GenMark Dx ePlex User manual

PI1067- Rev. F 1
Quick ReferenceGuide

PI1067- Rev. F 2
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.