GeneXpert Express System Users Guide Sw Ver 6.1 Rev B Oct 2019

Preface

Warranty The following information constitutes the Product-specific warranties referenced in the purchase agreement (typically bearing a title such as “Purchase Agreement” or “Sales Agreement”) under which the GeneXpert® system was purchased and the Software described herein was licensed from Cepheid®. Purchaser must not alter or remove any labels, signs, symbols, serial numbers, copyright, patent, trademark, trade secret, proprietary and/or other legal notices contained on or in this Manual, the GeneXpert Xpress system, GeneXpert Software, and related documentation. GeneXpert Limited Warranty Cepheid warrants that (i) the GeneXpert system (the “system”) is free from defects in material and workmanship, (ii) the system together with the GeneXpert Xpress system software (the “Product”) conforms to Cepheid's published specifications, and (iii) the Product conforms to the labeling claims that accompany the system. This Warranty is for a period of 12 months from the date of shipment to the Purchaser (the Warranty Period). During the Warranty Period, if the system's hardware is found to be defective or if the Product is found to be non-conforming under item (ii) or (iii) above, Cepheid will repair or replace it, at a site determined by Cepheid at Cepheid's expense. This warranty extends to Purchaser only and not to any other parties, except as agreed to in writing by Cepheid, and applies only to new products manufactured by Cepheid. Cepheid does not warrant any defects in the system caused by (i) improper installation, removal or testing, (ii) Purchaser's failure to provide a suitable operating environment for the system, (iii) use of the system for purposes other than that for which it was designed, (iv) unauthorized attachments, (v) unusual physical or electrical stress, (vi) modifications or repairs done by other than Cepheid or a Cepheid authorized service provider, or (vii) any other abuse, misuse, or neglect of the system. The system is designed and certified with applicable regulatory authorities as part of an integrated instrument/reagent/consumable system. Use of unapproved parts, reagents or other materials with the system will void any warranty and any service contract between Cepheid and the Purchaser that pertains to the system. OTHER THAN ANY EXPRESS WARRANTY PROVIDED IN THE ORIGINAL PURCHASE AGREEMENT WITH CEPHEID, THERE ARE NO WARRANTIES WHICH EXTEND BEYOND THE FACE HEREOF, AND CEPHEID DISCLAIMS ALL OTHER REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, REGARDING THE PRODUCT, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. CEPHEID AND ITS DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS SHALL HAVE NO LIABILITY FOR GENERAL, CONSEQUENTIAL, INCIDENTAL OR SPECIAL DAMAGES ARISING FROM A DEFECT IN THE SYSTEM. FURTHERMORE, CEPHEID SHALL HAVE NO STRICT LIABILITY, PRODUCTS LIABILITY OR NEGLIGENCE LIABILITY, WHETHER ACTIVE OR PASSIVE, AS TO THE PURCHASER. Purchaser's exclusive remedy for any defective system or non-conforming Product is limited to the repair or replacement of any defective system. If Cepheid cannot or does not repair or replace a defective system or non-conforming Product, Cepheid will remove same and return the purchase price. If Cepheid cannot or does not repair or replace any defective system or non-conforming Product or if Purchaser's exclusive remedy fails of its essential purpose, Cepheid's entire liability shall in no event exceed the purchase price for any defective system or non-conforming Product.

