illumina MiSeqDx Instrument Installation and operating manual

MiSeqDxInstrument
SafetyandComplianceGuide
ILLUMINAPROPRIETARY
Document#15034477v05
Nov2021
FORINVITRODIAGNOSTICUSE

This documentanditscontentsareproprietarytoIllumina,Inc.anditsaffiliates("Illumina"),andareintendedsolely
forthecontractualuseofitscustomerinconnectionwiththeuseoftheproduct(s)describedhereinandfornoother
purpose.Thisdocumentanditscontentsshallnotbeusedordistributedforanyotherpurposeand/orotherwise
communicated,disclosed,orreproducedinanywaywhatsoeverwithoutthepriorwrittenconsentofIllumina.Illumina
doesnotconveyanylicenseunderitspatent,trademark,copyright,orcommon-lawrightsnorsimilarrightsofany
thirdpartiesbythisdocument.
Theinstructionsinthisdocumentmustbestrictlyandexplicitlyfollowedbyqualifiedandproperlytrainedpersonnel
inordertoensuretheproperandsafeuseoftheproduct(s)describedherein.Allofthecontentsofthisdocument
mustbefullyreadandunderstoodpriortousingsuchproduct(s).
FAILURETOCOMPLETELYREADANDEXPLICITLYFOLLOWALLOFTHEINSTRUCTIONSCONTAINEDHEREINMAY
RESULTINDAMAGETOTHEPRODUCT(S),INJURYTOPERSONS,INCLUDINGTOUSERSOROTHERS,ANDDAMAGE
TOOTHERPROPERTY,ANDWILLVOIDANYWARRANTYAPPLICABLETOTHEPRODUCT(S).
ILLUMINADOESNOTASSUMEANYLIABILITYARISINGOUTOFTHEIMPROPERUSEOFTHEPRODUCT(S)
DESCRIBEDHEREIN(INCLUDINGPARTSTHEREOFORSOFTWARE).
©2021Illumina,Inc.Allrightsreserved.
AlltrademarksarethepropertyofIllumina,Inc.ortheirrespectiveowners.Forspecifictrademarkinformation,see
www.illumina.com/company/legal.html.
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RevisionHistory
Document# Date DescriptionofChange
15034477v05 November
2021 Addedstatementforindooruseonly.
RemovedoldR&TTEdirective.
AddedEMCConsiderations,FCCCompliance,and
ICCompliancestatements.
AddedcompliancestatementsforBrazil,Korea,
Thailand,Mexico,andUnitedArabEmirates.
15034477v04 August
2021 UpdatedEUAuthorizedRepresentativeaddress.
15034477v03 December
2019 UpdatedEUAuthorizedRepresentativeaddress.
UpdatedAustralianSponsoraddress.
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Document# Date DescriptionofChange
15034477v02 January
2017 UpdatedtheFCCEMCconsiderationsregarding radiointerferenceinadomesticenvironment.
Addedthefollowingcompliancedirectives:
•RoHS2011/65/EU
•RadioEquipmentDirective2014/53/EU
Updatedthefollowingcompliancedirectives:
•EMC
•LowVoltage
UpdatedtheHumanExposuretoRadioFrequency
compliancestatement.
Addedacompliancestatementonemissionand
immunityrequirementsintheEMCConsiderations
section.
Removedsomecompliancedirectives,astheyare
nowavailableat
support.illumina.com/certificates.html.
RemovedtheComplianceandRegulatoryMarkings
section.
Addedastatementonradiointerferencetothe
KoreaCompliancesection.
AddedtranslationsinChinese,German,Spanish,
Norwegian,French,andItalian.
AddedAustraliasponsorinformationtotheback
cover.
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Document# Date DescriptionofChange
15034477v01 October
2015 Updatedregulatorymarkingsonthebackcover.
Addedarevisionhistory.
ReorderedsectionsoftheguideintoaProduct
ComplianceandRegulatoryStatementschapter.
Notedthatdateofmanufactureandcountryof
originareontheinstrumentlabel.
AddedcompliancestatementsforBrazil,Korea,and
Mexico.
