Clarity Platinum User manual

®
Clarity Planum Urine Analyzer
Operator’s Manual
We Support Beer Outcomes™

1. INTRODUCTION ................................................................................................... 1
Intended Use ...................................................................................................................... 1
 GengStarted ................................................................................................................... 2
 UnpackingtheClarityPlanumUrineAnalyzer.................................................................. 2
 ClarityPlanumUrineAnalyzerHardwareOverview......................................................... 2
 AssemblingtheClarityPlanumUrineAnalyzer ................................................................ 3
 LoadingthePrinterRoll ...................................................................................................... 4
 PoweringOn/O................................................................................................................. 5
 AccessingtheMainMenu .................................................................................................. 6
 ClarityPlanumUrineAnalyzerUserInterface .................................................................. 7
2. OPERATIONS ....................................................................................................... 8
2.1 PERFORMING A URINALYSIS TEST .................................................................. 9
 PreparingaUrinalysisTest.................................................................................................. 9
 PerformingaUrinalysisTest ............................................................................................. 10
 ViewingtheUrinalysisTestResult .................................................................................... 10
 PrinngtheUrinalysisTestResult..................................................................................... 11
 ComplengtheUrinalysisTest ......................................................................................... 11
3. TEST RESULTS MANAGEMENT ............................................................................ 12
 RecallAllResults ............................................................................................................... 12
 SearchResultsbyID.......................................................................................................... 12
 SearchResultsbyDate ..................................................................................................... 13
 DeleteResults................................................................................................................... 13
4. SYSTEM CONFIGURATION .................................................................................. 14
4.1 BASIC SETTINGS ............................................................................................. 14
 StripType.......................................................................................................................... 14
 Language .......................................................................................................................... 14
 Date&Time...................................................................................................................... 14
 UnitSeng....................................................................................................................... 15
 PrinterSeng................................................................................................................... 15
 SystemInformaon .......................................................................................................... 15
 RestoreDefaultSeng..................................................................................................... 15
(Connued on next page.)
WeSupportBeerOutcomes™
Table of Contents

4.2 ADVANCED SETTINGS .................................................................................... 16
 Operator ........................................................................................................................... 16
 TestMode......................................................................................................................... 16
 QualityControl ................................................................................................................. 16
 PerformaQualityControlTest ......................................................................................... 18
4.3 DEVICE DIAGNOSTICS .................................................................................... 20
5. TROUBLESHOOTING ........................................................................................ 21
 FailureModeErrorMessageandCorrecveAcon......................................................... 22
6. MAINTENANCE ................................................................................................ 28
 RemovingandReplacingtheStripBed............................................................................. 28
 Daily/RouneCleaningoftheStripBed ........................................................................... 29
 WeeklyCleaningoftheStripBed ..................................................................................... 29
 CleaningtheAnalyzerCase............................................................................................... 29
 CleaningtheTouchScreen................................................................................................ 29
APPENDIX A. Clarity Planum Urine Analyzer Specicaons .................................. 30
APPENDIX B. Clarity Planum Urine Analyzer Default Sengs ............................... 30
APPENDIX C. Clarity Planum Urine Analyzer Unit Convenon Table ..................... 31
APPENDIX D. Symbols ............................................................................................ 33
WeSupportBeerOutcomes™
Table of Contents