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Preface

Cepheid GeneXpert Xpress System and Xpress Software License Agreement Cepheid is the exclusive owner of the Cepheid GeneXpert Xpress System Software programs (the "Software"), related documentation and physical media, and of all copyright, trade secret, patent, trademark and other intellectual or industrial property rights therein. Physical media and copies of the Software, whether in diskette, tape, paper or other form, shall remain the property of Cepheid, and such copies are deemed to be on loan to Purchaser during the term of the License granted hereby. Purchaser expressly acknowledges that no title to or ownership of the Software, or any copy or portion thereof, is transferred to Purchaser. The ideas and expressions thereof contained in the Software are confidential, proprietary information and trade secrets of Cepheid that are provided to Purchaser. Purchaser shall not cause or permit decompilation, disassembly, or reverse engineering of the Software or disclosure, copying, display, loan, publication, transfer of possession (whether by sales, exchange, gift, operation of law or otherwise) or other dissemination of the Software and related documentation, in whole or part, to any third party without the prior written consent of Cepheid. License Grant: Cepheid grants Purchaser a non-exclusive, non-transferable license (the "License") to use only one (1) copy of the Software on the computer provided by Cepheid with the GeneXpert Instrument(s) and connected to the GeneXpert Instrument(s), and to make only one (1) copy solely for back-up purposes. Purchaser shall not otherwise copy and shall not modify, duplicate, translate, disassemble, or decompile the Software without Cepheid's prior written consent. If the Software is used on a computer other than the one provided by Cepheid for the GeneXpert Xpress system, Cepheid will not guarantee performance and cannot provide technical support for problems arising therefrom. Purchaser may not use this single-user product on a network. This License entitles Purchaser to use toll-free telephone support as provided by Cepheid. This License is effective until terminated. Cepheid may terminate this License if Purchaser fails to comply with any of the terms or conditions of this License or of the original purchase agreement. If this License is terminated, Purchaser must destroy all copies of the Software and its related documentation. For Government Purchasers, the Software is commercial computer software subject to restricted rights under FAR 52.227-19 (C) (1, 2). NO OTHER RIGHTS ARE CONVEYED EXPRESSLY, BY IMPLICATION OR BY ESTOPPEL TO ANY OTHER PATENTS. FURTHERMORE, NO RIGHTS FOR RESALE ARE CONFERRED WITH THE PURCHASE OF THIS PRODUCT. Trademark and Copyright Statements Cepheid®, the Cepheid logo, GeneXpert®, Xpress and I-CORE® are trademarks of Cepheid. Ethernet® is a registered trademark of Xerox Corporation. Microsoft® and Windows® are registered trademarks of Microsoft Corporation. All other trademarks are the property of their respective owners. This Manual contains information protected by copyright. No part of this Manual may be photocopied or reproduced in any form without prior written consent from Cepheid. © Cepheid 2019 - All rights reserved.

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Preface

Disclaimers All examples (printouts, graphics, displays, screens, etc.) are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual patient names or test results. Labels depicted in the manual may appear different from actual product labels. Cepheid makes no representations or warranties about the accuracy and reliability of the information contained in the GeneXpert Xpress User’s Guide. The information was developed to assist the user in the operation of the GeneXpert Xpress system. Updates to this GeneXpert Xpress User’s Guide may be issued periodically and should be maintained with this original manual. Part 15 Compliance This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. California Proposition 65 Warning Warning

iv

This product can expose you to chemicals including Nickel, which is known to the State of California to cause cancer or birth defects or other reproductive harm. For more information, visit www.P65Warnings.ca.gov.

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Preface About This Guide The GeneXpert Xpress User’s Guide describes the user operation and maintenance of the GeneXpert Xpress system. Information is provided about safely using the system with the GeneXpert Xpress software and performing maintenance. Information about the antivirus software and its operation is also included. Read the entire manual and become familiar with the safety information before you start to operate the system. Using the system without reading the manual can result in serious injury, damage to the system, invalid results, or loss of data.

Safety Information Chapter 2 (Safety) in this manual provides important safety information that you should use when operating the GeneXpert Xpress system. Read and understand the safety information thoroughly before you begin operating the system. Make sure you follow the precautionary statements presented in this guide: Warning A warning indicates a possibility of adverse reactions, injury or death to the user or other persons if the precautions or instructions are not observed. Caution A caution indicates that damage to the system, loss of data or invalid results could occur if the user fails to comply with the advice given.

Important

An important note highlights information that is critical for the completion of a task or the optimal performance of the system.

Note

A note identifies information that is useful for completion of a task or identifies information that applies only in special cases.

The warnings and cautions always use the same keyword but the icon may change to more clearly indicate the type of hazard.

Related Documents For other information outside the scope of this document, see the following publications: •

GeneXpert Xpress System Getting Started Guide (P/N 302-1345)

•

Assay Quick Reference Instructions (P/N varies, specific to the assay being run)

•

Assay Package Insert (P/N varies, specific to the assay being run)

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Preface

Table of Symbols The following symbols and icons are used in this manual and on the system labels: Symbol

Meaning In vitro diagnostic medical device CE marking-European Conformity Do not reuse Consult instructions for use Manufacturer Separate collection for electrical and electronic equipment waste per Directive 2002/96/EC in the European Union. This type of warning label indicates a potential biological hazard risk. Biological samples such as tissues, body fluids, and blood of humans and/or animals have the potential to transmit infectious diseases. Follow your local, state/ provincial, and national safety regulations for handling and disposing the samples. This type of warning label indicates that hazardous high voltage sections are present in the electrical system in the GeneXpert Xpress. Do not remove covers with this warning label. This type of symbol indicates a Warning or Caution for which there is no other identified symbol. Read the instructions following the symbol to avoid injury or equipment damage.