MadethefollowingchangestotheComplianceand
RegulatoryMarkingssection:
•AddedKoreamark
•RemovedtheFCCmark
AddedR&TTEDirective1999/5/ECtotheProduct
CertificationsandCompliancesection.
Removedinformationonshieldedcables.
AddedasectiononethernetcablesandonEMC
considerations.
Revisedthehazardousvoltagesourcelocationfrom
theleftsidepaneltotherightsidepanelonthe
electricalsafetywarningnote.
Part#15034477Rev.
AFebruary 2014 InitialRelease
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TableofContents
RevisionHistory iii
Introduction 1
SafetyConsiderationsandMarkings 2
GeneralSafetyWarnings 2
ElectricalSafetyWarnings 3
HotSurfaceSafetyWarning 4
HeavyObjectSafetyWarning 4
Uncrating,Installing,andMovingtheInstrument 4
EnvironmentalConstraints 5
Symbols 6
ProductComplianceandRegulatoryStatements 7
ProductCertificationsandCompliance 7
RestrictionofHazardousSubstances(RoHS) 7
HumanExposuretoRadioFrequency 7
FCCCompliance 7
ICCompliance 9
ConformitéIC 9
BrazilCompliance 10
KoreaCompliance 10
Españolesadvertencia-Mexico 10
ThailandCompliance 10
UnitedArabEmiratesCompliance 10
TechnicalAssistance 11
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Introduction
Thisguideprovidesimportantsafetyinformationpertainingtotheinstallation,servicing,andoperation
oftheMiSeqDx,aswellasproductcomplianceandregulatorystatements.Readthisdocumentbefore
performinganyproceduresontheMiSeqDx.
TheMiSeqDxcountryoforiginanddateofmanufactureareprintedontheinstrumentlabel.
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SafetyConsiderationsandMarkings
Thepurposeofthissectionistoidentifythepotentialhazardsassociatedwithinstalling,servicing,and
operatingtheMiSeqDxinstrument.Donotoperateorinteractwiththeinstrumentinamannerthat
exposesyoutoanyofthesedangers.
Hazardsindicatedbylabelsontheinstrumentarepicturedinthissection.
Allofthehazardsdescribedcanbeavoidedbyfollowingthestandardoperatingproceduresincludedin
theMiSeqDxinstrumentreferenceguide.
MiSeqDx
Instrument
Type InstrumentReferenceGuide
MOSv1 MiSeqDxReferenceGuideforInstrumentswithDualBootConfiguration(document#
15070067)—ForMiSeqDxinstrumentswithdualbootconfigurationwithMOSv1.
MOSv2 MiSeqDxInstrumentReferenceGuideforMOSv2(document#1000000021963)—For
MiSeqDxinstrumentswithMiSeqDxOperatingSoftware(MOS)v2.(Allinstruments
withMOSv2havedualbootconfiguration.
MOSv4 MiSeqDxInstrumentReferenceGuideforMOSv4(document#200010452)—For
MiSeqDxinstrumentswithMiSeqDxOperatingSoftware(MOS)v4.(Allinstruments
withMOSv4havedualbootconfiguration.)
GeneralSafetyWarnings
BeforeoperatingtheMiSeqDx,allpersonnelmustbetrainedbyIlluminainthecorrectoperationofthe
instrumentandanypotentialsafetyconsiderations.
CAUTION
TrainedIlluminapersonnelmustperformallserviceandmaintenancetasksthatarenot
describedintheMiSeqDxInstrumentReferenceGuideforMOSv4(document#200010452).
CAUTION
Followalloperatinginstructionsasdocumentedwhenworkinginareasmarkedwiththislabel
tominimizepersonalorinstrumentrisk.
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ElectricalSafetyWarnings
Donotremovetheouterpanelsfromtheinstrument.Therearenouser-serviceablecomponents
inside.Operatingtheinstrumentwithanyofthepanelsremovedcreatespotentialexposuretoline
voltageandDCvoltages.
Theinstrumentispoweredby100–240voltsACoperatingateither50Hzor60
Hz.Hazardousvoltagesourcesarelocatedbehindtherightsidepanel,butcan
beaccessibleifotherpanelsareremoved.Somevoltageispresentonthe
instrumentevenwhentheinstrumentispowereddown.Operatetheinstrument
withallpanelsintacttoavoidelectricalshock.
