GenMark Dx ePlex User manual

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Quick ReferenceGuide

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Limited Warranty/Limited Liability
GenMark Diagnostics warrants to the original purchaser that products will be free from defects in
workmanship or materials for a periodof one (1) year from date of purchase under normal use. The sole
andexclusive remedy under this limitedwarranty is repair or replacement of defective products or parts
thereof. Repair or replacement products or parts thereof will be furnished solely on an exchange basis
andare obtainable only by the original purchaser.The original purchaser shall return the defective
product, or part thereof, properly packaged with postage or shipping costs prepaidtoGenMark
Diagnostics. Loss or damage duringshipmentshall be atthe riskof the purchaser.
This limitedwarranty does notinclude repair or replacement necessitated by accident, neglect, misuse,
relocation, unauthorized repair, or modification of the product. The above limited warranty is the sole
warranty provided by GenMark Diagnostics. Noother warranties, expressedor implied, including
warranties of merchantability or fitness for a particular purpose, are provided whatsoever. 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 the product. Someproducts may be deemed
non-returnable due their biological status. Accordingly, prior toreturninga defective or service-
requiring product, please contact GenMark’s technical services department to evaluate and arrange a
return.
Patents
The ePlex instrument and eSensor® electrochemical detection technology are proprietary to GenMark
Diagnostics, Inc. and, depending on specific application and configuration, embodied in one or more of
United States Patent Nos. 7,312,087, 7,172,897,6,602,400, 9,498,778,9,410,663, 10,391,489, 9,453,613 and
additional foreign and domestic patents and pending applications.
Licensing inquiries shouldbe directedtoGenMark's Legal Departmentat5964 La Place Court,
Carlsbad, CA 92008.
Unless otherwise agreed to in writing, by using the ePlex instrument, Recipient acknowledges that
Recipient has read, accepts and agrees to be bound by and comply with the Terms and Conditions
available on GenMark’s website which can be amended from time to time by GenMark without consent.
If Recipient does not accept and agree to be bound by the Terms and Conditions, Recipient will
immediately cease any further use of the instrument.
Trademark and Copyright Statements
Copyright © 2019, GenMark Diagnostics. eSensor®, ePlex®, GenMark®, andGenMark Dx® are registered
trademarks of GenMarkDiagnostics.
Intended Use
The ePlex® instrumentis an automatedin vitro diagnostic device designedto perform multiplexednucleic
acid tests for the simultaneous detection and identification of nucleic acid targets by processing single-
use cartridges developedandmanufacturedby GenMark Diagnostics, Inc.

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Chapter 1. Preface
About thisManual
The ePlex Quick Reference Guide provides instructions how tooperate the ePlex system. The
instructionswithin thismanual assume user hasbasic software computer skills.
Getting Help
For any questions concerning how to setup, use, or maintain theePlexinstrumentthat are notcovered in
this manual, refer to the following availableresources:
ePlex instrumenthelp –Can be accessedfrom the ePlex user interface by selecting the Help
iconon the toolbar:
Package Insert –Information specific to the preparation andperformance of each assay is
locatedat https://www.genmarkdx.com/CustomerResources.
If you are in the United States, contact GenMark Technical Support for additional assistance,
questions, or issues concerning theePlex system. For inquiries or concerns outside the UnitedStates,
contactGenMarkTechnical Supportor your authorized GenMarkrepresentative.
Before contacting GenMark Technical Support please have the following information:
1. Lastfour digitsof the ePlexSerial Number
2. Error Messages (ifapplicable)
United States
GenMark Technical support is available 24 hours a day, 7 days a week to provide the highest level of
customer support and satisfaction.
GenMark Diagnostics, Inc.
5964 La Place Court
Carlsbad, CA 92008
Phone: 1 800 eSensor (1 800 373 6767), Option 2
Email: [e-mail]
International Locations
GenMark Diagnostics Europe
GmbH General-Guisan-Strasse 6
6303 Zug
Switzerland12A
Phone: [phone]
Email: mailto:[e-mail]
Additionally, the Troubleshooting chapter at the end of this manual offers insight into troubleshooting
system issues.