Cepheid Headquarters Locations Corporate Headquarters

European Headquarters

Cepheid 904 Caribbean Drive Sunnyvale, CA 94089-1189 USA

Cepheid Europe SAS Vira Solelh 81470 Maurens-Scopont France

Telephone: +1 408.541.4191

Telephone: +33 563 82 53 00

Fax: +1 408.541.4192

Fax: +33 563 82 53 01

www.cepheid.com

www.cepheidinternational.com

Email: [email protected]

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Preface

Technical Assistance For assistance, contact Cepheid using one of the following contact details. Before contacting Cepheid Technical Support, collect the following information: •

Product name

•

Lot number

•

Serial number of the instrument

•

Error messages (if any)

•

Software version and, if applicable, hub serial number Region

Telephone

Email

US

+1 888.838.3222, Option 2

[email protected]

Contact information for other Cepheid offices is available on our website at www.cepheid.com or www.cepheidinternational.com under the SUPPORT tab. Select the Contact Us option.

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Table of Contents 1

2

3

Introduction... 1-1 1.1

Intended Use... 1-1

1.2

Software Installation... 1-1

1.3

System Components... 1-2

1.4

LIS Uploads and Downloads... 1-3

1.5

Anti-virus Software... 1-3

1.6

Network Connection... 1-4

1.7

Windows® User Accounts... 1-4

1.8

Software Buttons, Icons and Symbols... 1-4

1.9

Creating Patient/Sample IDs... 1-6

Safety... 2-1 2.1

Electrical Symbols on the Hub and Instrument... 2-1

2.2

Electrical Safety... 2-2

2.3

Biological Hazard Safety... 2-2

2.4

Chemical Safety... 2-2

2.5

Environmental Data... 2-3

2.6

Barcode Scanner... 2-3

Operation... 3-1 3.1

Starting the GeneXpert Xpress System... 3-2

3.2

Running a Test Using the GeneXpert Xpress Software... 3-5 3.2.1 Starting a Test... 3-6 3.2.2 Entering the Patient ID... 3-7 3.2.2.1 3.2.2.2

3.2.3

Entering the Sample ID... 3-10 3.2.3.1 3.2.3.2

3.2.4 3.2.5

Scan the Patient ID... 3-8 Enter the Patient ID Manually... 3-9 Scan the Sample ID... 3-10 Enter the Sample ID Manually... 3-11

Scan Cartridge Barcode... 3-13 Load Cartridge into Module... 3-18

3.3

Starting a Test While Another Test is Running... 3-22

3.4

Viewing Previous Test Results... 3-24

3.5

User Menu Functions... 3-27 3.5.1 Log In and Log Out... 3-27 3.5.1.1 3.5.1.2

Manual Login using the Virtual Keyboard... 3-28 Institutional ID Login... 3-29

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3.5.2 3.5.3

Changing Your Password... 3-31 Exiting the Software... 3-32

3.6

Quality Control Lockout (Optional)... 3-32 3.6.1 Quality Control... 3-32 3.6.2 Quality Control Lockout... 3-34 3.6.3 Running a Quality Control Test... 3-34 3.6.4 Entering the Sample ID... 3-35

3.7

Operating with Host (LIS) Connectivity... 3-45 3.7.1 Creating a Test with Host Connectivity... 3-45 3.7.2 Uploading a Test Result to the Host... 3-47 3.7.2.1 3.7.2.2

3.7.3

4

Troubleshooting Host Connectivity... 3-48

3.8

Exiting the Software and Turning Off the System... 3-49

3.9

Error Handling... 3-52

3.10

Using the Virtual Keyboard... 3-53

3.11

The About and License Screens... 3-53

Administrative Tasks... 4-1 4.1

Powering Up the GeneXpert System... 4-2

4.2

Starting the GeneXpert Xpress Software... 4-8

4.3

Xpress Home Screen - Accessing Admin Functions... 4-8

4.4

Administration Tasks... 4-10 4.4.1 Reports... 4-10 4.4.1.1 4.4.1.2

4.4.2 4.4.3 4.5

System Log... 4-11 Installation Qualification Report... 4-14

Instrument... 4-17 Managing Users... 4-18

Data Management Tasks... 4-20 4.5.1 Retrieving Tests... 4-20 4.5.2 Archiving Tests... 4-20 4.5.3 Retrieving Data from an Archive File... 4-24 4.5.4 Purging Tests from the Database... 4-26 4.5.5 Database Management... 4-26 4.5.5.1 4.5.5.2