PowerSpecifications
Type Specification
LineVoltage 100–240VoltsAC@50/60Hz
PowerConsumption 400Watts
ElectricalConnections
PlugtheMiSeqDxintoagroundedcircuitcapableofdeliveringatleast:
•10Ampsfora100–110Vpowersource
•6Ampsfora220–240Vpowersource
Formoreinformation,seetheMiSeqDxInstrumentSitePreparationGuide(document#15070066).
ProtectiveEarth
Theinstrumenthasaconnectiontoprotectiveearththroughtheenclosure.The
safetygroundonthepowercordreturnsprotectiveearthtoasafereference.The
protectiveearthconnectiononthepowercordmustbeingoodworkingcondition
whenusingthisdevice.
Fuses
Theinstrumentcontainsnouser-replaceablefuses.
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HotSurfaceSafetyWarning
DonotoperatetheMiSeqDxwithanyofthepanelsremoved.
Donottouchtheflowcellstageintheflowcellcompartment.ThePeltiereffect
heaterusedinthestageareaisnormallycontrolledbetweenambientroom
temperature(22°C)and95°C.Exposuretotemperaturesattheupperendofthis
rangecanresultinburns.
HeavyObjectSafetyWarning
Theinstrumentweighsapproximately57kg(126lb)andcancauseseriousinjury
ifdroppedormishandled.
Uncrating,Installing,andMovingtheInstrument
OnlyIllumina-authorizedpersonnelshoulduncrate,install,ormovetheMiSeqDx.Iftheinstrument
mustberelocated,contactIlluminaCustomerSupporttoarrangeaservicevisit.
Forcontactinformation,seeTechnicalAssistance.
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EnvironmentalConstraints
Forindooruseonly.
Element Specification
Temperature TransportationandStorage:-10°Cto40°C(14°Fto104°F)
OperatingConditions:19°Cto25°C(66°Fto77°F)
Humidity TransportationandStorage:Non-condensinghumidity
OperatingConditions:30–75%relativehumidity(non-condensing)
Elevation Locatetheinstrumentatanaltitudebelow2000meters(6500feet).
AirQuality OperatetheinstrumentinaPollutionDegreeIIenvironmentorbetter.A
PollutionDegreeIIenvironmentisdefinedasanenvironmentthat
normallyincludesonlynonconductivepollutants.
Ventilation Consultyourfacilitiesdepartmentforventilationrequirementsbased
ontheinstrumentheatoutputspecifications.
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SymbolsForinvitrodiagnosticuse
EuropeanRepresentative
ManufacturedBy
DateofManufacture
ModelNumber
SerialNumber
Off
On
HumidityRange(onpackaging:indicatesacceptableshippingandstorage
limits)
TemperatureRange(onpackaging:indicatesacceptableshippingand
storagelimits)
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ProductComplianceandRegulatory
Statements
ProductCertificationsandCompliance
HerebyIlluminadeclaresthattheMiSeqDxisincompliancewiththefollowingdirectives:
•EMC2014/30/EU
•IVD98/79/EC
•LowVoltage2014/35/EU
•RadioEquipment2014/53/EU
•RoHS2011/65/EUanditsamendments
ThefulltextoftheEUdeclarationsofconformityandcertificatesofcomplianceareavailable
at:support.illumina.com/certificates.html.
RestrictionofHazardousSubstances(RoHS)
Thislabelindicatesthattheinstrumentshouldnotbedisposedwithcommonmunicipal
waste.
ReturntheinstrumenttoIlluminafordisposal.
HumanExposuretoRadioFrequency
Thisequipmentcomplieswithmaximumpermissibleexposure(MPE)limitsforthegeneralpopulation
perTitle47CFR§1.1310Table1.
Thisequipmentcomplieswiththelimitationofhumanexposuretoelectromagneticfields(EMFs)for
devicesoperatingwithinthefrequencyrange0Hzto10GHz,usedinradiofrequencyidentification
(RFID)inanoccupationalorprofessionalenvironment.(EN50364:2010sections4.0.)