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Chapter 2. Compliance and Safety
General Safety Precautions
Before operating the ePlex system, make sure you read the ePlex operator manual entirely and ensure
you are familiar with the safety information. Operating the ePlex system outside the procedures specified
in the ePlex Operator manual can resultin exposure to hazards that can cause injury to personnel,
damage the system, or adversely impact system performance.
Safety Symbols
Sections markedwith safety symbols contain important safety information for optimal operation of the
ePlex system. Attention tothese advisoriesmaypreventharmtooperator, damage tothe system, or
compromisedtestresults.
Warning: Ahazard or operational warning. Notfollowing the specified directions or guidelines
could result in harm tothe operator, damage tothe system, or compromisedtestresults. Indicates
a possibility of adverse reactions, injury, or death tothe user or other personnel if the precautions
or instructionsare notobserved.
Electrical Warning: A hazard or operational warning. Not following the specified directions
or guidelines could result in harm to the operator including electric shock.
Biohazard Warning: A hazard or operational warning. Not following the specified directions
or guidelines could result in harm to the operator including exposure to biohazardous
material.
Note:A note identifies important details that apply tospecific cases or tasks.
Additional symbols may be used on the ePlex test kits and are explained in the associated Package
Insert.
Symbols Used in the Manual and on ePlex Instrument Labels
In vitro diagnostic medical device
European Union
Conformity
Manufacturer
Authorized
representative in the
European Community
Serial number
Catalog number

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Consult instructions for use
WEEE - Do not throw in
trash
RoHS Directive
ETL Listed Mark
Caution
Biological Risk
Electrical Risk
Note
On
Off
Compliance
The ePlex system has been tested according to the following directives:
Electromagnetic Compatibility (EMC)
CISPR11:2015
IEC EN61326-2-6:2013
Standards
UL 61010-1:2012
UL 61010-2-101
CSA C22.2#61010-1-12:2012
CSA C22.2#61010-2-101:2015
UL 61010-2-010:2015
CSA C22.2#61010-2-010:2015
EN ISO13485:2016
EN ISO14971:2012
EN ISO15223-1:2016

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Warnings andHazards
Follow standardlaboratory precautions when operating the ePlex system. The warnings listed in this
section apply tothe ePlex system anditsaccessories.
GenMark does not take any responsibility for unauthorized modifications to the ePlex system or for
failure of operatingpersonnel toheed the warnings andcautions. Any equipmentused in a manner not
specified in this manual may become unsafe. Review all warnings in this section before operating the
ePlex system.
System Handling Warnings
The ePlex system mustbe assembled, installed, andqualifiedby GenMarkauthorizedpersonnel.
Do notmodify the ePlex system hardware or software withoutwritten authorization from
GenMarkor a GenMark authorizedrepresentative.
Do not addor connect any accessories to theePlex system without authorization from
GenMarkor a GenMark authorizedrepresentative.
Donot attempt repairs or service on theePlex system or accessories withoutauthorization from
GenMarkor a GenMark authorizedrepresentative.
In the eventof an observedleak, contactGenMarkTechnical Support.
Follow all written andon-screen instructions for safe andeffective use of the ePlexsystem.
Only properly trainedpersonnel shouldoperate and perform any repair or service on the ePlex
system.
Do not remove any covers or panels without authorization from GenMark or a GenMark
authorized representative.
For routine surface cleaning, do notspray any fluids directly on the ePlex instrument,
accessories or components.
Donot shutoff main power to the ePlex system while the system is startingor running. Please
use the ePlex software to properlyshutdown or restarttheePlex system .
Use only GenMark approvedcartridges on the ePlex system.
Alwaysbackupcurrent database prior torestoringa new database or purgingdata.
Donotattempttoreuse ePlexcartridges.
Avoidpressing downon the toplabel of the cartridge prior torunningthe cartridge.
When manually startinga run, ensure accession ID isaccurate.
In the case of a software downgrade, data generatedwith the newer software may be lostafter
downgrading. Backupdatabase prior todowngrade.
Restoringa database may result in lostdata on the currently installeddatabase. Ensure you
backupthe current database before restoring the database.
Donot attemptto lift or move the ePlex systemwithout authorization from GenMark or a GenMark
authorized representative.
See original equipmentmanufacturers instructions for safe operation of ePlex accessories.

