Module 05_INSTALLATION.

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Module 5:
GeneXpert Installation and
Xpert MTB/RIF Set-up
Slides adapted from Cepheid
Global Laboratory Initiative – Xpert MTB/RIF Training Package
Contents of this module

How to unpack GeneXpert system components and place
in laboratory

How to connect components

How to start up computer & software
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How to create Admin and user accounts
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How to import assay definition file
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How to issue “Installation Qualification Report” and its
importance
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Xpert MTB/RIF Training Package
At the end of this module, you will be able to:
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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”
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Xpert MTB/RIF Training Package
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
Unpack the system
and make sure items
are complete
Keep the packaging
and all the provided
documents for
future re-packaging/
expeditions
Barcode reader
Computer
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Monitor, keypad, mouse
GeneXpert
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Xpert MTB/RIF Training Package
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Picture: GeneXpert Users Manual, Cepheid
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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
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Xpert MTB/RIF Training Package

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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 unidirectional. If it does not
detect the GeneXpert
machine, turn the cable
around
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Xpert MTB/RIF Training Package
Desktop computer
version is shown
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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.
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Xpert MTB/RIF Training Package
Laptop computer
version is shown
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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.
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Xpert MTB/RIF Training Package
1.
2.
3.
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Switch on the GeneXpert: a small blue light will
appear on the front panel
Switch on the computer
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
Windows XP
Windows 7
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Xpert MTB/RIF Training Package
4.
Wait until the GeneXpert DX software starts automatically
Windows XP
Windows 7
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)
5.
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Xpert MTB/RIF Training Package
In case the software was closed (computer still on), the software may be
Windows XP
restarted by clicking on the “GeneXpert Dx” icon on the desktop
Windows 7
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Xpert MTB/RIF Training Package
1.
2.
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Set up the local time in the Windows operation system
Windows XP
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
Windows 7
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Xpert MTB/RIF Training Package
3. Set up the options
Windows XP
according to your needs
(automatic printing,
scanning a patient ID
barcode, etc), fromWindows 7
SETPUP → SYSTEM
CONFIGURATION
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Xpert MTB/RIF Training Package
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)
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Xpert MTB/RIF Training Package
Define the person in the lab that will have full access to the software. There can be
more than one Administrator account per system.
1. Click on “Setup/User administration”
NOTE: The first account to be created must be an “Admin” account
2. Click on “Add”
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3. Create user name & password:
(Ideally the same for all machines in the country)
4. Select User type: “Admin”
5. Click on “OK”
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Xpert MTB/RIF Training Package
1. Click on “Setup/User administration”
2. Click on “Add”
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Xpert MTB/RIF Training Package
3. Create user name & password:
(select yourself)
4. Select User type: “Basic”
NOTE: If you select “Detail”,
the user will see the individual
curves for the molecular
beacons.
5. Click on “OK”
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Xpert MTB/RIF Training Package
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Xpert MTB/RIF Training Package
Create a report at the end of installation:
1)
2)
3)
Click on “Reports”, and then on “Installation Qualification”
A PDF file will come up: save this on computer and print a copy
Supervisor signs the report and sends a copy to Cepheid:
[email protected]
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).
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Xpert MTB/RIF Training Package
In order to protect the GeneXpert software it is
recommended to:
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Install the antivirus software that is provided with the
instrument (NortonTM)
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Do not connect the computer to the internet, except
when undergoing Xpert calibration or if connected to a
remote data monitoring system
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Do not use a USB key to transfer files to/from the
computer. Use a CD or hard-disk to collect data
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Xpert MTB/RIF Training Package
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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)
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Xpert MTB/RIF Training Package
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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
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Why is it essential to import the Assay Definition File and
to send the installation Qualification report to Cepehid?
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What can you do to protect the XPERT MTB/RIF
programme from misuse or viruses?
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Xpert MTB/RIF Training Package
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.
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