pi1066 eplex operator manual - genmark · chapter6.settings 62 generalsettings 62 installsoftware...

OperatorManual

ePlexOperatorManual 1 /119

PI1066Rev. F

Chapter 1. Table of Contents

Chapter 1. Preface 8

About this Manual 8

How to Use this Manual 8

Getting Help 8

United States 9

International 9

ePlex Manufacturer 10

Corporate Headquarters 10

International Locations 10

AuthorizedRepresentative 10

Other Locations 11

Chapter 2.Compliance and Safety 12

General Safety Precautions 12

Safety Symbols 12

Symbols Used in the Manual and on ePlex Instrument Labels 12

Compliance 13

ElectromagneticCompatibility (EMC) 13

Standards 13

Warnings andHazards 13

SystemHandlingWarnings 13

EnvironmentalWarnings 14

CartridgeHandlingWarnings 14

BiologicalHazards 15

ElectricalHazards 15

Glove Usage 15

Change gloves before: 16

Change gloves after: 16

Chapter 3. SystemOverview 17

Digital Microfluidics: Electrowetting Technology 17

eSensor Technology 18

Components 19

Operation 23

Navigating the User Interface 25

Help Screen 27

Updating HelpContent 27

Screen Capture 27


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Logging Out andShutting Down 28

Logout 28

Restart 28

Shutdown 28

Run View 29

OutstandingAccession IDView 30

BayDetailsView 31

Chapter 4. Using the System 33

User Roles andRights 33

Power on the System 34

Logging In 36

Using the Touchscreen 36

Preparing Cartridges 38

Starting a Run 38

ManualEntry 38

BarcodeScanner 39

PendingTestOrders (PTO)ManualRun 39

Using the Barcode Scanner 39

Barcode Scanning Tips 40

Inserting Cartridges into ePlex 41

Pending Test Orders 42

Managing Pending Test Orders 43

Manual ImportingofPendingTestOrders 44

SearchPendingTestOrders 44

DeletePendingTestOrders 44

Color Status Indicators 44

Monitoring the Run 45

Entering/EditingAccession ID, Patient ID, andComments 45

BayErrors 46

AlertNotifications 47

Aborting a Run 47

Cartridge Removal 48

Generating and Viewing Reports 48

Chapter 5. Reports 50

Detection Report 50

External Control Report 54

Summary Report 57

User Access Report 59

SystemManifest Report 60


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Chapter 6. Settings 62

General Settings 62

Install Software 64

Restart Software 65

Set Auto Logout 66

Set Password Expiration 66

Report Settings 67

Site Identifier 68

Instrument Serial # 68

Report Logo 68

LabName 68

LabAddress 69

Default Printer 69

Report Template 69

Add a Local Printer 70

Add a Network Printer 70

Delete a Printer 70

Auto Print Reports 70

Auto Print Screen Captures 71

Default Export File Type 71

Default Output Path 71

Output Path 72

LIS Settings 72

Assay Settings 75

Bay Configuration Settings 78

Disable a Bay 80

Enabling a DisabledBay 80

Data Settings 81

PerformDatabase Backup 82

Restore Database Backup 82

User Settings 84

SendUserBarcode 89

Network Settings 89

Chapter 7. Tools 92


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External Controls 92

System Events 95

Troubleshooting 96

CreatingTroubleshootingPackages 96

Maintenance 97

Cleaning the Instrument Surfaces 97

CleaningMaterials 97

Chapter 8. Reference 99

ePlex Specifications 99

Barcode Requirements 99

Chapter 9. Troubleshooting 101

Common Issues andSolutions 101

Hardware Troubleshooting 101

Error Codes 104

BayFirmwareErrorCodesandResolution 104

InstrumentSoftwareErrorCodesandResolution 106

AssaySoftwareErrorCodesandResolution 109

Chapter 10.Glossary 111

Chapter 11. Index 114


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LimitedWarranty/Limited Liability

GenMark Diagnostics warrants to the original purchaser that products will be free from defects in workmanship ormaterials for a period of one (1) year from date of purchase under normal use. The sole and exclusive remedy underthis limitedwarranty is repair or replacement of defective products or parts thereof. Repair or replacement productsor parts thereof will be furnished solely on an exchange basis and are obtainable only by the original purchaser. Theoriginal purchaser shall return the defective product, or part thereof, properly packagedwith postage or shippingcosts prepaid to GenMark Diagnostics. Loss or damage during shipment shall be at the risk of the purchaser.

This limitedwarranty does not include repair or replacement necessitated by accident, neglect, misuse, relocation,unauthorized repair, or modification of the product. The above limitedwarranty is the sole warranty provided byGenMark Diagnostics. No other warranties, expressed or implied, including warranties of merchantability or fitnessfor a particular purpose, are providedwhatsoever. GenMark Diagnostics shall have no liability for any direct,indirect, consequential, or incidental damages arising out of the use, the results of use or the inability to use theproduct. Some products may be deemed non-returnable due their biological status. Accordingly, prior to returning adefective or service-requiring product, please contact GenMark’s technical services department to evaluate andarrange a return.

Patents

eSensor® electrochemical detection technology is proprietary to GenMark Diagnostics, Inc. and, depending onspecific application and configuration, embodied in one or more of United States Patent #6,197,515, 6,322,979,6,306,584, 5,620,850, 6,472,148, 6,809,196, 5,591,578, 5,824,473, 6,177,250, 6,277,576, 6,268,149, 6,268,150,6,180,352, 6,200,761, 6,238,870, 6,258,545, 6,528,266, 5,770,369, 5,705,348, 5,780,234, 5,952,172, 6,087,100,6,071,699, 6,265,155, 6,291,188, 7,033,760, 6,096,273, 7,014,992, 6,221,583, 6,090,933, 7,045,285, 6,479,240,6,977,151, 7,125,668, 7,381,533, 7,384,749, 7,381,525, 6,232,062, 6,495,323, 7,056,669, 7,560,237, 7,601,507,7,713,711, 6,013,459, 6,013,170, 6,248,229, 7,018,523, 7,267,939, 7,514,228, 7,566,534, 7,595,153, 7,582,419,7,579,145, 6,740,518, 6,063,573, 6,600,026, 7,160,678, 7,393,645, 6,290,839, 6,264,825, 6,761,816, 7,087,148,7,655,129, 6,541,617, 6,942,771, 7,534,331, 6,432,723, 6,833,267, 7,090,804, 6,686,150, 6,753,143, 7,312,087,7,172,897, 6,753,143, 6,518,024, 6,642,046, 6,361,958, 6,960,467, 6,602,400, 6,824,669, 6,596,483, 6,875,619,foreign equivalents thereof, and a host of pending patent applications. Many of these rights, including the use ofself-assemblingmonolayer (SAM) technology, are rooted in exclusive licenses taken fromHarvardUniversity andCalifornia Institute of Technology (Caltech), and particular fields of use may be available for sublicensing.

GenMark Diagnostics, Inc. has also taken various licenses to third party technology, including, but not limited to,certain microfluidics technology fromCaliper Life Sciences Corporation and certain digital microfluidics technologyfromAdvanced Liquid Logic, Inc.

Licensing inquiries should be directed to GenMark's Legal Department at 5964 La Place Court, Carlsbad, CA92008.

Trademark andCopyright Statements

Copyright © 2017, GenMark Diagnostics. eSensor®, ePlex®, GenMark®, andGenMark Dx® are trademarks ofGenMark Diagnostics.


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IntendedUse

The ePlex® instrument is an automated in vitro diagnostic device designed to performmultiplexed nucleic acid testsfor the simultaneous detection and identification of nucleic acid targets by processing single-use cartridgesdeveloped andmanufactured by GenMark Diagnostics, Inc.


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Chapter 1. Preface

About thisManual

The ePlex system operator manual provides instructions how to operate the ePlex system. The instructions withinthis manual assume user has basic software computer skills.

How toUse thisManual

This manual is designed to offer easily accessible information about the ePlex system (also referred to as ePlex orePlex instrument in this manual), including guidelines for safety, operation andmaintenance. It is provided byGenMark Diagnostics, the manufacturer of the ePlex system, and should be controlled as laboratory equipmentdocumentation. This manual is intended for any personnel operating the ePlex system.

The information covered in this manual is a supplement to the ePlex training delivered by GenMark Diagnostics or aGenMark authorized representative. It will serve as an instructional guide during the training process and then as aconvenient reference for future use and training.

Information in this manual is subject to change without notice. No part of this documentmay be reproduced ortransmitted in any form, for any purpose, without the written permission of GenMark Diagnostics.

Note: Reading this manual alone does not automatically authorize or certify a person to operate ePlex.

This manual consists of the followingmain chapters:

l Chapter 1: Preface – A description of how to use this manual and Technical Support contacts.

l Chapter 2: Compliance andSafety – A list of safety-relatedwarnings, precautions, and limitations to observewhen setting up and using ePlex.

l Chapter 3: SystemOverview – A physical description of the ePlex, including instrument and componentspecifications and also a description of ePlex operation.

l Chapter 4: Using the System – Step-by-step instructions for getting started and completing runs.

l Chapter 5: Reports – Descriptions and instructions for generating and viewing available reports.

l Chapter 6: Settings – Instructions on ePlex setup and configuration settings.

l Chapter 7: Tools – Instructions on predefining external controls, viewing system events and generatingtroubleshooting packages.

l Chapter 8: Reference – Instructions on viewing on-screen help content and ePlex specifications.

l Chapter 9: Troubleshooting –Guidance for troubleshooting ePlex issues.

GettingHelp

For any questions concerning how to set up, use, or maintain ePlex that are not covered in this manual, refer to thefollowing available resources:

l ePlex help – Can by accessed from the ePlex user interface by selecting the Help icon on thetoolbar


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l Package Insert – Information specific to the preparation and performance of each assay is located athttps://www.genmarkdx.com/CustomerResources

If you are in the United States, contact GenMark Technical Support for additional assistance, questions, or issuesconcerning ePlex. For inquiries or concerns outside the United States, contact GenMark Technical Support or yourauthorizedGenMark representative.

Before contacting GenMark Technical Support please have the following information:

1. Last four digits of the ePlex Serial Number

2. Error Messages (if applicable)

United States

Contact GenMark Technical Support at:

1-800-373-6767, Option 2

[email protected]

International

Contact GenMark Technical Support at:

+41 41 229 42 60

[email protected]

Additionally, the Troubleshooting chapter at the end of this manual offers insight into troubleshooting system issues.


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https://www.genmarkdx.com/CustomerResources

mailto:[email protected]


ePlexManufacturer

GenMark Diagnostics, Inc.5964 La Place CourtCarlsbad, CA 92008USA

Phone: 1.760.448.4300Fax: [email protected]

Corporate Headquarters

GenMark's corporate headquarters is located in North America.

GenMark Diagnostics, Inc.5964 La Place CourtCarlsbad, CA 92008USA

Phone: 760.448.4300Fax: [email protected]

International Locations

GenMark Diagnostics Europe GmbHGeneral-Guisan-Strasse 66303 ZugSwitzerland12A

Phone: +41 41 229 42 [email protected]

AuthorizedRepresentative

In Europe, GenMark's authorized representative is Emergo Europe

Emergo EuropePrinsessegracht 202514 AP The HagueThe Netherlands

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Phone: +31 (0)70 345 8570Fax +31 (0)70 346 7299

Other Locations

Contact information for GenMark offices is available on our website at:

http://www.genmarkdx.com


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http://www.genmarkdx.com/

Chapter 2. Compliance and Safety

GeneralSafety Precautions

Before operating the ePlex system, make sure you read this operator manual entirely and ensure you are familiarwith the safety information. Operating the ePlex system outside the procedures specified in this manual can result inexposure to hazards that can cause injury to personnel, damage the system, or adversely impact systemperformance.

Safety Symbols

Sections markedwith safety symbols contain important safety information for optimal operation of the ePlex system.Attention to these advisories may prevent harm to operator, damage to the system, or compromised test results.

Warning: A hazard or operational warning. Not following the specified directions or guidelines could result inharm to the operator, damage to the system, or compromised test results. Indicates a possibility of adversereactions, injury, or death to the user or other personnel if the precautions or instructions are not observed.

Electrical Warning: A hazard or operational warning. Not following the specified directions or guidelinescould result in harm to the operator including electric shock.

BiohazardWarning: A hazard or operational warning. Not following the specified directions or guidelinescould result in harm to the operator including exposure to biohazardousmaterial.

Note: A note identifies important details that apply to specific cases or tasks.

Additional symbols may be used on the ePlex test kits and are explained in the associated Package Insert.