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Environmental Warnings
Donotoperate the ePlex system outside of the requiredenvironmental specifications.
Donotoperate the ePlex system above elevations of 2000 meters(6,700feet).
Prior topreparingan ePlex instrumentrun, clean all work surfaces with appropriate cleaning
solution.
Donot use the ePlex instrument in close proximity tosources of strong electromagnetic
radiation as these devices may interfere with the ePlex system operation.
Ensure atleast 7.62cm (3") clearance aroundand on topof the ePlex system for adequate
ventilation and cooling.
Cartridge Handling Warnings
Avoidtouchingthe transfer device's tip.Follow assay specific Package Insert.
Donotplace accession IDbarcode outside of the designatedbarcode placement area on
the ePlex cartridge.
Inspectall ePlex cartridges for damage prior touse.
Donotinsert an ePlex cartridge if the cartridge has anysigns of leaks or fluid.
Donotinvert ePlex cartridges after dispensingsample into sample port.
Avoidtouchinginside the sample porton the ePlexcartridge.
Donotattempttoreopen the sample capon the ePlex cartridge after closingthe cap.
Always handle samples cautiously andkeepall samples upright topreventsplashing or spilling.
Biological Hazards
Follow universal precautions for biohazards when handling all samples andwhen performing all
maintenance activities.
Wear safety equipmentor apparel, including gloves, safety glasses, and lab coats when working
with patient samples.
Complete sample transfer in a biosafetyhood.
Treat all samples andcontrols as potentiallyinfectiousmaterial.
Dispose of processedePlex cartridgesas biohazardouswaste uponremoval from the ePlex system.
Donotattempttoopen or disassemble ePlexcartridgesat anytime.
Leaksfrom the ePlex system or cartridgesmay contain biohazardousmaterials.
Consultbiological hazards listedin the ePlex assay Package Insert.
Electrical Hazards
Never touch anyswitches or outletswith wet hands or wetgloves.

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Never disconnectpower connectionsto the ePlex instrumentwhile running.
Perform only maintenance and service procedures in this manual or authorizedby GenMark or
a GenMark authorizedrepresentative.
Donotoperate the ePlex system if any liquidhas leaked inside or on the ePlex systemor cartridge.
Shutdown ePlexsoftware before turningoff frontpower buttonor main power switch.
Turn off the power usingboth the frontpower buttonandrear power switch before
disconnectingthe AC power cord.
Donotplace open liquidcontains on or aroundthe ePlexsystem.
Donotinsert anything other than the ePlex cartridge or testcartridge into the bayon the ePlex
tower.

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Chapter 3.Operation
The workflow for processing a cartridge on the ePlex system includes the following:
1. Applyan accession IDbarcode tothe cartridge matchingthe accession barcode on the primary
sample.
Note: Ensure bothbarcodes match prior totransferring sample.
2. Transfer sample intothe sample porton the cartridge in accordance with the associatedtestpanel
Package Insert.
Note: Sample capis clear enabling user to confirm sample was addedto the cartridge after closing the
cap.
3. Rotate cap90° clockwise andclose the capto seal the cartridge.
4. Scan the cartridge barcodes. Upon successful scan of both the cartridge ID barcode and the
accession ID barcode the scanner will beep once and LED on the scanner will blink green
indicating a successful scan.

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5. Insertcartridge into any ready bay indicated by a blinking white LED. The system will match the
accession ID tothatbay andautomatically starts the run.
6. Uponrun completion,the baywill automatically eject the cartridge andprepare the Detection
Reportfor display, print, or exportusingView Sample Reporton the Bay icon or Bay Details
view.
7. Select View Sample Report to view the detection Report.