FCCCompliance
ThisdevicecomplieswithPart15oftheFCCRules.Operationissubjecttothefollowingtwoconditions:
1. Thisdevicemaynotcauseharmfulinterference.
2. Thisdevicemustacceptanyinterferencereceived,includinginterferencethatmaycause
undesiredoperation.
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CAUTION
Changesormodificationstothisunitnotexpresslyapprovedbythepartyresponsiblefor
compliancecouldvoidtheuser’sauthoritytooperatetheequipment.
NOTE ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassAdigital
device,pursuanttoPart15oftheFCCrules.Theselimitsaredesignedtoprovide
reasonableprotectionagainstharmfulinterferencewhentheequipmentisoperatedina
commercialenvironment.
Thisequipmentgenerates,uses,andcanradiateradiofrequencyenergyand,ifnot
installedandusedinaccordancewiththeinstrumentationmanual,maycauseharmful
interferencetoradiocommunications.Operationofthisequipmentinaresidentialareais
likelytocauseharmfulinterferenceinwhichcaseuserswillberequiredtocorrectthe
interferenceattheirownexpense.
EthernetCables
UseaCAT-5eunshieldedethernetcabletoensurecompliancewithCISPR11ClassAemissionslimits.
EMCConsiderations
ThisIVDmedicalequipmentcomplieswiththeemissionandimmunityrequirementsdescribedinIEC
61326-2-6.
ThisequipmenthasbeendesignedandtestedtotheCISPR11ClassAstandard.
Thisequipmentisnotintendedforuseinresidentialenvironmentsandmaynotprovideadequate
protectiontoradioreceptioninsuchenvironments.
Electromagneticenvironmentshouldbeevaluatedpriortooperationofthedevice.
Donotusethisdeviceinproximitytosourcesofstrongelectromagneticradiation(e.g.unshielded
intentionalRFsources),asthesecaninterferewithproperoperation.
Thisequipmentisdesignedforuseinaprofessionalhealthcarefacilityenvironment.Itislikelyto
performincorrectlyifusedinahomehealthcareenvironment.Ifitissuspectedthatperformanceis
affectedbyelectromagneticinterference,correctoperationmayberestoredbyincreasingthedistance
betweentheequipmentandthesourceoftheinterference.
Changesormodificationsnotexpresslyapprovedbythepartyresponsibleforcompliancecouldvoid
theuser’sauthoritytooperatetheequipment.
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ICCompliance
ThisClassAdigitalapparatusmeetsallrequirementsoftheCanadianInterference‐Causing
EquipmentRegulations.
ThisdevicecomplieswithIndustryCanadalicence‐exemptRSSstandards.Operationissubjecttothe
followingtwoconditions:
1. Thisdevicemaynotcauseinterference.
2. Thisdevicemustacceptanyinterference,includinginterferencethatmaycauseundesired
operationofthedevice.
UnderIndustryCanadaregulations,thisradiotransmittermayonlyoperateusinganantennaofatype
andmaximum(orlesser)gainapprovedforthetransmitterbyIndustryCanada.
Toreducepotentialradiointerferencetootherusers,theantennatypeanditsgainshouldbeso
chosenthattheequivalentisotropicallyradiatedpower(e.i.r.p.)isnotmorethanthatnecessaryfor
successfulcommunication.
Thisradiotransmitter(ICID:9859A-MISEQ)hasbeenapprovedbyIndustryCanadatooperatewith
theantennatypeslistedbelowwiththemaximumpermissiblegainandrequiredantennaimpedance
foreachantennatypeindicated.Antennatypesnotincludedinthislist,havingagaingreaterthanthe
maximumgainindicatedforthattype,arestrictlyprohibitedforusewiththisdevice.
Allowableantenna:InternalLoopantenna
ConformitéIC
LedispositifnumériqueClasseArépondàtouteslesexigencesdesRèglementscanadienssurle
matérielbrouilleur.