SymbolsUsed in theManual and on ePlex Instrument Labels

In vitro diagnostic medical device European Union Conformity

ManufacturerAuthorized representative inthe European Community

Serial number Catalog number

Consult instructions for use WEEE - Do not throw in trash

RoHSDirective ETL ListedMark


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Caution Biological Risk

Electrical Risk Note

On Off

Compliance

The ePlex system has been tested according to the following directives:

Electromagnetic Compatibility (EMC)

l CISPR 11:2015

l IEC EN 61326-2-6:2013

Standards

l EN 61010-1:2004

l EN 61010-2-101:2002

l CAN/CSA-C22.2 NO. 61010-1-12

l EN ISO 134875:2003

l EN ISO 14971:2012

l EN ISO 15223-1:2012

Warnings andHazards

Follow standard laboratory precautions when operating the ePlex system. The warnings listed in this section applyto the ePlex system and its accessories.

GenMark Incorporated does not take any responsibility for unauthorizedmodifications to the ePlex system or forfailure of operating personnel to heed the warnings and cautions. Any equipment used in a manner not specified inthis manual may become unsafe. Review all warnings in this section before operating the ePlex system.

SystemHandlingWarnings

l The ePlex systemmust be assembled, installed, and qualified by GenMark authorized personnel.

l Do notmodify the ePlex system hardware or software without written authorization fromGenMark or aGenMark authorized representative.

l Do not add or connect any accessories to ePlex without authorization fromGenMark or a GenMarkauthorized representative.

l Do not attempt repairs or service on ePlex or accessories without authorization fromGenMark or a GenMarkauthorized representative.


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l In the event of an observed leak, contact GenMark Technical Support.

l Follow all written and on-screen instructions for safe and effective use of the ePlex system.

l Only properly trained personnel should operate and perform any repair or service on the ePlex system.

l Do not remove any covers or panels without authorization fromGenMark or a GenMark authorizedrepresentative.

l For routine surface cleaning, do not spray any fluids directly on the ePlex system, accessories orcomponents.

l Do not shut off main power to the ePlex systemwhile the system is starting or running. Please use the ePlexsoftware to properly shutdown or restart ePlex.

l Use only GenMark approved cartridges on the ePlex system.

l Always backup current database prior to restoring a new database or purging data.

l Do not attempt to reuse ePlex cartridges.

l Avoid pressing down on the top label of the cartridge prior to running the cartridge.

l When manually starting a run, ensure accession ID is accurate.

l In the case of a software downgrade, data generatedwith the newer software may be lost after downgrading.Backup database prior to downgrade.

l Restoring a database may result in lost data on the currently installed database. Ensure you backup thecurrent database before restoring the database.

l Do not attempt to lift or move the ePlex systemwithout authorization fromGenMark or a GenMark authorizedrepresentative.

l See original equipmentmanufacturers instructions for safe operation of ePlex accessories.

Environmental Warnings

l Do not operate the ePlex system outside of the required environmental specifications.

l Do not operate the ePlex system above elevations of 2000meters (6,700 feet).

l Prior to preparing an ePlex run, clean all work surfaces with appropriate cleaning solution.

l Do not use the ePlex in close proximity to sources of strong electromagnetic radiation as these devices mayinterfere with ePlex operation.

l Ensure at least 7.62cm (3") clearance around and on top of the ePlex system for adequate ventilation andcooling.

CartridgeHandlingWarnings

l Avoid touching the transfer device's tip. Follow assay specific Package Insert.

l Do not place accession ID barcode outside of the designated barcode placement area on the ePlexcartridge.

l Inspect all ePlex cartridges for damage prior to use.

l Do not insert an ePlex cartridge if the cartridge has any signs of leaks or fluid.


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l Do not invert ePlex cartridges after dispensing sample into sample port.

l Avoid touching inside the sample port on the ePlex cartridge.

l Do not attempt to reopen the sample cap on the ePlex cartridge after closing the cap.

l Always handle samples cautiously and keep all samples upright to prevent splashing or spilling.

Biological Hazards

l Follow universal precautions for biohazards when handling all samples andwhen performing all maintenanceactivities.

l Wear safety equipment or apparel, including gloves, safety glasses, and lab coats when working with patientsamples.

l Complete sample transfer in a biosafety hood.

l Treat all samples and controls as potentially infectious material.

l Dispose of processed ePlex cartridges as biohazardous waste upon removal from ePlex.

l Do not attempt to open or disassemble ePlex cartridges at any time.

l Leaks from the ePlex system or cartridges may contain biohazardousmaterials.

l Consult biological hazards listed in the ePlex assay Package Insert.

Electrical Hazards

l Never touch any switches or outlets with wet hands or wet gloves.

l Never disconnect power connections to ePlex while running.

l Perform only maintenance and service procedures in this manual or authorized by GenMark or a GenMarkauthorized representative.

l Do not operate the ePlex system if any liquid has leaked inside or on the ePlex system or cartridge.

l Shutdown ePlex software before turning off front power button or main power switch.

l Turn off the power using both the front power button and rear power switch before disconnecting the ACpower cord.

l Do not place open liquid contains on or around the ePlex system.

l Do not insert anything other than the ePlex cartridge or test cartridge into the bay slot on the ePlex tower.

GloveUsage

Gloves provide a necessary protective barrier when handling potentially infectious substances. Changing glovesafter contact with samples prior to operating ePlex helps to prevent transmission of contaminants to the ePlexsystem. As a precautionary measure, gloves should be worn while operating the ePlex system. Please follow therecommended glove changing guidelines below.


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Change gloves before:

l Loading cartridges into ePlex

l Completing any service or maintenance procedures

l Transfer of sample into ePlex cartridge

Change gloves after:

l Cleaning work surfaces or handling cleaning solution

l Coming in contact with sample or areas exposed to sample

l Transferring sample into ePlex cartridge

l Any signs of fluid on gloves

l Completing any service or maintenance procedures

In general, change gloves periodically in accordance with laboratory guidelines.


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Chapter 3. SystemOverviewThe GenMark ePlex system (2 tower configuration) is depicted below. The touchscreen graphical user interface(GUI) is flanked on either side by a tower with six bays containing a slot for the cartridge and an LED to indicate baystatus. The instrument is designed to be scalable with configurations to accommodate a single tower with 6 bays orup to four towers with 24 bays.

The ePlex system is used to run multiplex microarray-based assays developed by GenMark. This type of assay isbased on the principles of competitive nucleic acid hybridization using a sandwich assay format, wherein a single-stranded target binds concurrently to a sequence-specific solution-phase signal probe and a solid-phase electrode-bound capture probe. The test employs nucleic acid extraction, target amplification via polymerase chain reaction(PCR) or reverse transcription PCR (RT-PCR) and hybridization of target DNA. In the process, the double-strandedPCR amplicons are digestedwith exonuclease to generate single-strandedDNA suitable for hybridization.

Nucleic acid extraction from biological samples occurs within the cartridge via cell lysis, nucleic acid capture ontomagnetic beads and release for amplification. Amajority of the nucleic acid extraction is processed throughtraditional microfluidic liquid handling. Once the nucleic acid targets are captured and inhibitors are washed away,the magnetic particles are delivered to the electrowetting environment on the printed circuit board (PCB) and thetargets are eluted from the particles and amplified.

During hybridization, the single-stranded target DNA binds to a complementary, single-stranded capture probeimmobilized on the working gold electrode surface. Single-stranded signal probes (labeledwith electrochemicallyactive ferrocenes) bind to specific target sequence / region adjacent to the capture probe. Simultaneoushybridization of target to signal probes and capture probe is detected by alternating current voltammetry (ACV).Each working electrode on the array contains specific capture probes, and sequential analysis of each electrodeallows detection of multiple analyte targets.

DigitalMicrofluidics: ElectrowettingTechnology

GenMark processes the nucleic acid amplification reactions usingmicrofluidics. Because of the discrete nature ofthe liquid volumes as well as the synchronization and programmability of the fluidmanipulations, this technique hasbeen referred to as digital microfluidics. Digital microfluidics uses electrical fields to directly manipulate discretedroplets on the surface of a PCB. The movement of discrete droplets in a programmable fashion with electricalfields is referred to as the electrowetting effect. Electrowetting is facilitated by the activation of an electrode


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resulting in a local reduction of the interfacial tension between the droplet and the surface to drive fluidmovement toadjacent electrodes (as shown in the figure below). An array of surface electrodes is opposed by another plate toform a chamber in which the samples and reagents are sandwiched. The remaining space is filledwith animmiscible filler fluid to prevent evaporation of the droplets and to facilitate droplet transport. Droplets can betransferred between any neighboring electrodes and can be transported anywhere within a network of contiguouselectrodes. In addition to transport, other operations such as merging, splitting, dispensing andmixing of dropletscan be performed using the same principles.

The PCB contains electrodes for target elution andmixing with a center channel to move extracted nucleic acid tomix with reagents for PCR (see figure below). Thermalcycling is performed on up to four narrow electrode lanes witheach lane handling up to two separate PCR reactions, for a total of up to eight PCR reactions per PCB. After PCR,the fluid is moved back to the reagentmixing area before introduction to one or all of the eSensor grids dependingon the assay.

.

eSensor Technology

Detection of analyte targets is accomplished using eSensor technology. eSensor technology uses a solid-phaseelectrochemical method for determining the presence of one or more nucleic acid target sequences with the abilityto identify target organisms in an amplified nucleic acid sample (see figure below). eSensor detection consists of aset of electrodes with each containing a unique synthetic oligonucleotide capture probe that is complementary tosingle-stranded target DNA fragments generated during PCR and exonuclease treatment. The single-strandedtargets hybridize to complementary sequences of ferrocene-labeled signal probes, which in turn hybridize tocomplementary sequence of the capture probes. The presence of each target is determined by voltammetry.Binding of nucleic acidwith the capture probe and signal probe brings the ferrocene label in close proximity to thegold electrode. An electric signal specific to the hybridized complex is generated as a byproduct of a reduction-oxidation reaction when a current is applied. The ePlex systemmeasures (nanoamps) and interprets this electricaloutput to determine the target status.


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Components

The GenMark ePlex instrument is designed to process molecular diagnostic tests in a moderate complexity labenvironment. The GenMark ePlex instrument consists of three main components:

l Base: A touchscreen graphical user interface (GUI) powered by a PCwith a Windows Operating System. Thebase communicates with the bays to transfer data. The instrument software installed on the ePlex baseprocesses the raw data generated by the individual bays and determines the test result.

l Tower: A chassis housing six bays. ePlex is scalable from one to four towers connected to either side of thebase.

l Bay: 6 bays are housed in each tower. Each bay will accept cartridges independent of the testing status ofthe other bays allowing for random access testing. Each bay has an Ethernet port for communication with thebase unit to receive user inputs and deliver test data to the ePlex instrument software.

Amore detailed description of these components is provided in this section.


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ePlex provides random and continuous access tomaximize sample processing efficiency. Assay reagents areintegratedwithin the cartridges which are processed in the individual bays. Although the cartridges use a standardtemplate, the assay specific parameters and reagents are self-containedwithin each cartridge. Therefore, eachcartridge represents an independent assay run.

The GenMark ePlex instrument does not require typical fluidic-based components and thus removes the need foruser interaction tomaintain these components as required by other systems. The user interaction is limited to theGUI, the cartridge, and loading/unloading the cartridge in the bay.

Base

The primary user interaction with GenMark’s ePlex instrument is driven by the touchscreen GUI within the base unit.The ePlex instrument software allows the user to intuitively interact with the touchscreen to run tests, view reports,andmanage data. The Run view displays the status of each bay and is the primary screen for interacting with theinstrument to process tests. Upon completion of a run, the software automatically generates a Detection Reportwith easy viewing access.


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The Run view displays a Bay icon for each cartridge bay. Each cartridge Bay icon will display information such asthe accession ID, the test type, the time remaining, and current progress. Selecting a Bay icon will open a moredetailed view of the bay information to accommodate comments, patient ID, additional test and bay information, andother operations. The GUI will offer additional screens tomanage reports, system tools and settings. The basecontrols each tower and bay, provides power, and stores and analyzes data. The instrument is designed to beoperated solely with the touchscreen interface. Entering patient accession IDs can be performed using the barcodescanner or the on-screen keyboard.

Tower

The tower contains 6 individual cartridge bays (see figure below), network hub and cooling components. Up to 4towers can be attached to a single ePlex base. This provides scalability and allows the instrument to independentlyrun 1 to 24 assays concurrently.