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Navigating the User Interface
The ePlex user interface is organizedinto four main views: Run, Reports, Settings andTools.
The default view is the Run view. To move from one screen to the next, select the Navigation icon in the
lower lefthand corner of the toolbar andchoose the desiredview fromthe menu.

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The toolbar is visible at the bottom of the screen in all screen views. The toolbar includes:
1. Navigation icon
2. PendingTestOrdersicon Manual Entryicon
3. Remote icon
4. Helpicon
5. Screen Captureicon
6. Current Usericon
7. Logouticon
8. CurrentDate/Time
9. Restarticon
When applicable, toolbar will include:
10. Bay Errorsicon
11. Alerts icon

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Chapter 4. Using the System
Power on the System
To turn on the ePlex instrument:
1. Ensure the main power switch is in the "On" position indicatedby"-"The main power switch
controlspower to the entire ePlexSystem.
2. Pressthe power buttonon frontof the base toilluminate the switch andturn theePlexinstrumenton.
The frontpower switch controls power to the ePlexintegratedPC.
Note:If theePlex instrumentdoesnotturnon, check the main power switch in the backleftcorner of
the Instrument.

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Electrical Warning: Once the instrumentisrunning, the main power switch in the backleft
corner of the base will shutdown the ePlex instrument immediately. All samples running atthe
time of shutdown will be lost.
Electrical Warning: Turn off the power usingthe frontpower buttonbefore disconnectingthe
ACpower cord.
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 by GenMark or a GenMark authorized representative.
Electrical Warning: Donot operate the ePlex systemif any liquidcouldhave leakedinside or on
the ePlex system orcartridge.
Electrical Warning: Turn off the power usingthe frontpower buttonbefore disconnectingthe
ACpower cord.
Electrical Warning: Do not place open liquid contains on or around the ePlex system.
Electrical Warning: Donot insert anything other than the ePlex cartridge or testcartridge into the
bay sloton the ePlextower.
Logging In
To login to the ePlex instrument:
1. Select the username textbox.
2. Enter the username andselect Enter (alternatively, select the username fromthe drop-down list).
3. Select the passwordtextbox.
4. Enter the passwordandselect Enter. The software will open in the Run view.
OR
When using the barcode scanner, simply scan the user barcode of an active user andyou will be logged
in andthe software will go tothe Run view.
A sample user barcode:

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Note: Username andpasswordare encryptedwithin the user barcode.
Note: Any user can login at any given time without interrupting ongoing runs. TheePlex instrument
does notallow for concurrent userlogins.
Using the Touchscreen
The ePlex graphical user interface allows users to easily navigate through the software simply by
touchingthe screen.
The following guidelines apply when using the touchscreen:
Touch buttons, textboxes andfield headingsonly once; there isno need todouble-touch
anywhere on the ePlexinterface.
Touch delay may occur on certain screens including the Bay Configuration screen as the
ePlex instrumentis gathering information from the bays.
After selecting certain functions you may see the Loading icon please be patientas theePlex
instrumentis processing therequest.
The following multi-touch gestures are enabledwhen viewing reports:
Pan Up
Pan Down
Pan Left
Pan Right
Zoom In
Zoom Out

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To enter information into a specific field, first highlight that field by selectingwithin the textbox.
The on-screen keyboardwill appear, allowing users tobegin enteringtext. Select Enter when
complete.
Select the SHIFTkey todisplay symbols in place of the numberson the on-screen keyboard.
Tohide the on-screen keyboard, touchthe blue Xinthe upper righthandcorner of the
keyboard, touch outside the keyboardor select Esc tohide the keyboard.
Preparing Cartridges
Prepare cartridges according to the procedures detailedin the associatedePlex Panel Package Insert
locatedat https://www.genmarkdx.com/CustomerResources.
The following sections in this manual assume that each cartridge has been properly loadedin compliance
with laboratory standards andsafety protocols.
Before inserting the cartridges into the ePlex instrument, check that they are properly labeled, cap is
closedcompletely and confirm the accession ID barcode on each sample tube andcartridge match.
Starting a Run
A user can start a run by any of the following methods:
1. Manual Entry
2. Barcode Scanner

