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Installation of the

GeneXpert® System
(l, II, IV, XVI)
Virtual training for the COVID-19 pandemic

302-3760, Rev. B May 2022


1 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Agenda
1 The Package
2 Environmental & Safety Requirements
3 GeneXpert® System Setup
4 Computer Setup

2 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Learning Objectives
The general objective of this module is to guide you through the installation of
the GeneXpert® System

At the end of the training, you will be able to know more about:

• What is included in the package, and what additional items you would need
• Environmental conditions to consider for proper installation
• Setting up the System equipped either with a desktop or a laptop
• Setting up the Windows Operating System
• GeneXpert® Dx Software setup
• What information to communicate to Cepheid

3 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
The Package

4 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
The Package
GeneXpert® System* Cartridge
• Thermal and optical module(s) (l, II, IV, XVI) • Self-contained
• Disposable
• Computer System and GeneXpert® Dx Software
• Assay Specific Protocol
• Barcode scanner

*cartridge kits are excluded from “The package”

Required but not provided Recommended Accessories Optional Accessories


• Assay Specific collection devices (if applicable) • UPS • Batteries/Power generator
• Assay Specific equipment (if applicable) • Surge protector • Printer
• Personal Protective Equipment
• Timer and Permanent marker
5 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device. * FDA cleared
Environmental & Safety
Requirements

6 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Define the best setting
Before installation, make sure that the GeneXpert® system will be:

In a well-ventilated room

In a temperature controlled (15°-30°C) environment

Not directly under an air conditioning vent or a window and in no direct sunlight

Placed on a stable surface

5-10 cm of clearance surrounding the instrument from the walls or other instruments

Near a power source (maximum 3 required; one when connection to the UPS)

7 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
System Power Consumption Requirements
• Power Supply: Auto Rating
• GeneXpert® Energy Consumption information
On Power Mode Annual Energy Standby Power
System Size
Consumption (W) Consumption (KWh) Consumption
GX-I 61 263 58
GX-II 85 372 71
GX-IV 100 489 83
GX-XVI 270 1168 170
Infinity-48 2426 5840 1248
Infinity-80 2426 5840 1248

• Computer Energy Consumption information


‒ Laptop 350 kW
‒ Desktop 350 kW
8 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Safety Precautions

Injury may result if the System is not lifted properly

It is possible for you or the instrument


to be exposed to biological hazards

The GeneXpert® instrument’s enclosure is designed


to protect operators from electrical shock hazards

9 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
GeneXpert® System Setup
Desktop Configuration

10 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Installation of a GeneXpert® System with Desktop + UPS

See next slide for


APC UPS
installation

11
301-0181, Rev. C
© 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device. US-IVD For in vitro diagnostic use.
Installing APC UPS

12 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device. US-IVD For in vitro diagnostic use.
GeneXpert® System Setup
Laptop Configuration

13 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Installation of a GeneXpert® System with Laptop + UPS

See next slide for


APC UPS
installation

14
301-0180, Rev. C
© 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Installing APC UPS

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Powering Up the System

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Start the GeneXpert® System
1 Switch on the GeneXpert®. 2 Switch on the computer. 3 Operating System:
A blue light appears at the Cepheid-Admin account
front of the System. Password: cphd

17 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Verify successful start-up of the GeneXpert® System
4 The GeneXpert® Dx 5 Verify modules availability. 6 Configure your Windows
software starts Operating System
automatically.

Click No.

18 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Computer Setup
Windows Operating System Configuration

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Setting Local Date and Time
1 Access the Date 2 Set the correct local date 3 Select the correct local
and Time menu. and time. time zone.

20 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
GeneXpert® Dx Software Setup

21 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Software Compatibility
• Verify the software compatibility with the assay version that will be used: New
Assay may require an updated software version.
‒ If you do not have the correct software version, contact Cepheid technical Support

• Assay Definition File (protocol) should be loaded for any new assay added to
the System (slide 27).

22 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
GeneXpert® Dx Software Configuration

System Name
Modify the System Name
(if applicable). Do not use
characters such as
/ \ : * ? “ < > |.

Patient Data
Select the relevant
options as per your need.

Login Option
Decide if the Login request
should come up anytime or
after a defined period.

Additional Options
Set according to your needs
Example: If you need hard copies, put a
check mark on the print report.
23 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Create an Administrator Account (“Admin”)
Define the person in the laboratory that will have full access to the software
There can be more than one Administrator account per System

1 Credentials
Fill in the requested
information and choose
“Admin” as User Type

2 3

Additional users may be defined as Basic or Detail that will have limited access to specific software features.
Refer to the User Type Configuration menu for more details.
24 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device. US-IVD For in vitro diagnostic use.
Import the Assay Definition File (ADF)
Appropriate Assay Definition File needs to be imported prior beginning to work with a new Xpert Assay.
It only needs to be imported once except if notified otherwise.
Insert the CD provided in the cartridge kit in the CD drive of your computer. 3 Locate the CD
1 Choose Define Assays

4 Import the file that end with “.gxa”

Xpert Assay.gxa

Xpert Assay.gxa

2 Click on Import
25 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Data to Collect

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Documents to save
After the installation is complete:
• FAS will complete D6607 document
• The customer will generate an Installation Qualification Report in the
GeneXpert® GX Software, print, sign and send to the FAS before the virtual
training is complete.

Send this information to your regular contact in Cepheid


27 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Records
• Sign and store the Installation Qualification report as proof of installation of your
system
• Remember your GeneXpert® Dx Login and Password
• Collect the Computer Service Tag Number
• In case of future issues, contact Cepheid Technical Support at 888-838-3222
option 2 or register a complaint following the link www.cepheid.com/support

28 © 2020-2022 Cepheid. All rights reserved. US-IVD. In Vitro Diagnostic Medical Device.
Thank You
www.Cepheid.com

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