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1 © Cepheid Proprietary & Confidential © 2012 Cepheid 1 Installation of the system

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Page 1: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

1 © Cepheid – Proprietary & Confidential © 2012 Cepheid 1

Installation of the

system

Page 2: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

2 © Cepheid – Proprietary & Confidential

To start with the GeneXpert

Provided:

• GeneXpert® System (GeneXpert + Computer + Barcode scanner)

• Xpert® assay

Not provided:

• Translucent, screw-capped specimen collection containers

• Lab coat/ Disposable gloves/Respiratory protection

• Timer

• Indelible labeling marker

Optional:

• Safety Cabinet, up to the institution to decide if safety cabinet is required

• Printer

• Surge protector - UPS

• Additional 2 ml plastic transfer pipettes

Page 3: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

3 © Cepheid – Proprietary & Confidential

Optimal installation: define the best location

What to check before installation

1- Well ventilated room

2- Not directly under an air conditioning vent or window (no direct sunlight)

3- Be on a stable bench work, no centrifuge close to the system

4- 10-15 cm surround the instrument from the walls.

5 - Near power source (1 available if connected to UPS/surge protector)

6- Control the lab temperature (15-30 degrees)

Page 4: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

4 © Cepheid – Proprietary & Confidential

Installation of a system with Desktop

Page 5: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

5 © Cepheid – Proprietary & Confidential

Installation of a system with Laptop

Page 6: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

6 © Cepheid – Proprietary & Confidential

Start the Windows Operating System

(Windows XP - 1st generation)

Switch on the GeneXpert®: a small blue light will appear at the front panel of the system

Switch on the Computer

Open the Windows XP session: Username: Cepheid Password: cphd

1

2

3

Page 7: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

7 © Cepheid – Proprietary & Confidential

Start the Windows Operating System

(Windows 7 - 2nd generation)

Switch on the GeneXpert®: a small blue light will appear at the front panel of the system

Switch on the Computer

Open the Windows 7 session:

Select the Username Cepheid and Type the password: cphd

1

2

3

Page 8: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

8 © Cepheid – Proprietary & Confidential

Prepare your system for the routine use

In the Check Status screen, verify that all modules are available

Please wait a little until the GeneXpert® DX software starts automatically

When you will start the program, the question “Do you want to

perform database management task “ will appear:

Click on NO when you begin your working day

(If modules are not available, please refer to chapter 11 of the Operator Manual and contact Cepheid technical support)

4

5

Page 9: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

9 © Cepheid – Proprietary & Confidential

In case the software was closed

(computer still opened), to reopen it,

double - click on the «GeneXpert DX»

icon on the desktop and follow steps 4

and 5 page 3)

Prepare your system for the routine use

Page 10: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

10 © Cepheid – Proprietary & Confidential

Optimal installation: configuration of the Software

Set up the local time in Windows Operating System (do not change the unicode country)

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 below screen

Set up the options according to the need (automatic printing, scanning the patient-sample ID barcode from

SETUP SYSTEM CONFIGURATION see below screen

1

2

3

Page 11: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

11 © Cepheid – Proprietary & Confidential

Optimal installation: configuration of the Software

2

3

Page 12: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

12 © Cepheid – Proprietary & Confidential

Create an Administrator Account (“Admin”)

Click on (“Add”)

Select Setup

User

administration

Define the person in the lab that will have full access on the software. Can be more than one

Administrator account per system.

1

2

Page 13: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

13 © Cepheid – Proprietary & Confidential

Enter the Username

and Password

Choose the User type

(Admin)

Click on OK

Create an Administrator Access (“Admin”)

3

4

5

Page 14: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

14 © Cepheid – Proprietary & Confidential

Create a Basic Account

Click on (“Add”)

Define the persons in the lab that will have limited access to the software. Can be more than

one Basic account per system.

2

Select Setup User administration 1

Page 15: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

15 © Cepheid – Proprietary & Confidential

Remarks: The basic access will only be able to see the results without the

graphics.

Create an Basic Account (“Basic”)

Enter the Username

and Password

Choose the User type

(Basic)

Click on OK

3

4

5

Page 16: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

16 © Cepheid – Proprietary & Confidential

How to login

Enter your User

Name and Password 2

Select User Login 1

Click OK 3

Page 17: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

17 © Cepheid – Proprietary & Confidential

In order to update your warranty status, please generate a report to complete your installation:

Go to: Reports Installation Qualification

Installation Qualification Report

Save this report

Send this file by email to [email protected]

with :

- contact name

- phone number

- email address of the contact

- physical address of the system

Note: without reception of these information, the warranty will be considered as starting the

day of shipment.

Page 18: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

18 © Cepheid – Proprietary & Confidential

Create a test

Routine use

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19 © Cepheid – Proprietary & Confidential

Create a test

Click on CREATE TEST A dialogue box will appear:

Please scan cartridge barcode

Press the yellow button of

the barcode scanner and

scan the cartridge 1 2 3

Page 20: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

20 © Cepheid – Proprietary & Confidential

The module will be

automatically

selected

DO NOT

CHANGE IT

Fill in the Sample

ID

Click on Start Test

Patient ID

Fill in the Patient ID

if available

Sample ID

A green light will blink

from a given module:

Open the door and place

the cartridge

Fully close the module

door, the test starts

immediately

Wait 2 hours to see

your result

4

5

6

7

8

Create a test

Once done, the below screen will appear

9

Page 21: Installation of the system - GHDonlineInstallation Qualification Report Save this report Send this file by email to training@cepheidhbdc.com with : - contact name - phone number -

21 © Cepheid – Proprietary & Confidential

Service Telephone Email address

Training Center (Europe) +33.5.63.82.5(386)/(378)/(360) [email protected]

Technical hotline (Europe based)-

Instrument errors

+33.5.63.82.53.19 [email protected]

Technical hotline ( U.S.A based)-

Instrument errors

888-838-3222, Option 2 [email protected]

Should you need some training please contact us or your local service provider if available in your country.

When Contacting Cepheid, please prepare: The Serial number of the GeneXpert, the recorded error messages, the description of

the incident and when possible the archived runs concerned

http://www.cepheidcares.com/tb/resources

Assistance from Cepheid

Information of the system

Serial number of your GeneXpert (at the back side, near the power button)

Computer Service Express Service Tag Number

Installation date of the system … / … / ….

Windows Password (Should never be changed) cphd