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3. PendingTestOrders(PTO) Manual Run
Manual Entry
1. Gotothe Run view.
2. Select the Manual Entry icon fromthe toolbar.
3. Enter an accession ID using the on-screen keyboardor barcode scanner andselect Enter.
4. Insertthe cartridge intoany ready bay with a blinkingwhite LED.
Note: Positive sample identification (pos-ID) isnotvalid using the Manual Entry workflow. A flag will
be noted on the Detection Reportstating"Manual start of a sample test"if usingthe Manual Entry
workflow.
Note: Ensure manually entered accession ID isaccurate before startingtest.
Barcode Scanner
1. Gotothe Run view.
2. Scan the cartridge byholdingitunder the barcode scanner.
Note: Boththe customer appliedaccession IDbarcode andthe cartridge IDbarcode are requiredfor a
successful cartridge scan. Scanner will beeponce andLED on the scanner will blinkgreen upon
successful scan of both barcodes.
3. Insertthe cartridge intoany ready bay with a blinkingwhite LED.
Note: Usingthe barcode scanner is the recommendedworkflow on theePlex cartridgeas itmaintains
positive sample identification.
Note: If downloading test orders, upon scanningan accession ID, theePlex instrumentwill checkfor a
matchingpending testorder andstartthe run.
Pending Test Orders (PTO) Manual Run
1. Go to the Run view.
2. Select the Pending Test Orders icon fromthe toolbar.
3. Select an available pendingtestorder from the list.
4. Select Run.
5. Insertthe cartridge intoany ready bay with a blinkingwhite LED.
Note: Positive sample identification isnotvalid using the PTO manual workflow. Aflag will be
noted on the Detection Reportstating"Manual startof a sample test"if using the PTO manual
workflow.

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Using the Barcode Scanner
The barcode scanner can be used to complete the following activities:
1. Login with a User barcode.
2. While onthe Run view, the barcode scanner will simultaneously read the accession ID barcode
andcartridge ID barcode from a cartridge tostarta run.
Note: Tostarta run using the barcode scanner workflow, user mustbe on the Run view.
3. External control barcodes can be generatedby the software andscannedwith the barcode
scanner when runningexternal controlson theePlex instrument.
4. After selecting the Manual Entry icon, the barcode scanner can be usedto enter the Accession ID
(while the on-screen keyboardis visible).
5. User barcodes can be usedtoelectronically sign a report.
6. While onthe Reports >Sample Resultstab, the barcode scanner can be used toenter an
accession IDin the search field.
Barcode Scanning Tips
For effective barcode scanning follow these guidelines:
Ensure roomhas adequate ambientlighting.
Holdthe ePlexcartridge in handwithoutcovering any barcodes.

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Maintain atleast a cartridge length between the bottomof the scanner andthe cartridge.
Move cartridge in a horizontal positionwith arrows pointingtothe backof the ePlexinstrument,
aiming the redcrosshairs for the scan location shown below.
Note:If theePlexinstrumentcannotsuccessfully scan barcodes, refer to starting a run using manual
entry.
Inserting Cartridges into the ePlex Instrument

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Once the ePlexinstrumenthas the information neededtostart a run, the user interface will instruct
the user toenter the cartridge into anyready bay indicatedbyblinkingwhite LEDs.
Insert the cartridge with the label facing up and arrows facing the bay as shown below.
Color Status Indicators
Both the Bay icon andthe bay LEDs on the physical bays will have the following matchingcolor status
indicatorsfor each state.
Color
LED Activity
Status
White
Solid
Read
y
White
Blinking
Insert Cartridge
Blue
Solid
Running
Gree
n
Blinking
Run Complete
Red
Urgent
Blinking
Error
Red
Blinking
OQ Required
Off
N/A
Disabled