4.5.6

Backing Up the Database... 4-27 Restoring the Database... 4-28

Managing Assays... 4-35 4.5.6.1 4.5.6.2 4.5.6.3

TOC-2

Manually Uploading a Test Result to the Host... 3-48 Uploading a QC Result to the Host... 3-48

Delete Assay(s)... 4-35 Connecting a DVD Drive to the Xpress System... 4-37 Importing Assay Definition... 4-37

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4.6

System Configuration... 4-39 4.6.1 General Settings... 4-40 4.6.2 Folders... 4-40 4.6.3 QC Lockout Settings... 4-42 4.6.4 Archive Settings... 4-44 4.6.5 Configuring the Barcode Scanner... 4-45

4.7

Setting the IP Address for Instrument Communication... 4-46

4.8

User Functions by Roles... 4-50

4.9

Host (LIS) Management and Settings... 4-51 4.9.1 Managing Host Orders... 4-51 4.9.2 Host Test Code Settings... 4-53 4.9.2.1

4.9.3 4.10

Host (LIS) Communication Settings... 4-55

Operating with Host (LIS) Connectivity (Admin Only)... 4-57 4.10.1 Creating a Test with Host Connectivity... 4-58 4.10.1.1 4.10.1.2 4.10.1.3 4.10.1.4 4.10.1.5

4.10.2

4.10.3

Creating a Test by Selecting from a List of Test Orders Downloaded by the Host Automatically... 4-60 Creating a Test by Manually Requesting Test Orders and Selecting From the List of Test Orders... 4-61 Creating a Test by Querying the Host with Sample ID... 4-61 Aborting a Query... 4-63 Deleting a Host Downloaded Test Order... 4-64

Uploading a Test Result to the Host... 4-64 4.10.2.1 4.10.2.2 4.10.2.3

5

Using the Host Test Code Screen... 4-54

Automatically Uploading the Test Result to the Host... 4-64 Manually Uploading a Test Result to the Host... 4-66 Uploading a QC Result to the Host... 4-66

Troubleshooting Host Connectivity... 4-66

Maintenance... 5-1 5.1

Maintenance Tasks... 5-2

5.2

Maintenance Log... 5-2

5.3

Guidelines for Cleaning and Disinfecting... 5-4

5.4

Daily Maintenance... 5-5 5.4.1 Cleaning the Work Area... 5-5 5.4.2 Close Module Doors... 5-5 5.4.3 Discard Used Cartridges... 5-5

5.5

Weekly Maintenance... 5-5 5.5.1 Power Down the System... 5-5

5.6

Monthly Maintenance... 5-6 5.6.1 Cleaning and Replacing the GX-IV Fan Filter... 5-6

5.7

Quarterly Maintenance... 5-9

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5.7.1 5.7.2

A

TOC-4

Cleaning the GeneXpert Hub and Instrument Surfaces... 5-10 Cleaning the Plunger Rods and Cartridge Bays... 5-11