WeSupportBeerOutcomes™
Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
Page1
1. Introducon
Theintroduconexplainshowtounpack,install,andbeginusingtheClarity
PlanumUrineAnalyzer.Theintroduconalsoincludesanoverviewofthe
analyzeranditskeyfeatures.
TheClarityPlanumUrineAnalyzerTestSystemisforCLIAWaivedUseand
onlytobeusedwithClarityDiagnosc’sUrineReagent(CLA-10P)Strips.This
testiswaivedundertheCLIA’88regulaons.Thistestisonlywaivedforurine
specimens,andfailuretoadheretotheinstruconsforusewillresultinthe
testbeingconsideredhighcomplexityandsubjecttoallCLIArequirements.
ACLIACercateofWaiverisrequiredtoperformthistest.ACercateof
WaivercanbeobtainedfromtheCentersforMedicare&MedicaidServices
(CMS).Visitwww.cms.govtoobtainanapplicaon(FormCMS-116).Youmust
followthemanufacturer’sinstruconstoperformtests.Youshouldreadthe
completetestprocedurebeforeperformingthetest.
Intended Use
TheClarityPlanumanalyzerisabenchtopanalyzerdesignedtoreadClarity’s
proprietaryurinalysisstrips(CLA-10P).Theinstrumentisintendedtobe
usedtogetherwithClarityDiagnoscs’UrineReagentStripsasasystemfor
semi-quantavedeteconofGlucose,Bilirubin,Ketone,SpecicGravity,
Blood,pH,Protein,Urobilinogen,NitriteandLeukocytesinurine.These
measurementsareusedtoaidinthediagnosisofmetabolicdisorders,
kidneyfunconanomalies,urinarytractinfecons,andliverfuncon.
TestsperformedbytheClarityPlanumanalyzerareintendedforin vitro
diagnoscuseonly.

Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
WeSupportBeerOutcomes™Page2
Geng Started
Unpacking the Clarity Planum
TheClarityPlanumanalyzerisdeliveredinonebox.Tounpacktheanalyzer,
carefullyremoveallcomponentsfromtheboxandinspectforanysignsof
damage.Iftheanalyzerappearstobedamaged,immediatelycontactyour
shippingcarrierandClarityDiagnoscs.Eveniftheboxappearstobedamaged,
thedevicecanbepreservedduetotheinternalpackaging.Verifythatyouhave
eachofthefollowingcomponents:
• ClarityPlanumAnalyzer
•ThermalPrinterPaper(preloadedinanalyzer)
•PowerSupplyAdaptorwithACPowerCord
•ClarityPlanumManual
• QuickStartOperator’sManual
• BarcodeReader
Ifyouaremissinganycomponents,pleasecontactClarityDiagnoscs
immediatelyat(877)485-7877,Monday-Friday,8am-6pmEST.
Clarity Planum Urine Analyzer Hardware Overview
TheClarityPlanumconsistsofthefollowinghardwarecomponents:
•TouchScreenDisplay
• TestStripBed
•Printer
•PowerCord
• ConneconPorts

WeSupportBeerOutcomes™
Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
Page3
Figure 1. Clarity Planum
1. Touch Screen Display
2. Test Strip Bed
3. USB-A Port, Barcode Reader
4. USB-C Port, Data Transfer
5. Power Cord (DC IN)
6. Power Switch
7. Printer Cover
Assembling the Clarity Planum
1. PlacetheClarityPlanumanalyzeronalevelsurfaceawayfrom
  sourcesofheatandliquids.TheClarityPlanumanalyzerperforms
  opmallybetween59°-86°F(18–30°C).
2. Removethebarcodereaderfromtheboxandconnectittothe
  USB-APortonthebackofyouranalyzerwhereitislabeled
  ‘BarcodeReader’.(Figure1,number3)
3. Plugthepowersupplyadaptorcordintothebackoftheanalyzer
  whereitislabeled‘DCIN’.(Figure1,number5)
4. Connectthepowersupplyadaptorcordintoa120VACwalloutlet.
1
23 4 5 6 7

Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
WeSupportBeerOutcomes™
Figure 2. Printer
Loading the Printer Roll
1. Opentheprintercoverbygentlyliingtheexternaltablocatedatthe
  backoftheanalyzerupwardandliingthefrontpinsoutoftheirslots
  inthefront.Setasidethecover.
2. MakesuretheClarityPlanumispluggedinfortheautomacpaper
  feedtofuncon.
3. Placetherollofthermalpaperinthecradleatthebackofthemachine,
  withtheshinysideofthepaperfacingthefrontofthemachine.
4. Feedtheendofthethermalpaperrollintotheboomoftheblack
  rollerunlitiscaughtbytheauto-feedandpulledintotheroller.
5. Gentlyreplacetheprintercoverbyhookingtheplascfrontpinsrst,
  withtheClarityDiagnoscslogofacingthefrontofthemachine.
  Feedthepaperfromtheblackrollerthroughtheslotwiththe
  perforatededgeonthecover,andthenpushtheexternaltabdown
  thebackofthemachineunlthecoverisbackinplace.
Page4