Bay

Each bay is an individual unit that contains the following:

• Electronics to control all bay functions and a series of electrical connections to interact with the cartridge

•Mechanical actuation of cartridge and its on-board reagents

• Peristaltic air pumpmoves sample into the cartridge

•Mechanical actuation of mixing paddle to effect bulk sample mixing during nucleic acid extraction


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•Magnets to facilitate magnetic bead capture during nucleic acid extraction

• Heaters and a thermoelectric peltier cooler to provide heating and cooling zones for PCR and incubation

Each bay contains the hardware and firmware necessary tomove droplets on the cartridge per a predefined assayprotocol. It also contains preliminary data analysis (i.e. data acquisition and signal processing), liquid handling,detection, and heating capabilities. The cartridge bay never comes in contact with fluid and the entire assay iscontrolled through electrical, mechanical, and pneumatic connections between the bay and cartridge. The baycontains the heaters and peltier element for incubation andPCR thermalcycling.

The bays operate independently of each other. Multiple cartridges can be loaded at one time into separate bays,and the remaining bays are available for use while the instrument is running. Each bay processes tests using on-board firmware minimizing the amount of communication to and from the base allowing the bays to continueprocessing tests even if communication to the base is lost or software needs to be restarted.

CartridgeThe ePlex cartridge consists of a specifically designed array of printed circuit board (PCB) surface electrodesenclosed in a chamber which is packaged in a plastic device. The cartridge chamber is filledwith an immiscible fluidto isolate droplets and facilitate transport of the sample and reagent droplets.

The top of the cartridge PCB contains electrode traces for target elution andmixing, reagent storage andmixing,PCR thermalcycling, and eSensor detection. The eSensor detection zones consist of an array of gold-platedelectrodes. Each eSensor electrode is modifiedwith a multi-component self-assembledmonolayer that includesoligonucleotide capture probes specific for each target site on the test panel and insulator molecules. The bottom ofthe cartridge PCB contains banks of electrodes to facilitate electrical connection to the instrument cartridge bay. Inthe reagent storage area, reagents are dried down and reconstitutedwhen droplets are moved over the dried downarea. Wet reagents are stored in blister packs above the PCB and released into the cartridge chamber throughactuation by bay mechanisms. The cartridge enclosure provides packaging for the PCB and the sample port.


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The cartridge PCB contains an Electrically Erasable Programmable Read-Only Memory (EEPROM) chipwhichcontains cartridge information including the cartridge ID, lot number, expiration date, and test protocol. TheEEPROM is programmed as "used" by the bay when a test is started to prevent reuse of cartridges.

AccessoriesUninterruptible Power Supply (UPS) is a optional component used to ensure ePlex can safely shutdown in the eventof a power outage. The GenMark suppliedUPS can maintain power to ePlex for at least 5minutes. Total UPSbattery backup time is dependent on both configuration of the ePlex and the state of each individual bay. The UPS isconfigured to alert ePlex to safely shutdown when the UPS battery threshold is met.

GenMark supplies an optional printer for use with ePlex. Inkjet and laserjet printers are available fromGenMark forprinting reports and screen captures as needed.

Operation

The workflow for processing a cartridge on the ePlex system includes the following:

1. Apply an accession ID barcode to the cartridge matching the accession barcode on the primary sample.

Note: Ensure both barcodesmatch prior to transferring sample.

2. Transfer sample into the sample port on the cartridge in accordance with the associated test panel PackageInsert.

Note: Sample cap is clear enabling user to confirm sample was added to the cartridge after closing thecap.

3. Rotate cap 90° clockwise and close the cap to seal the cartridge.


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4. Scan the cartridge barcodes. Upon successful scan of both the cartridge ID barcode and the accession IDbarcode the scanner will beep once and LED on the scanner will blink green indicating a successful scan.

5. Insert cartridge into any ready bay indicated by a blinking white LED. The systemwill match the accession IDto that bay and automatically starts the run.

6. Upon run completion, the bay will automatically eject the cartridge and prepare the Detection Report fordisplay, print, or export using View Sample Report on the Bay icon or Bay Details view.


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7. Select View Sample Report to view the Detection Report.

Navigating the User Interface

The ePlex user interface is organized into four main views: Run, Reports, Settings and Tools. The default view is the

Run view. Tomove from one screen to the next, select the Navigation icon in the lower left hand corner

of the toolbar and choose the desired view from the menu.

The toolbar is visible at the bottom of the screen in all screen views. The toolbar includes:


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1. Navigation icon

2. Pending Test Orders icon

3. Manual Entry icon

4. Remote icon

5. Help icon

6. Screen Capture icon

7. Current User icon

8. Logout icon

9. Current Date/Time

10. Restart icon

When applicable, toolbar will include:

11. Bay Errors icon

12. Alerts icon


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Help Screen

To access the ePlex operator manual on the Help screen, select the Help icon on the toolbar from anyview. To exit the Help screen select the Help icon again.

Use the instructions in the manual for assistance or troubleshooting purposes.

UpdatingHelpContent

When necessary, GenMark Service Personnel and Supervisor users can update the on-screen help content. Whenan update is required, GenMark or an authorizedGenMark Service Personnel will send an update directly to thelaboratory where it can then be imported into ePlex.

ScreenCapture

Use the Screen Capture icon on the toolbar of any view to capture the entire contents of the screen inan image file. If the on-screen keyboard is visible, use the Screen Capture icon located in the upper left hand corner


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of the on-screen keyboard.

Note: There will be a visual and audio indication each time a screen capture is successfully performed.

Screen captures are saved in a folder on the local drive and can be included in troubleshooting packages.

LoggingOut and ShuttingDown

ePlex allows for only one user to be logged in at one time.

Note: ePlex will automatically logout users at time intervals determined by the Supervisor.

Logout

1. To log off ePlex, select the Logout icon on the toolbar.

Restart

1. To restart ePlex software, select the Restart icon on the toolbar.

Note: Restarting ePlex software will not impact runs currently processing. Communication and rundata will be re-established after restart.

Shutdown

1. To shutdown the ePlex, select the Current User icon or the Logout iconon the toolbar.

2. Select Shutdown.


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3. Select Yes.

RunView

The Run view displays all towers and all bays that are currently configured. Each Bay icon displays the bay location,status indication, and if applicable, the Accession ID, Assay name andAssay version, estimated time remaining andprogress bar. Selecting a bay will provide additional information via the Bay Details view.


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Note: The layout of the Run view will vary depending on the number of towers configured .

Outstanding Accession ID View

Either upon scanning both Accession ID and cartridge ID barcodes or manually starting a test, the user will beprompted to insert the cartridge into a ready bay. This is called the Outstanding Accession ID view.

There is only one outstanding accession ID allowed, and the run may be canceled before cartridge is loaded into abay. Workflow on ePlex requires operator to scan and then load cartridge prior to scanning another cartridge.


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BayDetails View

The Bay Details view displays the following information for each bay:

Note: Not all elements are applicable if a run is not in progress.

1. Bay Location

2. Bay Serial Number

3. Accession ID

4. Assay Name

5. Comments

6. Error andWarningmessage(s) associated to the bay or current test with visual Indication for each item (notshown)

7. Patient ID

8. Cartridge Serial Number / Cartridge ID

9. Cartridge Lot Number

10. Estimated Time Remaining (HH:MM)

11. Cartridge Expiration Date

12. Instructional message(s) (not shown)


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13. Run Operator

14. Progress bar of time remaining

Note: If less than 1minute remains, the process bar will show 00:01.

If there is a run in progress, the user can enter and edit the sample comments, assign or edit a patient ID, and editthe Accession ID from the bay details view.

Note: The Accession ID is only editable if the operator started the run via Manual Entry.

From the Bay Details view, a user may abort a run in progress by selecting Abort .

A user may view the Detection Report when the bay is in the Run Complete state from both the Bay Details view andthe Bay icon until the cartridge is removed by the user.

Note: All Detection Reports are also accessible on the Reports > Sample Results tab.


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Chapter 4. Using the System

User Roles andRights

There are two user roles for ePlex: Operator and Supervisor. Supervisor users have administrative rights which givethem access to additional options for configuring ePlex, customizing reports, creating user accounts, running bayqualification tests, performing backups, and updating ePlex software.

Right Operator Role Supervisor Role

Performasample test

Electronically signasrunoperator

Filter/View/Print/Export reports

Use screencapture feature

Use remote access

Viewhelp file

Import test ordersvia file

Managependingtest orders

Abort a sample test

View, define, edit detailsofanexternalcontrol

Edit Sample data (Accession ID, Patient ID, Comments)

PerformPOSTonabay

Create troubleshootingpackage

Send their ownuserbarcode

Enable/Disable abay

Send results toLIS

Export bayconfiguration report

Restart software

Reset a bay

Viewsystemevents

Set systemconfigurationsettings

Create/EditOperatorand Supervisoraccounts

Edit usermanagement settings

Performdatabasebackup


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Right Operator Role Supervisor Role

Performdatabase restore

Performdatabasepurge

PerformePlexsoftware upgrade/downgrade

Installnewhelpmaterial

Send otheruserbarcodes

Electronically signasApproverof reports

Define reportable target groupsperassay

Performbay replacement procedure

Install firmware version toselected bays

Define externalcontrol frequency, lot and validity requirementssettings

Require valid externalcontrols toperform tests

Power on the System

To turn on ePlex:

1. Ensure the main power switch is in the "On" position indicated by "I" The main power switch controls power tothe entire ePlex System.

2. Press the power button on front of the base to illuminate the switch and turn ePlex on. The front power switchcontrols power to the ePlex integrated PC.


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Note: If ePlex does not turn on, check the main power switch in the back left corner of the Instrument.

Electrical Warning: Once the instrument is running, the main power switch in the back left corner of thebase will shut down ePlex immediately. All samples running at the time of shutdown will be lost.

Electrical Warning: Turn off the power using the front power button before disconnecting the AC powercord.

Electrical Warning: Never touch any switches or outlets with wet hands or wet gloves.

Electrical Warning: Perform only maintenance and service procedures in this manual or authorized byGenMark or a GenMark authorized representative.

Electrical Warning: Do not operate the ePlex system if any liquid could have leaked inside or on the ePlexsystem or cartridge.

Electrical Warning: Turn off the power using the front power button before disconnecting the AC powercord.

Electrical Warning: Do not place open liquid contains on or around the ePlex system.

Electrical Warning: Do not insert anything other than the ePlex cartridge or test cartridge into the bay slot onthe ePlex tower.


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Logging In

To login ePlex:1. Select the username text box.

2. Enter the username and select Enter (alternatively, select the username from the drop-down list).

3. Select the password text box.

4. Enter the password and select Enter.

The software will open in the Run view.

OR

When using the barcode scanner, simply scan the user barcode of an active user and you will be logged in and thesoftware will go to the Run view.

A sample user barcode:

Note: Username and password are encryptedwithin the user barcode.

Note: Any user can login at any given time without interrupting ongoing runs. ePlex does not allow forconcurrent user logins.

Using the Touchscreen

The ePlex graphical user interface allows users to easily navigate through the software simply by touching thescreen.

The following guidelines apply when using the touchscreen:

l Touch buttons, text boxes and field headings only once; there is no need to double-touch anywhere on theePlex interface.

l Touch delay may occur on certain screens including the Bay Configuration screen as ePlex is gatheringinformation from the bays.


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l After selecting certain functions you may see the Loading icon please be patient as ePlex isprocessing the request.

l The followingmulti-touch gestures are enabledwhen viewing reports:

l Pan Up

l Pan Down

l Pan Left

l Pan Right

l Zoom In

l ZoomOut

l To enter information into a specific field, first highlight that field by selecting within the text box. The on-screenkeyboardwill appear, allowing users to begin entering text. Select Enter when complete.

l Select the SHIFT key to display symbols in place of the numbers on the on-screen keyboard.

l To hide the on-screen keyboard, touch the blue X in the upper right hand corner of the keyboard, touchoutside the keyboard or select Esc to hide the keyboard.


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PreparingCartridges

Prepare cartridges according to the procedures detailed in the associated ePlex Panel Package Insert located athttps://www.genmarkdx.com/CustomerResources

The following sections in this manual assume that each cartridge has been properly loaded in compliance withlaboratory standards and safety protocols.

Before inserting the cartridges into ePlex, check that they are properly labeled, cap is closed completely andconfirm the accession ID barcode on each sample tube and cartridge match.

Startinga Run

A user can start a run by any of the followingmethods:

1. Manual Entry

2. Barcode Scanner

3. Pending Test Orders (PTO) Manual Run

Manual Entry

1. Go to the Run view.

2. Select the Manual Entry icon from the toolbar.

3. Enter an accession ID using the on-screen keyboard or barcode scanner and select Enter.

4. Insert the cartridge into any ready bay with a blinking white LED.

Note: Positive sample identification (pos-ID) is not valid using the Manual Entry workflow. A flag will be notedon the Detection Report stating "Manual start of a sample test" if using the Manual Entry workflow.

Note: Ensure manually entered accession ID is accurate before starting test.