5.8

Yearly Instrument Maintenance... 5-18

5.9

In Case of Spill... 5-18

5.10

Module Reporters (Module Maintenance Screen)... 5-18

5.11

Performing a Manual Self-Test... 5-20

5.12

Excluding Modules from Testing... 5-22

5.13

Generating the System Log Report... 5-23

5.14

Replacing Hub and Instrument Parts... 5-24

5.15

Repairing the Hub or Instrument... 5-24

5.16

Troubleshooting... 5-25 5.16.1 Troubleshooting the LIS Interface... 5-26

Performance Characteristics and Specifications... A-1 A.1

Instrument Classification... A-1

A.2

General Specifications for the GeneXpert Xpress System... A-2

A.3

Operational Environmental Parameters... A-2

A.4

Environmental Conditions - Storage and Transport... A-3

A.5

Sound Pressure... A-3

A.6

Product Energy Consumption Information... A-3

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List of Figures Figure 1-1

GeneXpert Xpress System at a Glance... 1-2

Figure 3-1

Rear of GeneXpert Xpress System, showing Power Switches... 3-2

Figure 3-2

GeneXpert Computer Power Indicator/Switch (Right Front of System)... 3-3

Figure 3-3

Windows Opening Screen... 3-3

Figure 3-4

Windows Login Screen... 3-4

Figure 3-5

Windows Login Screen with Keyboard... 3-4

Figure 3-6

GeneXpert Xpress System Shortcut Icon... 3-5

Figure 3-7

Login to Xpress Software Screen... 3-6

Figure 3-8

Home Screen (GX-IV, Four-Module Configuration Shown)... 3-7

Figure 3-9

Integrated Barcode Scanner... 3-8

Figure 3-10

Patient Information Screen... 3-9

Figure 3-11

Confirm Patient Information Screen... 3-10

Figure 3-12

Correct Placement for Scanning a Sample... 3-11

Figure 3-13

Virtual Keyboard... 3-12

Figure 3-14

Sample ID Screen... 3-12

Figure 3-15

Confirm Sample ID Screen... 3-13

Figure 3-16

Scan Cartridge Barcode Screen... 3-14

Figure 3-17

Correct Placement for Scanning a Cartridge... 3-14

Figure 3-18

Select Test Screen (for Combinatorial Assays only)... 3-15

Figure 3-19

Confirm Test Screen... 3-16

Figure 3-20

Login Screen... 3-17

Figure 3-21

Cartridge Preparation Screen... 3-17

Figure 3-22

Load Cartridge to Module Screen... 3-18

Figure 3-23

Cartridge Inserted into Module... 3-18

Figure 3-24

Test Loading Screen showing Cartridge Loading... 3-19

Figure 3-25

Test in Progress Screen showing Test Time Remaining... 3-20

Figure 3-26

Test Completed Screen... 3-20

Figure 3-27

Screen showing Test Report of Test Just Completed (Partial View Shown)... 3-21

Figure 3-28

Test Running Screen - Going to the Home Screen to Start a New Test... 3-22

Figure 3-29

Home Screen, showing Three Available Modules... 3-23

Figure 3-30

Home Screen showing Two Tests Running... 3-23

Figure 3-31

Home Screen with One of Two Tests Completed... 3-24

Figure 3-32

Home Screen (GX-IV, Four-Module Configuration Shown)... 3-25

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List of Figures

Figure 3-33

Results Screen showing a Listing of Previous Test Results Completed... 3-25

Figure 3-34

Test Completed Screen... 3-26

Figure 3-35

Home Screen (GX-IV, Four-Module Configuration Shown)... 3-27

Figure 3-36

The Xpress User Menu... 3-28

Figure 3-37

Login to Xpress Software Screen... 3-29

Figure 3-38

Login to GeneXpert Xpress System Screen... 3-30

Figure 3-39

Home Screen showing the User Menu icon... 3-30

Figure 3-40

Test Completed Screen with User Drop-Down Menu... 3-31

Figure 3-41

Change Password Screen... 3-32

Figure 3-42

Select Quality Control Type Screen... 3-33

Figure 3-43

Quality Control Summary Screen... 3-33

Figure 3-44

Home Screen (GX-IV, Four-Module Configuration Shown)... 3-34

Figure 3-45

Quality Control Screen... 3-35

Figure 3-46

Sample ID Screen... 3-35

Figure 3-47

Confirm Sample ID Screen... 3-36

Figure 3-48

Scan Cartridge Barcode Screen... 3-37

Figure 3-49

Confirm Test Information Screen... 3-37

Figure 3-50

Confirm Quality Control Test Screen... 3-38

Figure 3-51

Select Test Screen (for Combinatorial Assays only)... 3-39

Figure 3-52

Login Screen... 3-39

Figure 3-53

Cartridge Preparation Screen... 3-40