WeSupportBeerOutcomes™
Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
Page5
Powering On/O
To Power On the Clarity Planum Analyzer:
1. Pressthepowerswitchlocatedonthebackoftheunit.
  (Figure1,number6)
2. TheClarityPlanumwillperformsystemdiagnoscseachmethe
  unitispoweredon,whichchecksthattheopcal,electronic,and
  mechanicalsystemsareperformingasexpected.Ifthesystem
  diagnoscsaresuccessful,theprinterwillautomacallyprint:
  ‘SystemDiagnoscsOK.ReadytoUse’,andthemainmenu
  screenwillappear.
3. Ifanerroroccursduringinializaon,theanalyzerwilldisplaya
  ‘SystemCalibraonFailed’errormessageandtwooponswill
  appearonscreen,‘Recalibrate’or‘TechnicalSupport.’
4. Presstherecalibratebuontorerunsystemdiagnoscs.Iftheerror
  persists,pleasecontactClarityDiagnoscsTechnicalSupportat
  (877)485-7877,Monday-Friday,8am-6pmEST.
To Power O the Clarity Planum Analyzer:
1. Ensurethatthestripbedisemptyandthatnotestsareinprogress.
2. Usewarmwaterandacoonswabtocleanthestripbed.
3. Pressthepowerswitchlocatedonthebackoftheunittoturnothe
  analyzer.Pressingthepowerswitchwillalsoautomacallyretractthe
  stripbedintothemachine.(Figure1,number6)

Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
WeSupportBeerOutcomes™Page6
Figure 3. Clarity Planum Main Menu
From the main menu, you may select:
1. Test Strip
  Thiswillbringyoutotheurinesampletest.
2. Results
  FromtheResultspageyou,canrecallpreviousresultsandsearchstored
  testresultsbasedonDate,PaentIDandTestID.
3. Sengs
  Inthissecon,youcanaccesssengsforstriptype,displaylanguage,
  date&me,andenable/disabletheautomacprinngfeatureandformat.
  Youcanalsoviewsysteminformaon.
  TheRestore Default SengfunconisforClarityDiagnoscs
  administratorsonlyandrequiresavalidadministratorpasswordforaccess.
4. Advanced
  TheAdvanced sengsmenuisaccessibletoalloperators.TheCLIA
  Waivedoperatorcanperformfunconslikequalitycontroltesng,system
  diagnoscs,andstripbedmaintenance.Moreadvancedfeatures,like
  addingauthorizedoperators,modifyingoperatorpermissions,modifying
  qualitycontrolsengs,selecngtestmode,andenablingordisabling
  barcodescanning,areintendedforClarityDiagnoscsadministratorsonly
  andrequireavalidadministratorpasswordforaccess.
Note: The strip bed can be retracted from the Strip Bed Device Maintenance
secon of the Advanced sengs menu. Retracng the strip bed can prevent
damage to the Planum while not in use. Full instrucons can be found in
Secon 6: Removing/Replacing Strip Bed.
Accessing the Main Menu
AerturningontheClarityPlanum
analyzer,thesystemdiagnoscswill
runautomacally,andthemachine
willbringyoutothemainmenu.