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http://www.genmarkdx.com/customer_resources.php

BarcodeScanner


2. Scan the cartridge by holding it under the barcode scanner.

Note: Both the customer applied accession ID barcode and the cartridge ID barcode are required for asuccessful cartridge scan. Scanner will beep once and LED on the scanner will blink green uponsuccessful scan of both barcodes.


Note: Using the barcode scanner is the recommendedworkflow on ePlex as it maintains positive sampleidentification.

Note: If downloading test orders, upon scanning an accession ID, ePlex will check for a matching pendingtest order and start the run.

Pending Test Orders (PTO) Manual Run


2. Select the Pending Test Orders icon from the toolbar.

3. Select an available pending test order from the list.

4. Select Run.


6. Note: Positive sample identification is not valid using the PTOmanual workflow. A flag will be noted onthe Detection Report stating "Manual start of a sample test" if using the PTOmanual workflow.

Using the Barcode Scanner

The barcode scanner can be used to complete the following activities:

1. Log in with a User barcode .

2. While on the Run view, the barcode scanner will simultaneously read the accession ID barcode and cartridgeID barcode from a cartridge to start a run.

Note: To start a run using the barcode scanner workflow, user must be on the Run view.

3. External control barcodes can be generated by the software and scannedwith the barcode scanner whenrunning external controls on ePlex.


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4. After selecting the Manual Entry icon , the barcode scanner can be used to enter the AccessionID (while the on-screen keyboard is visible).

5. User barcodes can be used to electronically sign a report.

6. While on the Reports > Sample Results tab, the barcode scanner can be used to enter an accession ID in the

search field .

Barcode ScanningTips

For effective barcode scanning follow these guidelines:

l Ensure room has adequate ambient lighting.

l Hold the ePlex cartridge in handwithout covering any barcodes.

l Maintain at least a cartridge length between the bottom of the scanner and the cartridge.

l Move cartridge in a horizontal position with arrows pointing to the back of ePlex aiming the red crosshairs forthe scan location shown below.


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Note: If ePlex cannot successfully scan barcodes, refer to starting a run usingmanual entry.

InsertingCartridges intoePlex

Once ePlex has the information needed to start a run, the user interface will instruct the user to enter the cartridgeinto any ready bay indicated by blinking white LEDs.

Insert the cartridge with the label facing up and arrows facing the bay as shown below.


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PendingTest Orders

If LIS communication is enabled, ePlex will import test orders sent from the LIS System. The successfullydownloaded LIS test orders will be displayed in the Pending Test Order list.

Pending Test Orders can also be manual imported using Import.

A new entry will be created for any non-duplicate entries in the Pending Test Order list. Duplicate entries receivedfrom the LIS host will be ignored.

Note: Duplicate entry indicates matching an existing accession ID and assay. If the sample is currentlyrunning or completed, a new entry will be created; the matching is only against the current Pending TestOrder items.

ePlex allows the LIS host to cancel a test order that is still in the Pending Test Order list.


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ManagingPendingTest Orders

Test orders can be automatically sent from an LIS or manually imported into the Pending Test Orders list.

The Pending Test Orders list can be viewed from the Run view by selecting the Pending Test Orders icon

and includes the following elements:

1. Accession ID

2. Assay

3. Date/Time of Test Order Entry (into the system)

4. Bay Location, if the sample is currently in-progress

5. Search Accession ID box

6. Import button

7. Delete button

8. Run button

If a sample test was run and produced an invalid result, the test order entry in the list will be italic and red. ThePending Test Orders list can be searched by accession ID. Users can manually delete from the Pending Test Orderslist if the test order is not currently in-progress. A test order may be marked as canceled if the test order has notbeen started.

Note: All other requests to cancel a test order will be ignored.


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A test order is automatically deleted from the Pending Test Order list upon run completion with valid results.

Manual Importing of Pending Test Orders

1. Go to Run view.

2. Select the Pending Test Orders icon on the toolbar.

3. Select Import.

4. Use the file browser to select the pending test order file(s) and select Select.

5. Select OK.

Search Pending Test Orders

1. Go to Run view.


3. Select the Search text field.

4. Enter the accession ID of an existing pending test order and Enter.

Note: Accession IDs can be entered by on-screen keyboard or barcode scanner.

Delete Pending Test Orders



3. Select the pending test order and select Delete.

4. Select Yes.

Color Status Indicators

Both the Bay icon and the bay LEDs on the physical bays will have the followingmatching color status indicators foreach state.

Color LED Activity Status

White Solid Ready

White Blinking InsertCartridge

Blue Solid Running

Green Blinking RunComplete

Red UrgentBlinking Error


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Color LED Activity Status

Red Blinking OQRequired

Off N/A Disabled

Note: A blinking LED indicates a user action is required.

Monitoring the Run

The Run view displays the Bay icons with colors matching the physical bay LEDs.

Selecting the Bay icon with a running bay will open the Bay Details view, which contains additional information forthe bay and test cartridge.

Entering/Editing Accession ID, Patient ID, andComments

While the run is in progress, the user may enter or edit the Accession ID, Patient ID, andComments from the BayDetails view.

Note: Edits can only be made while the run is in progress andmust be saved before the run completes.

1. Select a Bay icon that is running to display the Bay Details view.

2. Select the Accession ID text box.


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Note: The accession IDmay only be edited if the run was starting with a Manual Entry workflow.

3. Edit the Accession ID and select Enter.

4. Select the Patient ID text box.

5. Add or edit the Patient ID and select Enter.

6. Select the Comments text box.

7. Add or edit the comments and select Enter.

8. Select Save.

9. Select Close.

BayErrors

The Bay Error icon is visible in the toolbar of any screen of the user interface if any bay is in the errorstate.

Selecting the Bay Error icon displays the Bay Error Summary view and includes bay location, date/time of the errorand bay error message(s).


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Bay errors can cause invalid tests and should be reported to GenMark Technical Support.

Alert Notifications

The Alert icon is visible on the toolbar if there are any outstanding warning alerts that have not beenviewed. Awarning alert is used to notify a user of a systemwarning.

The Alert icon will display the Tools > System Events screen displaying all alerts andwill contain a numeric code andinformational message.

Alert notifications are informational alerts that will not invalidate a test and do not need to be reported to GenMarkTechnical Support.

Abortinga Run


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UserAborted Run1. Select the Bay icon in a running state to display the Bay Details view.

2. Select Abort.

3. Enter optional comments and select Abort.

Note: A Detection Report will be createdwith invalid results with a message indicating the test was aborted byuser.

Note: If run is aborted, the aborted test cartridge cannot be run again on ePlex.

Cartridge Removal

Upon test completion, the bay status LEDs will blink green on both the Bay icon and the physical bay. The user mayremove the used cartridge and promptly discard it according to laboratory biological waste disposal procedures.Used cartridges cannot be re-used and should be disposed of immediately unless instructed by GenMarkpersonnel.

Note: Upon removal of used cartridges, do not turn cartridges upside down .

Note: If cartridge does not properly eject after run completes press cartridge in and release. If cartridge stilldoes not eject, contact Technical Support.

Generatingand ViewingReports

To view a Detection Report for a sample that was run on a particular bay, select the green View Sample Reportbutton on the Bay icon or Bay Details view.


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Detection Reports can also be viewed from the Reports > Sample Results tab.


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Chapter 5. ReportsThe following reports are available on ePlex:

l Detection Report - Report with results for a single sample

l External Control Report - Report with results for a predefined external control

l Results Summary Report - Report summarizing data for a combination of samples

l User Access Report - Report showing the status of all user accounts

l SystemManifest Report - Report showing the configuration for the ePlex system

DetectionReport

ADetection Report is created for each sample and contains results, run and cartridge specific information.


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Saved Filters

The Sample Results tab has the option to save a set of filter criterion as a named filter. Once they are saved, thesefilters may be retrieved by using the drop-down list. The default is Recent Samples. Saved filters can also bedeleted.

The user may save a set of filter criteria for the Sample Results Report as a named filter.To create and save a filter:

1. Go to Reports > Sample Results.

2. Select the search criteria for the desired filter.

3. Select Save under Saved Filters.

4. Enter a name for the filter and Enter.

5. Select Save .

SearchAccession IDTo find a particular accession ID, use the Search box in the upper right hand corner of the screen.


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SearchFilters

Results-based reports may be filtered using the following criteria:

l Date

l Accession ID

l Assay Name

l Operator

l Bay Location

l Bay Serial

l Cartridge Lot

l Sample Typel Sample

l Control

l LIS Statusl Not Released

l Released

l Overall Resultl Detected

l Not Detected

l Invalid

l SignedStatusl Signed

l Not Signed


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l ApprovedStatusl Approved

l Not Approved

ViewReportThe selected report(s) can be viewed in PDF format. Multiple reports can be selected and opened at once using thecheck boxes next to the accession ID.

PrintThis will print the visible report to the configured printer.

ExportThis will export the selected report to the configured export output directory as the configured export file type.

Export AsThis will allow the user to select the export path and file type of the export.

Export DataRaw data may be requested by GenMark Technical Support and can be exported to the selected raw data exportpath (all selected results).

Send to LISUsers may transmit the sample result to an LIS by selecting Send to LIS.


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Note: Send to LISmay be disabled if LIS communications is disabled in Settings > LIS or the Detection Reporthas not been approved (assuming Approval required for manual release is checked).

SignOnly the Operator that started the run may electronically sign as the operator for Detection Reports.

The run Operator must either enter their username and password or scan their user barcode to electronically sign areport.

Note: Operators must have an electronic signature on file to electronically sign reports.

ApproveSupervisor users may electronically sign as the approver of Detection Reports. The Supervisor must either entertheir username and password or scan their user barcode to electronically sign a report.

Note: Supervisors must have an electronic signature on file to electronically sign or approve reports.

ExternalControlReport


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An External Control Report is createdwhen a predefined external control is processed on ePlex and the reportcontains results, run and cartridge specific information. The External Control Report is similar to a Detection Reportwith additional information below:

l ExpectedResult

l Pass/Fail

Each external control has a user predefined expected result per target set on the Tools > External Controlsscreen.The External Control Report compares the result with the expected result and if they match the target passes and ifthey do notmatch the target fails. If all targets and the internal control pass the external control run passes.

ViewReport1. Go to Reports > Sample Results.

2. Select the external control sample(s) as indicated by Control under Sample Type .

The selected report(s) can be viewed in PDF format. Multiple reports can be selected and opened at once using thecheck boxes next to the accession ID.

PrintThis will print the visible report to the configured printer.


Export AsThis will allow the user to select the export path and file type of the export.


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Export DataRaw data may be requested by GenMark Technical Support and can be exported to the selected raw data exportpath (all selected results).

Send to LISUsers may transmit the external control result to an LIS by selecting Send to LIS.

Note: Send to LISmay be disabled if LIS communications is disabled in Settings > LIS or the External ControlReport has not been approved (assuming Approval required for manual release is checked).

SignOnly the Operator that started the run may electronically sign as the operator for External Control Reports.

The run Operator must either enter their username and password or scan their user barcode to electronically sign areport.

Note: Operators must have an electronic signature on file to electronically sign reports.

ApproveSupervisor users may electronically sign as the approver of External Control Reports. The Supervisor must eitherenter their username and password or scan their user barcode to electronically sign a report.

Note: Supervisors must have an electronic signature on file to electronically sign or approve reports.


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Summary Report

An assay-specific Summary Report for a user defined filter criteria is available on the Results > Results Summarytab. This report includes basic data analytics for the summary data set including:

l Total Tests

l Tests with Target(s) Detected

l Tests with No Target(s) Detected

l Invalid Tests

l Percent of Tests with Target(s) Detected

SearchFiltersSummary Report allows users to customize a report per assay using the following criteria:

l Assay Name

Note: Assay name selection is required prior to selecting other filter criteria.

l Date


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l Software Version

l Operator

l Bay Location

l Bay Serial

l Cartridge Lot

l Sample Typel Sample

l Control

l LIS Statusl Released

l Not Released

l Overall Resultl Detected

l Not Detected

l Invalid

l SignedStatusl Signed

l Not Signed

l ApprovedStatusl Approved

l Not Approved

As filter criteria is populated by the user, the total results associatedwith the search criteria are calculated in real-time and displayed at the bottom of the screen.

ViewSummary Report1. Go to Reports > Results Summary.

2. Choose an Assay Name.

3. Select any additional filter criteria.

4. Select View Summary Report.

Export DetailsExport Details will export all the data associatedwith the filter criteria in .csv format to the configured export reportsoutput path in Settings > Reports. The default sample sort order is bay run completed date/time with newest at thebottom. For additional assistance using this export please contact GenMark Technical Support.


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User AccessReport

A report containing information about each User including:

l Site Identifier

l Instrument Serial Number

l Software Version

l Username

l Full name

l Role - Operator or Supervisor

l Status - Active or Inactive

l Last Login - Date and time user last logged in

ViewUserAccessReport1. Go to Reports > User Access.