Figure 3-54

Load Cartridge into Module Screen... 3-40

Figure 3-55

Cartridge Inserted into Module... 3-41

Figure 3-56

Test Loading Screen showing Cartridge Loading... 3-42

Figure 3-57

Test in Progress Screen showing Test Time Remaining... 3-42

Figure 3-58

QC Test Result - Positive Pass Screen... 3-43

Figure 3-59

QC Test Result - Negative Pass Screen... 3-43

Figure 3-60

Screen showing Test Report of Test Just Completed (Partial View Shown)... 3-44

Figure 3-61

No Matching Orders Found Dialog Box... 3-46

Figure 3-62

Select Host Order Screen... 3-46

Figure 3-63

Test Upload Status shown on the Test Completed Screen... 3-47

Figure 3-64

Touch UPLOAD to Upload the Test Result to the Host... 3-48

Figure 3-65

Home Screen showing the User Menu Icon... 3-49

Figure 3-66

Home Screen showing User Drop-Down Menu, with Exit Selected... 3-50

Figure 3-67

GeneXpert Xpress Hub, showing Blue Power Switch... 3-50

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List of Figures

Figure 3-68

GeneXpert Xpress Hub Power Switch (Rear of Hub)... 3-51

Figure 3-69

Turn OFF the Instrument... 3-51

Figure 3-70

Cartridge Already Used Error Screen... 3-52

Figure 3-71

Virtual Keyboard Operation... 3-53

Figure 3-72

Home Screen... 3-54

Figure 3-73

Home Screen, showing User Drop-Down Menu and About Selection... 3-54

Figure 3-74

About Screen... 3-55

Figure 3-75

License Information Screen... 3-55

Figure 4-1

Windows Opening Screen... 4-2

Figure 4-2

Windows Login Screen... 4-3

Figure 4-3

Cepheid-Admin Login Screen... 4-4

Figure 4-4

Cepheid-Admin Login Screen with Virtual Keyboard... 4-5

Figure 4-5

.Change Password Screen... 4-6

Figure 4-6

Windows Password Dialog Box... 4-6

Figure 4-7

Password Confirmation Screen... 4-7

Figure 4-8

GeneXpert Xpress System Shortcut Icon... 4-7

Figure 4-9

Login to GeneXpert Xpress System Screen... 4-8

Figure 4-10

Xpress Home Screen... 4-9

Figure 4-11

Admin Screen... 4-9

Figure 4-12

Reports Selected on the Administration Screen... 4-10

Figure 4-13

Reports Screen... 4-10

Figure 4-14

System Log Screen... 4-12

Figure 4-15

System Log Report... 4-13

Figure 4-16

Installation Qualification Report - Initial (Partial View)... 4-14

Figure 4-17

Installation Qualification Report - Page 1 of 2... 4-15

Figure 4-18

Installation Qualification Report - Page 2 of 2... 4-16

Figure 4-19

Instrument Selected on the Administration Screen... 4-17

Figure 4-20

Instrument Screen... 4-17

Figure 4-21

Manage Users Selected on the Administration Screen... 4-18

Figure 4-22

Manage Users Screen... 4-18

Figure 4-23

Add User Screen... 4-19

Figure 4-24

Admin Screen... 4-20

Figure 4-25

Admin Screen... 4-21

Figure 4-26

Archive Tests Screen - View 1... 4-21

Figure 4-27

Archive Tests Screen - View 2... 4-22

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List of Figures

Figure 4-28

Archive Confirmation Screen... 4-23

Figure 4-29

Archive Information Screen... 4-23

Figure 4-30

Archive Open Dialog Screen... 4-24

Figure 4-31

Archive Confirmation Screen... 4-25

Figure 4-32

Retrieving Tests Screen... 4-25

Figure 4-33

Admin Screen... 4-27

Figure 4-34

Database Maintenance Screen... 4-27

Figure 4-35

Database Backup Screen, showing Default Filename... 4-28

Figure 4-36

Database Maintenance Screen... 4-29

Figure 4-37

Database Restore Confirmation Advisory... 4-29

Figure 4-38

Database Backup File Folder... 4-30

Figure 4-39

Database Restore Completion Advisory... 4-31

Figure 4-40

Database Backup File Folder... 4-32

Figure 4-41

Database Backup is Complete Advisory... 4-32

Figure 4-42

Database Restore Overwrite Advisory... 4-33

Figure 4-43

Database Backup File Folder... 4-34

Figure 4-44

Database Restore Completion Advisory... 4-34

Figure 4-45

Admin Screen... 4-35

Figure 4-46

Manage Assays Screen... 4-36

Figure 4-47

Manage Assays Screen... 4-36

Figure 4-48

Manage Assays Screen showing the Import Assay Function... 4-37

Figure 4-49

File Screen, showing the Assay File to be Imported... 4-38

