.e. in front of window)

Do not place GeneXpert directly under A/C unit

Ambient temperature in the room must be between 15-30°C

Make sure the power cord connection and the power switch (on the back side) are easily accessible

Installation of GeneXpert: Selection of Space

Picture: GeneXpert Users Manual, Cepheid


Connect one end of the supplied Ethernet cable to the network port on the back side of the computer

Connect the other end of the Ethernet cable to the network port on the lower back panel of the GeneXpert machine

NOTE: Ethernet cable is uni-directional. If it does not detect the GeneXpert machine, turn the cable around

Installation of GeneXpert: Connection


Connect the supplied power cords to the instrument, the computer and the monitor and then connect the power cords to a UPS (uninterruptable power supply).

Connect the barcode reader and the mouse directly to the computer USB ports.

Switch on the instrument: a small blue light on the front of the instrument turns on.

Installation of the barcode reader, mouse, UPS: connections Desktop computer

version is shown


Connect the supplied power cords to the instrument, the computer and the monitor and then connect the power cords to a UPS (uninterruptable power supply).

Connect the barcode reader and the mouse directly to the computer USB ports.

Switch on the instrument: a small blue light on the front of the instrument turns on.

Installation of the barcode reader, mouse, UPS: connections Laptop computer

version is shown


1. Switch on the GeneXpert: a small blue light will appear on the front panel

2. Switch on the computer3. Log on to Windows (XP or 7) as Cepheid

user to operate the system. To log on, use the following:

User name (Windows XP): Cepheid

User name (Windows 7): Cepheid-Amin

Password: cphd

Starting and configuring the Computer Software

Windows XP

Windows 7


4. Wait until the GeneXpert DX software starts automatically

5. In the Check Status screen, verify that all modules are “Available”

(If modules are not available, refer to chapter 11 of the Operator manual or call Cepheid technical support)


Windows XP

Windows 7


In case the software was closed (computer still on), the software may be restarted by clicking on the “GeneXpert Dx” icon on the desktop


Windows XP

Windows 7


1. Set up the local time in the Windows operation system2. Rename your GeneXpert in the software, from SETUP →

SYSTEM CONFIGURATION → replace “GeneXpert PC” by the laboratory name, country and serial number of the GeneXpert → see screenshot below and on next slide

Optimal installation: configuration of the software

Windows XP

Windows 7


Optimal installation: configuration of the software

Windows XP

Windows 7

3. Set up the options according to your needs (automatic printing, scanning a patient ID barcode, etc), from SETPUP → SYSTEM CONFIGURATION


1. ADMIN ACCOUNT: at first installation, before creating the User Account

2. USER ACCOUNT: enables staff to use the GeneXpert

3. ASSAY DEFINITION FILE (ADF): enables the device to run the XPERT MTB/RIF programme

4. INSTALLATION QUALIFICATION REPORT: report issued at the end of installation, to be signed and sent to Cepheid (necessary for machine calibration and warranty)

Installation of accounts and definition file


1. Click on “Setup/User administration”

Create Accounts: ADMIN

2. Click on “Add”

NOTE: The first account to be created must be an “Admin” account

Define the person in the lab that will have full access to the software. There can be more than one Administrator account per system.


3. Create user name & password:

(Ideally the same for all machines in the country)

Create Accounts: ADMIN (contd.)

4. Select User type: “Admin”

5. Click on “OK”


1. Click on “Setup/User administration”

Create Accounts: USER

2. Click on “Add”


NOTE: If you select “Detail”, the user will see the individual curves for the molecular beacons.

Create Accounts: USER (contd.)

3. Create user name & password:

(select yourself)

4. Select User type: “Basic”

5. Click on “OK”


How to login


Create a report at the end of installation:1) Click on “Reports”, and then on “Installation Qualification”2) A PDF file will come up: save this on computer and print a copy3) Supervisor signs the report and sends a copy to Cepheid:

[email protected]

Installation Qualification Report

IMPORTANT NOTE:The installation qualification report is required for machine calibration and warranty: it needs to be sent to Cepheid directly after installation.If not sent, the warranty date starts from the day of shipment (see Module 10 for more on warranties and maintenance).

mailto:[email protected]


In order to protect the GeneXpert software it is recommended to:

Install the antivirus software that is provided with the instrument (NortonTM)

Do not connect the computer to the internet, except when undergoing Xpert calibration or if connected to a remote data monitoring system

Do not use a USB key to transfer files to/from the computer. Use a CD or hard-disk to collect data

Virus protection


Upon reception, carefully check the package components, prior to installing the device in your laboratory

Connect the GeneXpert machine to all its components (PC, monitor, UPS, barcode scanner) and to internet (via Ethernet cable)

Create your "Admin" (at first installation) and afterwards your "User" accounts

The Assay Definition File (ADF) enables the device to run the XPERT MTB/RIF programme: use the provided "blue CD" to import an ADF

The Installation Qualification Report is issued at the end of installation and has to be signed and sent to Cepheid (mandatory for GeneXpert warranty)

Summary


List the major components of the instrument package and the major features for the selection of the physical space for installation

List all of the necessary steps to connect the device, install the computer software and create your accounts and reports

Why is it essential to import the Assay Definition File and to send the installation Qualification report to Cepehid?

What can you do to protect the XPERT MTB/RIF programme from misuse or viruses?

Assessment

Acknowledgements

The Xpert MTB/RIF Training Package has been developed by a consortium of GLI partners, including FIND, KNCV, US CDC, USAID, TB CARE I and WHO, with funding from USAID.

The modules are based on materials originally developed by FIND, KNCV and Cepheid.

Documents

Module 5: GeneXpert Installation and Xpert MTB/RIF Set-up Global Laboratory Initiative – Xpert MTB/RIF Training Package Slides adapted from Cepheid