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Print UserAccessReport1. Go to Reports > User Access.

2. Select Print.

ExportThis will export the selected report to the configured export output directory as the configured export type of file.

Export AsThis will allow the user to select the export path file type of the export.

SystemManifest Report

The systemmanifest report includes the following elements for each:

Installed Assay

1. Name

2. Version

3. Part Number


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4. ReleasedDate

5. Install Date

6. Installed By

7. Active/Inactive status

Installed Tower

1. Position

2. Serial Number

Installed Bay

1. Location

2. Serial Number

3. Install Date - Date this Bay Serial Number was installed into this Bay Location

4. FWPart Number

5. FWVersion

6. FW Install Date

7. Last UsedDate/Time - Date/Time when this bay was last used to start a sample test

8. Enabled / Disabled

Installed External Software Component

1. Name

2. Version

3. Part Number

4. Release Date

5. Install Date/Time

ViewSystemManifest Report1. Go to Reports > SystemManifest.

Print SystemManifest Report1. Go to Reports > SystemManifest.

2. Select Print.


Export AsThis will allow the user to select the export file type and location of the export.


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Chapter 6. SettingsThe Settings tabs are where the system configuration settings for ePlex are located. The following tabs areavailable:

General - Date/time, workflow, UPS, login, password and volume settings

Reports - Report header information, printer and export configuration

LIS - Enable LIS and automatic release settings

Assays - Assay import and configuration

Bay Configuration - STAT configuration, bay status, reset bay and performOQ

Data - Database management

Users - User management and alert notifications configuration

Network - Email server and network drive configuration

GeneralSettings

Configure date/time formatThe language for the ePlex system cannot be changed by Operator or Supervisor users. Please contact GenMarkTechnical Service.

The date and time format that is used on the user interface and all reports can be configured using the drop-downlists.

1. Go to Settings > General.

2. Select the drop-down list for the desiredDate Format:l M/d/yyyy (6/5/2015)

l M/d/yy (6/5/15)

l MM/dd/yy (06/05/15)

l MM/dd/yyyy (06/05/2015) default

l yy/MM/dd (15/06/05)

l yyy-MM-dd (2015-06-05)

l dd-MMM-yy (05-Jun-15)

3. Select the drop-down list for the desired Time Format:l h:mm tt (4:56 PM) default

l hh:mm tt (04:56 PM)


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l H:mm (16:56)

l HH:mm (16:56 and 08:56)

4. Select Apply.

Note: System date & time cannot be changed in the ePlex software. Please contact GenMark TechnicalSupport to change system date or time.

Configure default output path for troubleshooting package

The troubleshooting output path can be chosen via file browser. This is the desired path where troubleshootingpackages will be sent. If there is no default path chosen, the software will prompt the user for a path upon thecreation of each new troubleshooting package.

Note: This path must not be the C: drive. This path must exist and be accessible by the Windows user accountat the time of configuration.


2. Select Browse... under Troubleshooting Output Path.

3. Select an output path that is not the C: drive.

4. Select Apply.

AllowManual Entry ofAccession IDOnly a Supervisor user can configure ePlex to allow for both manual entry and pending test order (PTO) manual runworkflow.

Note: Positive sample identification (pos-ID) is not valid using the manual entry or the PTOmanual runworkflow and a manual entry flag stating "Manual start of a sample test" will be noted on the Detection Report.

Note: If this option is unchecked, the systemwill only allow the barcode scanner workflow to start a run.


2. To allow manual entry and PTOmanual run workflow on the ePlex system, check the Allow manual entry ofaccession ID check box.

3. Select Apply.


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Configure UPSePlex software can be configured to interface with a UPS andwill automatically utilize a UPS for the instrument’sbackup power, if a UPS has been configured and connected to the instrument.

When the UPS is on battery mode, the ePlex software will prevent additional starting of tests andwill turn off theePlex display after 5minutes to conserve battery. Touch the display to turn the monitor back on. Any tests startedprior to the UPS entering battery mode will continue processing uninterrupted until the UPS battery drains to athreshold level at which point the software will attempt a safe shutdown, even aborting currently running tests. Theoptional 1500VAUPS can provide the following estimated run times shown below depending on howmany bays areprocessing samples.

1Tower 2Tower 3Tower 4Tower

EstimatedRunTime (min) 39-86min 21-69min 13-52min 10-40min


2. If a UPS is connected to ePlex, check the UPSConnected check box. Uncheck box if a UPS is not connectedto ePlex.

3. Select Apply.

Software

Install Software


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2. Select Install Software....

3. A pop up file browser will appear.

4. Select the software version (upgrade or downgrade) from a USB drive or Network Drive.

5. Select Select.

Note: No data will be lost during a software upgrade.

Warning: In the case of a software downgrade, data generatedwith the newer software may be lost afterdowngrading. Backup database prior to downgrade of software.

Restart Software

The ePlex software can be restarted if needed to resolve software issues. Though not advised, software can berestartedwhile tests are running in cases where this is required. Upon software restart, communication will be re-establishedwith bays andBay icons will display the current bay status.

Note: Runs will complete and results will be available if the run completes while the software is restarting.

Note: Restarting software will not impact current test processing.

1. Press the Restart icon on the toolbar.

OR


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2. Go to Settings > General and select Restart Software .

3. A verification pop upwill appear .

4. Select Yes or No.

UserManagement Settings

Set Auto Logout

Auto logout is the length of time (minutes) of user inactivity after which the systemwill automatically logout the user(0-60minutes, where 0means never). The systemwill revert to the login screen and there will be a message underthe password text box stating "Logged out due to inactivity".


2. Select the Auto Logout text box.

3. Enter the desired time for a user to be auto logged out for inactivity (0-60min; 0 = no auto logout).

4. Select Apply.

Set Password Expiration

The number of days prior to password expiration can be configured to be between 0 and 365 days, where 0indicates that the passwords never expire.

The password expiration warning interval has a default of 10 days, but can be a value of 0-30 days. This means thatif a user's passwordwill expire in 10 days, upon login the user will receive a warning stating that the passwordwillexpire in 10 days. If this is set to 0, users will never see a password expiration warning.


2. Select the Password Expiration text box.

3. Enter the desired number of days for a user password to expire (0-365 days; 0 = no expiration).

4. Select Password Expiration Warning text box (optional).

5. Enter the desired number of days before password expiration will the system issue a warning to the user uponlogin (0-30 days; 0 = no warning).

6. Select Apply.


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Set Audio VolumeTo adjust the audio volume of the internal ePlex speaker, move the sliding bar between 0 (quietest) and 100(loudest).


2. Select the preferred audio volume using the slider bar.

Note: The systemwill play a tone at the set volume level to assist with volume adjustment.

3. Select Apply.

Report Settings


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Configure Site Information

Site Identifier

The site identifier can be 0-20 alphanumeric characters with dashes/spaces allowed. This is set by GenMarkTechnical Support is the GenMark account number for the site.

Note: Please do not change the Site Identifier unless authorized by GenMark personnel or authorized servicepersonnel.

1. Go to Settings > Reports.

2. Select the Site Identifier text box.

3. Enter the site identifier and Enter.

4. Select Apply.

Instrument Serial #

The instrument serial number is configured by GenMark Support personnel upon installation and cannot be editedby Operator or Supervisor users. The serial number is used to identify the ePlex systemwhen calling GenMarkTechnical Support.

Report Logo

Users may customize the report logo with an image file which will be included on every report. Support file formatsinclude png, bmp and gif.

Note: png format is the preferred file format for use on ePlex.

1. Go to the Settings > Reports.

2. Select the Report Logo’s Browse… button.

3. Select a file type (jpg, bmp, png, gif) from the file type drop-down list.

4. Locate the image file.

5. Select Select.

6. Select Apply.

LabName

The lab name is printed on every report. It may be 0-20 characters (alphanumeric with dashes, spaces, commas,and periods allowed).


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2. Select the LabName text box.

3. Enter the lab name and Enter.

4. Select Apply.

LabAddress

The lab address is printed on each report. It may be 2 lines with maximum of 40 characters each (alphanumeric withdashes, spaces, commas, and periods allowed).


2. Select the LabAddress text box.

3. Enter the lab address and Enter.

4. Select Apply.

PrinterSettings

Default Printer

The default printer (either local or network) can be selected via a drop-down list.


2. Choose the Default Printer from the drop-down list.

3. Select Apply.

Report Template

Reports may be printed on 8½" x 11” (Letter) or 210mm x 297mm (A4) paper.


2. Choose the Report Template from the drop-down list (Letter or A4).

3. Select Apply.


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Add a Local Printer


2. Select AddPrinter .

3. Select the Local Printer check box.

4. Select Browse next to the Printer Install Package Path field.

5. Locate printer package through the file browser.

6. Select Select.

7. Enter a display name for the local printer.

8. Select Add.

Add aNetwork Printer


2. Select AddPrinter.

3. Select the Network Printer.

4. Select Browse next to the Printer Install Package Path field.

5. Locate Printer Package through the file browser.

6. Select Select.

7. Enter a display name for the network printer.

8. Type in the network printer address of the network printer in the Printer Network Address text field.

9. Select Add.

Delete a Printer


2. Select Delete Printer.

3. Select the Select printer to delete drop-down list on the Delete Printer pop up screen.

4. Select the printer.

5. Select Delete.

Auto Print Reports

ePlex can automatically print Detection and External Control Reports upon completion of runs to the default printer.If this is enabled, Detection and External Control Reports are automatically printed to the default printer for a given


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sample at run completion.


2. Select Auto Print Reports to enable automatically printing Detection and External Control Reports.

3. Select Apply.

Auto Print Screen Captures

If this is enabled, all screen captures will be automatically printed to the configured printer after the Screen Capture

icon is selected.


2. Select Auto Print Screen Captures check box to enable automatically printing screen captures to the defaultprinter.

3. Select Apply.

Export Reports

Default Export File Type

Reports can be exported to a USB drive or a Network Drive in the following formats: csv, xml, txt, or pdf.


2. Select the desiredDefault Export File Type for all report exports (csv, xml, txt, or pdf).

3. Export path and file type can be modified using Export As when viewing a report.

Default Output Path


2. Select the desired output path by selecting Browse.Note: Output path can be a USB drive or a mapped network drive. ePlex cannot export reports to thelocal C: drive.

3. Select Apply.

SetData Export


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Output Path

The user may export bay raw data for those samples that have bay raw data remaining (not purged) in the database.


2. Select the desired output path by selecting Browse.Note: Output path can be a USB drive or a mapped network drive. ePlex cannot export reports to thelocal C: drive.

3. Select Apply.

LIS Settings

ePlex is designed to communicate with global Laboratory Information System (LIS) vendors using either standardASTM andHL-7 communication protocols. ePlex can communicate in a bi-directional mode by receiving test ordersfrom the site LIS and storing them in Pending Test Orders. ePlex has configurable options for sending test results tothe LIS upon run completion. Only Supervisor users can modify settings on this tab.


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Enable LIS communicationSupervisor users have the ability to configure LIS communications as enabled or disabled .

1. Go to Settings > LIS.

2. Select the Enabled check box to enable or disable LIS communication.

Note: LIS communication must be enabled prior to receiving test orders or sending test results to theLIS.

3. Select Apply.

Approval Required forManual ReleaseIf LIS communication is enabled, Supervisor users can configure whether approval signature is required prior to


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manually sending the results to the LIS for a given sample result using the Signature required for release check box.

1. Go to the Settings > LIS.

2. Select the Approval required for manual release check box requiring aSupervisor user to approve prior to sending test results to the LIS.

Note: If Approval required for manual release is checked, the Send to LIS button isdisabled until Supervisor electronically signs the report.

Note: Approval required for manual release does not apply to Automatically Release LIS results andonly applies toManually Release results.

Note: User must have an electronic signature on file to electronically sign or approve reports.

3. Select Apply.

Automatic orManual Release Test Results to LISSupervisor users have the ability to configure ePlex to automatically send test results to the LIS upon runcompletion. Any combination of following results can be selected to automatically send to LIS.

Note: If any of the options are checked below results will automatically be sent to LIS upon run completionregardless of the Signature required for release setting.

l Invalid - All invalid test results

l Not Detected - All overall "Not Detected" results. All targets on panel are "Not Detected."

l Detected - All overall "Detected" results. One of more targets on panel are "Detected."

l Max Targets - Select the maximum number of detected targets allowed for automatic releaseNote: If max targets value is 2, only reports with 2 or less detected targets will be automatically releasedto the LIS. Reports with 3 or more detected targets will be held for manual release.

l Controls - All predefined external controls

1. Go to Settings > LIS

2. Select the check boxes for the desired test results ePlex will automatically or manually send to the LIS upon

run completion.