Figure 4-50

File Screen, showing the Assay File to be Imported... 4-38

Figure 4-51

Admin Screen... 4-39

Figure 4-52

General Settings Screen... 4-40

Figure 4-53

Admin Screen... 4-41

Figure 4-54

Folders Screen... 4-41

Figure 4-55

Admin Screen... 4-42

Figure 4-56

QC Lockout Settings Screen... 4-43

Figure 4-57

QC Lockout Settings Screen - Showing Drop Down Menu Selections... 4-43

Figure 4-58

Admin Screen... 4-44

Figure 4-59

Archive Settings Screen... 4-44

Figure 4-60

Admin Screen... 4-45

Figure 4-61

Matrix to Scan to Reconfigure the Barcode Scanner... 4-45

Figure 4-62

Configure Barcode Scanner Screen... 4-46

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List of Figures

Figure 4-63

All Control Panel Items Window-Category View... 4-47

Figure 4-64

Network and Sharing Center Screen... 4-47

Figure 4-65

Network Connections Screen... 4-48

Figure 4-66

Network Connections Screen with Drop-Down Menu... 4-48

Figure 4-67

GeneXpert Connection Properties Screen... 4-49

Figure 4-68

Internet Protocol Version 4 (TCP/IPv4) Properties Screen... 4-49

Figure 4-69

Admin Screen... 4-51

Figure 4-70

Manage Host Orders... 4-52

Figure 4-71

Admin Screen... 4-53

Figure 4-72

Host Test Code Settings... 4-53

Figure 4-73

Admin Screen... 4-55

Figure 4-74

Host Communications Settings... 4-56

Figure 4-75

Select Host Order Screen... 4-58

Figure 4-76

Manage Host Orders Screen... 4-59

Figure 4-77

Automatic Test Order Download Selected... 4-60

Figure 4-78

Select Host Order Screen... 4-61

Figure 4-79

Select Host Query... 4-62

Figure 4-80

Manage Host Orders screen, showing the Manual/Abort Query Button... 4-63

Figure 4-81

Deleting a Host Downloaded Test Order... 4-64

Figure 4-82

Automatic Result Upload... 4-65

Figure 4-83

Test Upload Status shown on the Test Completed Screen... 4-65

Figure 4-84

Touch UPLOAD to Upload the Test Result to the Host... 4-66

Figure 5-1

Maintenance Log... 5-3

Figure 5-2

GeneXpert Xpress IV Instrument Positioned for Access to Fans... 5-7

Figure 5-3

Removing Instrument Fan Filter Guard... 5-7

Figure 5-4

Instrument Filter Removal... 5-8

Figure 5-5

Installing the Instrument Fan Filter Guard Sides... 5-8

Figure 5-6

Installing the Instrument Fan Filter Guard Bottom... 5-9

Figure 5-7

Home Screen (GX-IV, Four-Module Configuration Shown)... 5-12

Figure 5-8

Instrument Selected on the Administration Screen... 5-12

Figure 5-9

Instrument Screen... 5-13

Figure 5-10

Plunger Rod Maintenance Screen... 5-13

Figure 5-11

Plunger Rod Maintenance Screen, with Module A1 Selected... 5-14

Figure 5-12

Cartridge Removal Instruction Screen... 5-14

Figure 5-13

Plunger Rod Cleaning Instruction Screen... 5-15

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List of Figures

Figure 5-14

Plunger Rod Lowered into Cartridge Bay... 5-15

Figure 5-15

Plunger Rod Repositioning Advisory Screen... 5-17

Figure 5-16

Instrument Screen... 5-17

Figure 5-17

Instrument Screen... 5-19

Figure 5-18

Module Maintenance Screen, showing Module Reporters... 5-19

Figure 5-19

Instrument Screen... 5-20

Figure 5-20

Module Maintenance Screen, showing Module Reporters... 5-21

Figure 5-21

Module Self-Test Confirmation Dialog Box... 5-21

Figure 5-22

Module Maintenance Screen, showing Module Available... 5-22

Figure 5-23

Instrument Screen... 5-23

Figure 5-24

Module Maintenance Screen, showing Module Reporters... 5-23

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List of Tables Table 1-1

GeneXpert Xpress System at a Glance... 1-3

Table 1-2

Software Buttons, Icons and Symbols... 1-4

Table 2-1

Electrical Symbols on the Hub and Instrument... 2-1

Table 4-1

User Functions by Roles... 4-50

Table 5-1

Maintenance Tasks and Frequency... 5-2

Table 5-2

Hardware Problems... 5-25

Table 5-3

System Configuration Problems... 5-26

Table A-1

System Dimensions and Weights... A-2

Table A-2

Rated Current and Fuse Rating... A-2

Table A-3

Product Energy Consumption... A-3

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