LeprésentappareilestconformeauxCNRdʹIndustrieCanadaapplicablesauxappareilsradioexempts
delicence.Lʹexploitationestautoriséeauxdeuxconditionssuivantes:
1. Lʹappareilnedoitpasproduiredebrouillage.
2. Lʹutilisateurdelʹappareildoitacceptertoutbrouillageradioélectriquesubi,mêmesilebrouillageest
susceptibledʹencompromettrelefonctionnement.
ConformémentàlaréglementationdʹIndustrieCanada,leprésentémetteurradiopeutfonctionner
avecuneantennedʹuntypeetdʹungainmaximal(ouinférieur)approuvépourlʹémetteurparIndustrie
Canada.
Danslebutderéduirelesrisquesdebrouillageradioélectriqueàlʹintentiondesautresutilisateurs,il
fautchoisirletypedʹantenneetsongaindesortequelapuissanceisotroperayonnéeéquivalente
(p.i.r.e.)nedépassepaslʹintensiténécessaireàlʹétablissementdʹunecommunicationsatisfaisante.
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Leprésentémetteurradio(ICID:9859A‐MISEQ)aétéapprouvéparIndustrieCanadapourfonctionner
aveclestypesdʹantenneénumérésci‐dessousetayantungainadmissiblemaximaletlʹimpédance
requisepourchaquetypedʹantenne.Lestypesdʹantennenoninclusdanscetteliste,oudontlegainest
supérieuraugainmaximalindiqué,sontstrictementinterditspourlʹexploitationdelʹémetteur.
BrazilCompliance
ConformidadeANATEL:
EsteequipamentofoitestadoeestáemconformidadecomasresoluçõesdaANATEL442e506.
Esteequipamentooperaemcarátersecundário,istoé,nãotemdireitoaproteçãocontrainterferência
prejudicial,mesmodeestaçõesdomesmotipo,enãopodecausarinterferênciaasistemasoperando
emcaráterprimário.
KoreaCompliance
해당 무선 설비는 운용 중 전파 혼신 가능성이 있음.
A급 기기(업무용 방송통신기자재)
이 기기는 업무용(A급)으로 전자파적합로서 판매자 또는 사용자는 이 점을 주의 하시기 바라며,가정외의 지역에서
사용하는 것을 목 적으로 합니다.
Españolesadvertencia-Mexico
ConformidadconInstitutoFederaldeTelecommunicaciones
Laoperacióndeesteequipoestásujetaalassiguientesdoscondiciones:
1. Esposiblequeesteequipoodispositivonocauseinterferenciaperjudicial.
2. Esteequipoodispositivodebeaceptarcualquierinterferencia,incluyendolaquepuedacausarsu
operaciónnodeseada.
ThailandCompliance
ThistelecommunicationequipmentconformstotherequirementsoftheNationalTelecommunications
Commission.
UnitedArabEmiratesCompliance
•TRARegisteredNumber:ER0117765/13
•DealerNumber:DA0075306/11
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TechnicalAssistance
Fortechnicalassistance,contactIlluminaTechnicalSupport.
Website: www.illumina.com
Email: [e-mail]
IlluminaTechnicalSupportTelephoneNumbers
Region TollFree International
Australia [phone]
Austria [phone] [phone]
Belgium [phone] [phone]
Canada [phone]
China [phone]
Denmark [phone] [phone]
Finland [phone] [phone]
France [phone] [phone]
Germany [phone] [phone]
HongKong,China [phone]
India [phone]
Indonesia 0078036510048
Ireland [phone] +35316950506
Italy [phone] [phone]
Japan [phone]
Malaysia [phone]
Netherlands [phone] [phone]
NewZealand [phone]
Norway [phone] [phone]
Philippines [phone]
Singapore 18005792745
SouthKorea [phone]
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Region TollFree International
Spain [phone] [phone]
Sweden [phone] [phone]
Switzerland [phone] [phone]
Taiwan,China [phone]
Thailand [phone]
UnitedKingdom [phone] [phone]
UnitedStates [phone] [phone]
Vietnam [phone]
Safetydatasheets(SDSs)—AvailableontheIlluminawebsiteatsupport.illumina.com/sds.html.
Productdocumentation—Availablefordownloadfromsupport.illumina.com.
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