3. Select Apply.


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Assay Settings

All / ActiveThese check boxes can be used to view all assays in the system, or just the assays that are currently active.

AssaysConfiguredThe following elements are displayed for each assay:

l Assay Name

l Version

l Description

l Active status

l Release Date

l LIS Test Identifier - used for communications with the LIS to request test orders and send test results for theassociated assay


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Adding aDisclaimer

Each ePlex assay has an optional customer disclaimer (up to 200 characters) which will be added to the DetectionReport footer for all associated samples running the assay.

1. Go to Settings > Assays.

2. Select the Disclaimer icon under Disclaimer.

3. Enter disclaimer and select Enter (up to 200 characters).

4. Select Apply.

Select Select.

Importing AssayDefinitionsNew assays may be imported by Supervisor users or GenMark authorized personnel.


2. Select Import assay.

3. Select a valid Assay Definition File (ADF) from the file browser.


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4. If the assay definition is successfully imported, there will be a confirmation dialog .

5. Select OK.

Managing AssayDefinitions1. Go to Settings > Assays.

2. Select All to display all active and inactive assay definitions.

3. Use check box to activate or inactivate an assay.

4. Select OK to dismiss the confirmation dialog.

Note: When a new assay definition is imported, the software will mark the previous active version as inactiveupon successful upgrade (or downgrade) of a new assay definition of the same assay name.

Configuring Assay TargetsDepending on the assay, ePlex allows for defined customization of assay targets. Users may have rights to enableand disable individual targets or groups of targets.


2. To disable a target, uncheck the box next to the associated target or group .

3. To enable a target, check the box next to the associated target or group .

4. Select Apply .

Note: Certain targets cannot be disabled depending on the assay or user rights.


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BayConfigurationSettings

STAT BaySettingsePlex's optional STAT functionality is intended to reserve a configured number of bays to ensure bay capacity forhigh priority STAT tests. The STAT indication is only applicable when the STAT bay limit has been reached orexceeded. A STAT password is required to start a run on a STAT bay. There is a 1-minute inactivity timer for STATpassword entry and the software will cancel the test if the STAT inactivity timer expires.

Note: If this functionality is needed,1 or 2 reserved bays are generally adequate depending on the laboratoryworkflow.

1. Go to the Settings > Bay Configuration.

2. Enter desired number of ReservedBays (must be less than or equal to the number of configured bays).


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Note: When the configured number of reserved bays equals or exceeds the ready bays, ePlex willrequire the STAT password to start a test.

3. Enter STAT Password.

Note: Passwordmust be 6-10 alphanumeric characters.

Note: Ensure all users required to start STAT run know this password.

4. Select Apply

Upon inserting a cartridge into a STAT bay, the followingmessage to enter the STAT bay passwordwill appear. Usermust enter the STAT password to start the run.

Configured Towers andBaysThe serial number and location are displayed for each installed tower.

Each of these elements will be displayed for each configured bay:

1. Bay Location

2. Bay Serial Number, last known if not connected

3. Status: Current State

4. Part Number

5. Version: Bay Firmware Version, last known if not connected

6. Last UsedDate/Time

7. Install Date/Time


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Enable / Disable Bays

Disable aBay

In the event of a bay hardware failure, a bay may need to be disabled in order to be serviced.

1. Go to Settings > Bay Configuration.

2. Select the check box next to the desired bay to disable .

3. Select Disable.

Note: When a bay is disabled the Bay icon on the Run view will be grayed out, bay LEDwill turn off andwill be unusable.

Enabling aDisabled Bay


2. Select the check box next to the desired bay to enable.

3. Select Enable.

Note: When a bay is changed from disabled to enabled it will complete a power-on self test (POST) prior toentering the ready state.

Install Firmware


2. Select the check box next to the desired bay(s) for firmware installation .

3. Select Install Firmware.

4. Follow on-screen instructions.


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Reset Bay

Baysmay need to be reset if the Bay icon is blinking red to bring the bay back to a Ready state.


2. Select the check box next to the desired bay(s) to be reset .

3. Select Reset.

Data Settings


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DatabaseBackup

PerformDatabaseBackup

Users may perform a database backup and can specify the path of the database backup file. There is an option tocancel an in-progress database backup if needed.

1. Go to Settings > Data.

2. Select PerformDatabase Backup.

3. Use the browser to specify the path to save the database backup (.bak) fileNote: Path cannot be on the local C: drive.

4. Select Select.

RestoreDatabaseBackup

A database backup file may be restored. The current contents of the database will be overwritten. The user will beprompted for confirmation before a database backup is performed.

Warning: Restoring a database may result in lost data on the currently installed database. Ensure youbackup the current database before restoring the database.


2. Select Restore Database Backup.

3. Use the file browser to select the database backup file (.bak).

4. Select OK.

Purging DataA database purge can be performed. The user will be prompted to specify the date of the oldest result records toretain in the current database.

Warning: Purging a database may result in lost data older than the cutoff date. Once the database is purgedall sample data older than the cutoff date will be deleted. Ensure you backup the current database beforepurging the database.


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2. Use the Calendar icon to select the Cutoff Date for the data purge.Note: All data older than the cutoff date will be purged.

3. Select Purge Database.

4. Select OK to confirm you dowant to purge the database.

5. Select OK to confirm the database was successfully purged.

Automatic DatabaseBackupePlex can be configured to perform automatic database backups.

To schedule an automatic database backup:


2. Select the desired Backup Folder path using Browse....

3. Use the file browser to select a path where the automatic database files will be stored.

4. Select Select.

5. Select one of the following from the Backup Frequency drop-down list:

l Daily

l Weekly

l Monthly

l Never

Note: If monthly is selected, the software performs automatic monthly backups on the 1st of the month.

6. Select the Backup Time.

Note: It is recommended to choose a time of day when instrument is not processing samples.

7. Select one of the following from the Day of week drop-down list:l Sunday

l Monday


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l Tuesday

l Wednesday

l Thursday

l Friday

l Saturday

8. Select Apply.

User Settings

All / Active ConfiguredUsersSelect All or Active to view either all User accounts or just active users. Users cannot be deleted they can only beinactivated by a Supervisor. The following User information is displayed for all User accounts:

l Username (username used for logging in)

l Full Name (full name assigned to this user)

l Role (operator or supervisor user)

l Status (active or inactive)


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Creating Users1. Go to Settings > Users2. Select Create3. Enter the following fields (some are optional):

l First Namel Required

l 1-20 character length, alpha only

l Last Namel Required

l 1-20 character length, alpha only

l Usernamel Required

l 6-20 character length, alphanumeric

l Every User must have a unique Username

l Passwordl Required

l Passwords are 6-20 character length, case-sensitive, alphanumeric and/or specialcharacters:`~!@#$%^&*()_-+={[}]:;”<,’>.?/.

l User AssignedRolel Required

l Active status [Active or Inactive]l Required

l Electronic Signaturel Optional, though required to electronically sign or approve reports

l Primary Email Addressl Optional

l Secondary Email Addressl Optional

l Notification Settingsl Optional

4. Select Apply.

Note: Passwords must be reset or changed using the Current User icon

Creating anElectronic SignatureUsers must create an electronic signature in order to electronically sign and approve reports.

1. User must be logged in under their own account.

2. Go to Settings > Users.

3. Select their username from the list of users to view the edit user screen.

4. Use the touchscreen to create a signature in the white box on the right hand side of the screen.


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Note: Use a single finger andmove the finger slowly to achieve the best results. Signature must bewritten within the white box.

5. Select Apply.

Edit UserAccountAll users may edit the following account attributes:

l Password

l Primary Email Address

l Secondary Email Address

l Alert notification settings

l E-signature Image

In addition Supervisor users may edit the following for all accounts:

l Role

l Reset (authentication) Password

l Active status [Active or Inactive]

Note: Operator users may only edit settings for their own account. Supervisor users can edit settings for otherusers.

Note: Supervisor users can reset the password of all other users in the ePlex (including other Supervisorusers).

Note: If all Supervisor users forget their passwords, GenMark Technical Support can provide a uniqueusername and password. This login information will be valid exclusively on the applicable serial number ePlexfor one day. Supervisor users should use the provided username and password to issue new Supervisorpasswords on the Settings > Users tab.

ChangePassword

1. Select the Logout icon to go to the login screen.


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2. Select Change Password.

3. Fill in the Username, Current Password, New Password, andConfirm Password fields.Note: Passwords are 6-20 character length, case-sensitive, alphanumeric and/or specialcharacters:`~!@#$%^&*()_-+={[}]:;”<,’>.?/.

4. Select Login.

Alert NotificationsAlert notifications for warnings and results can be configured to be sent to users via email using either HTML or Textformat. Notifications can be sent immediately or scheduled for a specific hour. Each user can manage their ownnotifications, while Supervisor users can manage notifications for all users.

Note: The Username "SYSTEM" is for notifications when no user is associated to the event. For examplewhen no user is logged into the system.


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Alert Email Notifications for Warnings contain:

l Alert Message

l Date/Time – alert was generated

l Operator at time of alert

l Instrument serial number

Alert Notifications for Results contain:

l Accession ID

l Date / Time – run completed

l User that started the run for the sample

l Instrument serial number

Note: Sample target results are not included in the email notification.

Configure Alert Notifications


2. Select the user account to edit.

3. The system allows the user to edit the following:l Primary Email Address

l Secondary Email Address

l Notification Settings

4. Make edits and then select Apply.

UserBarcodeePlex generates a unique 2D datamatrix barcode


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for each user to quickly log into ePlex, sign and approve (Supervisor only) reports. The user barcodecan be sent to email, file, or printer. A new user barcode is requiredwhen User password changes.

Note: The User barcode is encrypted to protect the User's username and passwordwithin the barcode.

SendUser Barcode


2. Select SendBarcode.

3. Choose one of the following:l Default Printer - will print the user barcode

l Email Address - will send image file of user barcode to the configuredUser email

l Save to file - save image file of user barcode to a browsed path

NetworkSettings


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Configure Email ServerConfigure site email server settings if email alert notifications and email user barcode functionality is desired.

1. Go to Settings > Network.

2. Enter the following fields:l SMTPServer - SMTP address for site email server

l SMTPPort - SMTP port for site email server

l Username - Username for sender email account for ePlex alert notifications

l Password - Password for sender email account for ePlex alert notifications

3. Select Apply.

4. Select Test Email to send a test email to confirm server and settings are functional.

Mapping aNetwork Drive

1. Go to Settings > Network.

2. Under Network Drives, select Add.

3. Enter the following fields in the Connect to a Network Folder pop-up:

l Server name (ex. eplexdatasvr)

l Note: this is the host /computer name. There are no slashes in the name.


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l Server path (ex. microbiology\ePlexBackups)

l Note: Do not enter the server name here only the path to the folder

l Username (ex. genmark\johnsmith)

l Note: Domain and username need to be provided. Domain\Username

l Password

l Note: Password of username specified above

4. Select Save

Note: ePlex can map up to 10 network drives.

Note: ePlex can only use one network user login per server location tomap a drive.

Delete aNetwork Drive1. Go to Settings > Network.

2. Select the network drive to be deleted.

3. Select Delete.


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Chapter 7. ToolsThe Tools tabs contain additional functionality for predefining external controls, viewing system events andtroubleshooting. The following tabs are available:

External Control - Pre-define assay external controls

System Events - View system events

Troubleshooting - Create troubleshooting packages

ExternalControls

ePlex allows customers to predefine external controls per assay to automatically track frequency and enablePass/Fail result report analysis. Predefining external controls is optional. External control samples can be run similarto a patient sample without being predefined, however functionality to assist with results analysis will not be usable.

When predefining external controls consider the following:

l Consult GenMark authorized personnel to assist with your external control strategy.

l Each assay requires its own external controls.

l Each assay targetmust be linked to a predefined control to satisfy a "Detected" and "Not Detected" result.


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l All targets must have a valid "Detected" and "Not Detected" result from a predefined control to be countedtowards QC frequency (lot or time).

l ePlex will notmonitor QC requirements for frequency of reagent shipments.

l ePlex tracks ePlex cartridge lot printed on the individual foil pouch and printed as C.LOT on the cartridge box.Cartridge lot is also programmed on the EEPROM.

Control IdentificationReportA report containing data for each predefined external control including:

l Last date and time it was run

l Barcode image

l Target identifications

l Remaining days until due

1. Go to Tools > External Control.

2. Select View Report.

Predefine External Controls1. Go to Tools > External Control.

2. Select Add.

3. Select the Accession ID text box and enter the accession ID (name of the external control).Note: The Accession ID cannot contain spaces.

Note: External Control accession ID's must be unique and different than all expected patient accessionIDs.

4. Select the assay from the assay drop-down list.

5. Enter comments (optional).


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6. Use check boxes to select desired results as Detected or Not Detected under Target/Result.

Note: Each assay requires predefining each target with at least one Detected and one Not Detectedexternal control.

Note: At least 2 external controls are required per assay to cover both Detected andNot Detectedconfigurations per target.

7. Select Add.

Delete anExternal Control1. Go to Tools > External Control.

2. Select the external control you wish to delete.

3. Select Delete.

Send External Control BarcodeThe external control barcode is automatically generated based on the configured Accession ID andmay be sent todefault printer, email address, or save to file.


2. Select the desired external control .

3. Select SendBarcode.

4. Choose one of the following:l Default Printer - will print the user barcode

l Email Address - will send image file of user barcode to the configured user email

l Save to file - save image file of user barcode to a browsed path

6. Select Send.

Configure External Control AlertePlex monitors external control usage and can alert users when external controls are due based on run frequency (days) and cartridge lot change. Supervisor users can configure ePlex to restrict starting new tests if QC is past due.


2. Select the Run Frequency (Days) check box (optional).

3. Enter number of days .Note: The run frequency may be enabled or disabled and has a range of 1-100 days (default: 30 days).

4. Select Lot Change check box (optional).

5. Select the Require valid control(s) prior to perform tests check box (optional).

6. Select Apply.


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SystemEvents

The System Events tab displays all system events (both alerts and audits).

SystemEvents FilterCriteria:l Username

l Date Range

l Type of Log (Alert or Audit)

l Severity of the Alert, if applicablel Informational - An alert that does not require operator intervention

l Warning - An alert that requires operator intervention

ViewReportThe selected report(s) can be previewed in PDF form by selecting View Report

ExportThis will export the selected report to the configured export output directory as the configured export type of file.


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Export AsThis will allow the user to select the export file path and type of the export.

Troubleshooting

Upon request fromGenMark authorized personnel users can create troubleshooting packages into a singlecompressed zip file. The compiled zip file is encrypted and is intended for and can only be opened by GenMarkauthorized personnel.

Creating Troubleshooting Packages

1. Go to Tools > Troubleshooting.

2. Select the requested date range.

3. Select the type of troubleshooting package from the drop-down list:l Default

l Select All

l Custom (Select all that apply)l Application Logs

l Database Backup


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l Process Control Logs

l Screen Capture Files

l Sample Reports

l System Event Log Report

l SystemManifest Report

l SystemUsage Report

l Data Exports

l Raw Data Exports

4. Select Export.

5. If the troubleshooting package export path has not been defined, the system displays a pop upwindowallowing the user to choose where to export the troubleshooting package.

6. Select the destination path using browse.

7. Wait for the message "troubleshooting package was successfully created" and select OK.

Note: Creating and compiling a troubleshooting package may take greater than 10-15minutes depending ondate range and content selected.

Maintenance

When the ePlex is used in the standard laboratory environment under optimal working conditions, ePlex requires aperiodic preventative maintenance by GenMark personnel or authorized service personnel. ePlex should undergoperiodic cleaning, which can be administered by a GenMark-trained lab technician.

Cleaning the Instrument Surfaces

ePlex’s outer surfaces should be cleanedmonthly or more frequently to prevent any substances from potentiallyinterfering with the functionality of the instrument.

Warning: Perform only the procedures andmaintenance described in this operator manual. Before usingany cleaning or decontamination method not outlined in this documentation, contact GenMark TechnicalSupport to ensure the methodwill not damage ePlex.

CleaningMaterials

l 10% sodium hypochlorite solution

l Ethanol or isopropanol

l Lint-free wipes

l Disposable gloves

l Eye protection

Warning: Wearing disposable gloves and eye protection reduces the risk of exposure to biologicallyhazardous samples.

Instrument SurfaceCleaning ProcedureObserve the following safety precautions when cleaning ePlex:


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Warning: Never spray the instrument directly with any fluids.

Warning: Do not use aromatic based solutions, moisturizing or antibacterial soap, scented oils, or solvents,such as acetone or isopropanol, to clean the Instrument. As necessary, clean the touchscreen with a glass-cleaning solution on a soft cloth.

Warning: Be careful when cleaning the Instrument. Make sure no liquid is introduced into the cartridge slots.Additionally, do not insert any type of material or object into the slots other than the cartridges.

1. Dampen a lint-free wipe with 10% sodium hypochlorite solution.

2. Wipe all exterior surfaces with the lint-free wipe.

3. Wait at least 5minutes.

4. Dampen a lint-free wipe with ethanol or isopropanol.

5. Wipe all exterior surfaces with the lint-free wipe.

Note: Discard all usedwipes according to your laboratory procedure.

CartridgeDecontaminationBiohazardWarning: If any cartridge leaks and contains potentially infectious material, the risk of biohazardcontamination exists. Please contact GenMark Technical Support immediately.


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Chapter 8. ReferenceThis section provides detailed reference information for each screen and field displayed on ePlex. It is to be used inconjunction with the operational guidelines throughout this manual.

ePlexSpecifications

Configuration 1 Tower 2 Tower 3 Tower 4 Tower

Bays 6 12 18 24

Throughput (8hrs) Up to48samples Up to96samples Up to144samples Up to192samples

PhysicalDimensions

(HxDxW)

59cmx48cmx54cm

23.5 in x19 inx21.3 in

59cmx48cmx72cm

23.5 in x19 inx28.5 in

59cmx48cmx91cm

23.5 in x19 inx35.8 in

59cmx48cmx109cm

23.5 in x19 inx43 in

Weight 49kg (108 lbs) 79kg (173 lbs) 108kg (238 lbs) 138kg (303 lbs)

PowerUsage 265W(Peak) 410W(Peak) 555W(Peak) 700W(Peak)

HeatDissipation 904BTU/hr 1399BTU/hr 1894BTU/hr 2388BTU/hr

LISCompatibility

ASTMLIS1-A&LIS2-A2 (Bi-directional)

HL7v2.3 (Bi-directional)

Flat File (.csv, .xml, and .txt)

I/OPanel

4xUSB3.0

2xUSB2.0

1xRJ-45Gigabit LAN

1xRS-232 (DB9male)

PowerRequirements 100-240Vac, 50/60Hz

EnvironmentalConditionsAmbient Temperature: 15- 30°C

RelativeHumidity: 15- 85% (Non-condensing)

WasteRequirements Follow your regional/countryhazardousandmedicalwaste disposal requirements.

Safetyand ElectromagneticCompatibility (EMC)Stand-

ards

EN61326-2-6:2013, EN61010-1:2004, EN61010-2-101:2002, CAN/CSA-C22.2NO. 61010-1-12, ENISO13485:2003, ENISO14971:2012, EN ISO15223-1:2012, CISPR11:2015

BarcodeRequirements

The accession ID barcode label mustmeet the following requirements for use on the ePlex System.


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Accession ID Barcode Label Requirements

MaximumLabelHeight 25.4mm(1.0 in)

MaximumLabelWidth 50.8mm(2.0 in)

NumberofCharacters 1-25

AllowedCharacters Alphanumeric and dash "-" (spacesand other specialcharactersare not allowed)

Quiet ZonePlease ensure adequate quite zonewhite space around thebarcode. Recommend 6.3mm(.25in)

Print Resolution Minimum300dpi, recommend 600dpi

QualityANSI X3.182GradeCorhigher

ISO/IEC15416Grade2orhigher

Supported BarcodeFormatsAztec, Codabar, Code39, Code93, Code128, DataMatrix, EAN, Interleaved 2of5, JAN,Maxicode, UPC


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Chapter 9. Troubleshooting

Common Issues andSolutions

The following offers some basic troubleshooting guidelines and tips for general usage of ePlex . If instructions in thetable below instruct you to contact Technical Support please refer to the location section of this manual for theTechnical Support contact information.

Hardware Troubleshooting

Resetting aBay

If a cartridge is removed from a bay and the bay remains in an error state, the user will need to reset the bay andclear the error.

To reset a bay:


3. Select the Bay(s) .

4. Select Reset.

When the reset is complete, the bay status will be “Ready” indicated by a static white light.

BayReplacement ProcedureBay replacement will be performed by GenMark personnel or authorized service personnel unless instructed. Aftera bay has been replaced, the new bay will enter an error state and a Bay Operational Qualification must becompleted.


PI1066Rev. F

Note: Contact Technical Support if bay requires Operational Qualification unless otherwise instructed.

To Complete the BayOperationalQualification1. Go to Settings > Bay Configuration.

2. Select the bay with status of OQ Required.

3. Select PerformOQ.


PI1066Rev. F

4. Insert the test cartridge.

Note: Test cartridges are provided by GenMark for use during OQ.

5. When the process is complete, remove the test cartridge. The software will automatically display the BayOperational Qualification Report . The user can choose one of the following options:

l Print

l Export

l Export As

l Sign

Note: The report is no longer available after report preview is closed.

BayOperationalQualificationReport

The Bay Operational Qualification Report will include the following elements for each bay:

l Bay Location

l Previous Bay Serial Number, if applicable


PI1066Rev. F

Note: The previous bay that has successfully passed the OQ process. This may be the same as thecurrently installed bay.

l Previous Install Date, if applicable

l Previous Firmware Version, if applicable

l New Bay Serial Number

l New Install Date

l New Firmware Version

l Test Cartridge Serial Number (as read by Firmware)

l OQ process status (Pass/Fail/Aborted)

l For each bay that fails, details indicating the reason for failure

Error Codes

ePlex generates error codes for issues associatedwith bay firmware, instrument software and assay software.

Error Category Error Code Range

BayFirmware 1000- 3999

InstrumentSoftware 4000- 9999

AssaySoftware 10000- 19999

Bay Firmware Error Codes andResolution

Error Code Error Message Resolution

1001 Bayvoltage failure

ResetBay

Export TroubleshootingLogs

Contact TechnicalSupport





1007 Invalid BayCommand Contact TechnicalSupport

1008 Bay toPC communication timeout Contact TechnicalSupport

1009 Baysub-systemcommunication timeout

ResetBay



1012 Baycomponent version invalid Contact TechnicalSupport




PI1066Rev. F


1016 Bayout ofassaymemory Contact TechnicalSupport

1018 Bayout of loggingmemory Contact TechnicalSupport

1019 Bayout ofscanmemory Contact TechnicalSupport

1022 Bay flashmemory failure Contact TechnicalSupport

1024 Baysub-systemmemory failure Contact TechnicalSupport

1026 Baysub-systemmemory failure Contact TechnicalSupport

1027 Baydetection failure Contact TechnicalSupport

1030Baymainmotor invalidmovementrequest

ResetBay



1032 Bay firmware failure

ResetBay



1033 Bay invalid parameter

1034 Baydetectionprocessingunresponsive

1035 Bay illegaloperation

1036 Bay fluidmovement failure

1037 Baydetectionprocessingbusy


1039 Baycommunication failure

1040 Bay fluidmovement failure


1042 Bay internal timeout

1043 Baymain/fluidmotor failure Contact TechnicalSupport

1044 Baymain/fluidmotor failure Contact TechnicalSupport

1045 EEPROMfailureCheck consumable EEPROM

Contact TechnicalSupport1046 EEPROMfailure

1047 EEPROMfailure

1049 Diagnostic cartridge unresponsive Contact TechnicalSupport

1050 Diagnostic cartridge failure Contact TechnicalSupport

1051 Diagnostic cartridge failure Contact TechnicalSupport

1052 Cartridge not connected Contact TechnicalSupport

1053 Cartridge not present

ResetBay




PI1066Rev. F


1054 TopBaymotor failure Contact TechnicalSupport

1055 Bayoverpressured Contact TechnicalSupport

1056 Bay fluidmotorout ofposition foreject Contact TechnicalSupport

1058 Bayauto-calibration failure Contact TechnicalSupport

1059 Bayheater failure Contact TechnicalSupport

1060 Detection failure Contact TechnicalSupport


ResetBay



1062 BeadBeater failure Retest usingnewcartridge


1505 Bay fluidmovement failure Contact TechnicalSupport

1700 Bay temperature out of range Contact TechnicalSupport

1701 Baymagnet position failure

ResetBay


1710 Cartridge not present

1711 Cartridgepresent

1712 Cartridge not locked

1713 Cartridge Locked

1715 Cartridge failureInspect cartridge fordebrisonPCBContact TechnicalSupport

1716 Bay fluidmovement failure Contact TechnicalSupport

1717 Baypumppressure failure Contact TechnicalSupport

1900 Bayassaycommunication failure Contact TechnicalSupport


1902 Bay loggingmemory low Contact TechnicalSupport

1904 Bayscanmemory low Contact TechnicalSupport


Instrument Software Error Codes andResolution


4000 Anunexpected exception Contact TechnicalSupport

4001 Test aborted due to instrument issue Contact TechnicalSupport


PI1066Rev. F


4002 Test aborted byoperatoraction Contact TechnicalSupport

4003 TheapplicationshutdownviaUPSevent Contact TechnicalSupport

4004 Theoperatorauthentication failed Contact TechnicalSupport

4005 Theduplicate active bayaddresses Contact TechnicalSupport

4007 The test not started due touseraction Contact TechnicalSupport

4008 Thebayerror Contact TechnicalSupport

4009 Thebayentered error stateCheck consumable EEPROMContact TechnicalSupport

4010 Thebaypost failedResetBay


4011 Thebay failed toestablishcommunication Contact TechnicalSupport

4012 The firmwaremismatchUpdateBayFirmware


4013 The test initialization failure Contact TechnicalSupport

4014Theconfigured export path isnot access-ible

Checkwithsite IT foraccess tonetwork pathContact TechnicalSupport

4015Theconfigured rawdata export path isnot accessible

Checkwithsite IT foraccess tonetwork path


4016The troubleshootingpackage creation fail-ure


4017 The screencapture failed Contact TechnicalSupport

4018 STATBayPassword authentication failed Contact TechnicalSupport

4019Theexternalcontrol isdue tobe runaccording to the configured run fre-quency


4020 TheLIShost isdown Contact TechnicalSupport

4021 TheLIS transmission failed Contact TechnicalSupport

4022 Anunexpected barcodewasscanned Contact TechnicalSupport

4023Failed tosend acommand to thebar-code scanner


4024Failed to read acommand from thebar-code scanner


4025 Failed to initialize thebarcode scanner Contact TechnicalSupport

4026Externalcontrol isdue to runwithin thenext 2days


4027 Externalcontrol isoverdue tobe run Contact TechnicalSupport


PI1066Rev. F


4028 Failed toset the audiovolume Contact TechnicalSupport

4029 The fail to read anaudio file Contact TechnicalSupport

4030 Addinga tower failed Contact TechnicalSupport

4031 Enablingabay failed Contact TechnicalSupport

4032 Disablingabay failed Contact TechnicalSupport

4033 Sendinganemail failed Contact TechnicalSupport

4034 Barcodegeneration failed Contact TechnicalSupport

4035 Printing failed Contact TechnicalSupport

4036 Thebarcodeparsingengine failed Contact TechnicalSupport

4037 Thebarcodeparsingengine start failed Contact TechnicalSupport

4038 Thebarcodeparsingengine stop failed Contact TechnicalSupport

4039 Thecontrolupdate failed Contact TechnicalSupport

4040 UPSnot connected to thePC Contact TechnicalSupport

4041 LISautomatic release failed Contact TechnicalSupport

4024 StartingLIS failed Contact TechnicalSupport

4043 StoppingLIS failed Contact TechnicalSupport

4044 TheLIShost statusupdate failed Contact TechnicalSupport

4045 TheLISupdate assayconfiguration failed Contact TechnicalSupport

4046 Addinga flag toa test failed Contact TechnicalSupport

4047 Editing the accession identifier failed Contact TechnicalSupport

4048 Assigningcomment failed Contact TechnicalSupport

4049 Savingrawdata failed Contact TechnicalSupport

4050 Savingscandata failed Contact TechnicalSupport

4051 Saving the completed test failed Contact TechnicalSupport

4052 Savinga started test failed Contact TechnicalSupport

4053 The test order remove from test failed Contact TechnicalSupport

4054 The test ordersquery failed Contact TechnicalSupport

4055 UPSisconnected to thePC Contact TechnicalSupport

4056 UPSbattery started discharging Contact TechnicalSupport

4057Applicationshutdowndue toUPSbatterylife reachinga configured threshold


4058UPSswitched frombatterybackup backto line power


4059 Sent ifautomatic startup purgeworked Contact TechnicalSupport


PI1066Rev. F


asexpected

4060 Sent ifautomatic startup purge failed Contact TechnicalSupport

4061 Sent ifmanualpurgeworked asexpected Contact TechnicalSupport

4062 Sent ifmanualpurge fails Contact TechnicalSupport

4063 Databasebackup failed Contact TechnicalSupport

4064 TheLIShost isback up frombeingdown Contact TechnicalSupport

4065 An invalid filterdeleted Contact TechnicalSupport

4066Maxnumberofdayssinceour last purgewasmissed


4067 Help upgrade installer failed Contact TechnicalSupport

4068 Default printer statushasbeenupdated Contact TechnicalSupport

4069 Savingprocesscontrol logs failed Contact TechnicalSupport

4071 The firmware update failed Contact TechnicalSupport

4072BayQualificationTest upgrade installerfailed


4073 Bayqualification failed Contact TechnicalSupport

4074 Theautomatic print sample reports failed Contact TechnicalSupport

4075 Theautomatic export data failed Contact TechnicalSupport

4076 Theexternalsoftware added Contact TechnicalSupport

4077 Theexternalsoftware changed Contact TechnicalSupport

4078 Theexternalsoftware removed Contact TechnicalSupport

4079 Thedisk space is too low Contact TechnicalSupport

4080 Theexternalcontrol run isnot valid Contact TechnicalSupport

5001 Manualstart ofa sample test Contact TechnicalSupport

5002 Useofa previouslyused cartridge Contact TechnicalSupport

5003 Useofanexpired cartridge Contact TechnicalSupport

5004 Manually entercartridge information Contact TechnicalSupport

AssaySoftware Error Codes andResolution

ErrorCode

Error Message Resolution

10003 DataAnalysisError Contact TechnicalSupport




PI1066Rev. F

ErrorCode

Error Message Resolution


10011 ConfigurationDataError Contact TechnicalSupport

10012 ConfigurationDataError Contact TechnicalSupport

10013 RawDataProcessingError Contact TechnicalSupport



10019 ReportGenerationError Contact TechnicalSupport




10026 UnexpectedDataProfile Contact TechnicalSupport





10035 UDataAnalysisError Contact TechnicalSupport














PI1066Rev. F

Chapter 10. Glossary

A

Accession IDThe identifying nameor number given to a sample for tracking purposes, sometimes referred to as‘Sample ID’. LIS systems will generally assign an Accession ID for a patient.

ACVAlternating Current Voltammetry

ADFAssay definition file

AssayA series of programmed steps to performextraction, amplification, and detection procedures.

B

BayA processing unit in ePlex which will accept a cartridge containing reagents and instructions for adiagnostic test to be processed.

C

CartridgeThe ePlex cartridge consists of a specifically designed array of printed circuit board (PCB) surfaceelectrodes enclosed in a chamber which is packaged in a plastic consumable . The cartridge cham-ber is filledwith an immiscible fluid to isolate droplets and facilitate transport of the sample andreagent droplets.

E

EEPROMElectrically Erasable Programmable Read-OnlyMemory

ePlex systemComprises theBase, Tower(s), Bay(s), cartridges and accessories. Also referred to as ePlex.

F

FWFirmware on ePlex Bays


PI1066Rev. F

G

GUIGraphical User Interface

L

LISLaboratory Information System, a software application that handles receiving, processing, and stor-ing information generated bymedical laboratory processes. These systems often must interfacewith instruments and other information systems, such as hospital information systems (HIS). An LISis a highly configurable application that is customized to facilitate awide variety of laboratorywork-flowmodels.

O

OQOperational Qualification

P

PCBPrintedCircuit Board

PCRPolymeraseChain Reaction

POSTPower-On Self Test

ProtocolA set of instructions for controlling ePlex. Each assay has a unique protocol.

R

RT-PCRReverse Transcription PolymeraseChain Reaction

S

SMTPSimpleMail Transfer Protocol

STATMedical termmeaning immediately


PI1066Rev. F

T

TowerThe portion of ePlex containing a collection of six cartridge bays arranged vertically. The ePlex caninclude up to 4 towers

U

UPSUniversal Power Supply

USBdriveA data storage device that includes flash memorywith an integratedUniversal Serial Bus (USB) inter-face.


PI1066Rev. F

Chapter 11. Index

A

A4 69

Abort 32-33, 48

Accession ID 29, 33, 40, 43, 45, 52, 63, 88, 93, 100

Active 59, 61, 75, 84

Address 69, 85

ADF 76

Alert 94

Alert Notifications 47, 87

Alerts 26

Approval 54, 56, 73

Assay 20, 31, 43, 52, 57, 60, 75, 104

Assay Definitions 76

Assay Targets 77

Auto Logout 66

Auto Print 70

B

backup 64

Backup 14, 82

Bay 19, 24, 29, 44-45, 48, 52, 58, 61, 65, 78, 101, 104

Bay Configuration 36, 62, 78, 102

Bay Details View 31

Bay Errors 26, 46

Bay Location 31, 43, 52, 58, 61, 79, 103

C

Change Password 86

Cleaning 16, 97

Comments 31, 46

Controls 74

csv 58, 71, 99

Current User 26, 28, 85


PI1066Rev. F

D

Database 62, 82, 96, 109

Date 26, 43, 52, 57, 61-62, 79, 83, 88, 95, 104

Decontamination 98

Delete 43, 70, 91, 94

Detection Report 20, 24, 32, 38, 48, 50, 55, 63

Disable 80

Disclaimer 76

display 64

E

EEPROM 23, 93, 105

Electronic Signature 85

Email 62, 85, 90, 94

Enable 33, 62, 73, 80

ePlex 6, 8, 10, 12-13, 15, 17, 19, 23, 25, 27-28, 33-34, 36, 38-39, 41-42, 48, 50, 55, 62, 68, 72, 76, 78, 83, 86,92, 97, 99, 101, 104

Error 9, 31, 44, 46, 104

Esc 37

eSensor 6, 18, 22

Ethernet 19

Expiration 31

Export 33, 53, 55, 60-61, 71, 95, 103-104

Export Details 58

External Control 92

External Control Report 50, 54

External Control Reports 70

external controls 92

F

Filter 33, 95

Firmware 80, 104

G

GUI 20-21


PI1066Rev. F

H

Help 8, 26-27, 109

HTML 87

I

Import 33, 42-43

Install 34, 64, 70, 79, 104

Invalid 52, 57, 74, 104

J

jpg 68

K

keyboard 37

L

LabName 68

LED 24, 38, 80

LEDs 44

LIS 33, 42-43, 52, 56, 58, 62, 72, 75, 99, 107

Local Printer 70

Log 39, 95

Login 59, 87

Logo 68

Logout 26, 28, 86

Lot 52, 58

Lot Change 94

Lot Number 31

M

Maintenance 97

Manual Entry 26, 32, 38, 40, 46, 63

N

Network 62, 70, 89

Network Drive 65, 71, 90

Network Printer 70

Notification 85


PI1066Rev. F

O

on-screen 8

Operational Qualification 101

Operator 1, 32-33, 52, 56, 58, 68, 86

operator's 8

OQ 45, 102

Output Path 71

Outstanding Accession ID 30

P

Password 79, 85, 90

Password Expiration 66

Patient ID 31, 45

PCB 17, 22, 106

PCR 17, 22

Pending Test Order 42, 44

Pending Test Orders 26, 38, 42-43, 72

png 68

POST 33, 80

power-on self test (POST) 80

Print 53, 55, 60-61, 100, 103

Printer 69, 89, 94

purge 82

R

Raw Data 97, 110

Release 74-75

Remote 26

Reset 33, 81, 86, 104

Restart 26, 28, 33, 65

Restore Database 82

Results Summary Report 50

Rights 33

Role 59, 84


PI1066Rev. F

Run Frequency 94

Run View 29

S

Safety 8, 12, 99

Scan 24

Screen Capture 26-27, 97

Search 43, 51, 57

Serial Number 9, 31, 59, 61, 79, 103

Server 90

Settings 8, 25, 54, 56, 58, 62, 67, 73, 75, 78, 81, 84, 90, 101

Shutdown 15, 28

Sign 56, 103

Site Identifier 59, 68

SMTP 90

STAT 62, 78, 107

Supervisor 27-28, 33, 54, 56, 63, 72, 76, 84, 94

Symbols 12

System Events 92, 95

SystemManifest Report 50, 60, 97

T

Target 57, 93

Time 31, 61-62, 83, 88

Tools 8, 47, 55, 92-93, 96

Touchscreen 36

Tower 19, 61, 64, 99

Troubleshooting 8-9, 63, 92, 96, 101, 104

troubleshooting package 63

U

UPS 23, 64, 107

User Access Report 50, 59

User Account 86

User Barcode 88


PI1066Rev. F

Username 36, 59, 84, 90, 95

V

Volume 67

W

Warning 66, 95

Workflow 30


PI1066Rev. F

pi1066 eplex operator manual - genmark · chapter6.settings 62 generalsettings 62 installsoftware...

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