WeSupportBeerOutcomes™
Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
Page7
Clarity Planum User Interface
TheClarityPlanumanalyzerusesatouchscreentodisplayuseropons,
results,sengs,anddiagnoscs.Thetouchscreenisusedforalluserinput.
Thebarcodereaderaachmentcanalsobeusedforinpungbarcodesfrom
theteststriporcontrolboles,aswellaspaentIDs.(SeeSecon 4.2:
Advanced Sengs)
Do not use any sharp or pointed objects on the screen, as they may damage
the display.
To Operate the Clarity Planum Analyzer:
• PresstheTest Stripicondisplayedonthescreento
  runaUrineTestStrip.
• Scanorenterthebarcodefromthestripboleandpressenter.
• ScanorenterthePaentID,orskipitbypressingenter.
• FollowtheinstruconsintheQuickStartGuidetoperformatest.
• Presstheback/returnbuonontheboomleofthescreen
  toreturntothemainmenu.

Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
WeSupportBeerOutcomes™Page8
2. Operaons
By pressing the Test Strip buon on the main menu screen, you can perform
a urinalysis test.
Note: The Barcode Reader feature has been enabled (default conguraon)
and you will be prompted to scan or enter the barcode on the test strip bole
prior to reaching the Test Preparaon screen.
Entering Strip Barcode Informaon
ToentertheStripBarcodeinformaon,performthefollowingsteps:
1. Aerpressingthe Test Stripbuon,usethekeypadonthescreenor
  theClarityPlanumbarcodescannertoenterthebarcodefromthe
  CLA-10Pbole.
2. Aerenteringthebarcode,pressEnter toproceedtothenextstep.
Note: Test known posive and negave specimens/controls at each of the
following events in accordance with local, state, and/or federal regulaons or
accreditaon requirements. For CLIA Waived sengs, Clarity Urinalysis Quality
Controls must be tested under the following condions:
• When a new canister of strips is opened OR
• Test results appear to be inaccurate OR
• A new operator uses the analyzer OR
• Each new day of tesng OR
• Aer performing maintenance or service on the analyzer.
(See Secon 4.2: Advanced Sengs, Quality Control)

WeSupportBeerOutcomes™
Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
Page9
2.1 Performing a Urinalysis Test
Pressing the Test Strip buon on the main menu screen will bring you directly
to the main tesng screen.
Note: You will be prompted to scan or enter the barcode on the test strip bole
prior to reaching the test preparaon screen.
Preparing a Urinalysis Test
1. Collectaurinesample,aCLA-10Purineteststrip,apapertowel,and
  havetheanalyzerready.
2. AerpressingtheTest Stripbuon,usetheClarityPlanumscanneror
  thekeypadonthescreentoenterthebarcodefromtheCLA-10Purine
  reagentstripbole.
3. Next,theanalyzerwillpromptyouforaPaentID.Youcanusethe
  scannerorkeypadtoinputthatinformaon,followedbyEnter,or
  selectEntertoskip.
4. The Preparing Test screenwillappearandpromptyoutoperformthe
  followingaconsbeforepressingtheStartbuon:
 • Checktheexpiraondateontheteststripbole.Discardifit
  isexpired.
 •Removetheteststripfromtheboleandreplacethecap.
 • Dipthestripintotheurinesample.
 • PressStarttobeginthetest.
5.PressHelptoaccessmoredetailedinstrucons.Atanyme,youmay
  returntothemainmenubypressingthebuon.
Biohazard:
Wearpersonalprotecveequipmentwhenhandlingthe
paentspecimenandperformingthetest.Useuniversal
precauonsforanybiohazardmaterials.

Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
WeSupportBeerOutcomes™Page10
Performing a Urinalysis Test
1. Dipthestripintotheurinesampleandremoveitimmediately.
  Ensurethatallpadsonthestriparesaturatedwiththeurinesample.
  Whileyouaredoingthis,presstheStartbuon.
2. AerpressingtheStartbuon,theanalyzerbegins10secondsof
  self-calibraon.Duringthisme,touchthelongedgeofthestriponto
  apapertoweltoremovetheexcessurine,andplacethestriponthe
  stripbedwiththetestpadsfacingup.Ensurethattheteststripis
  insertedfullyintothebackofthestripbed.Thedippingstepshould
  notexceed10seconds.
3. Whencalibraoniscomplete,theanalyzerretractsthestripbed
  withthestrip,anditwillbeginanalysis.
4. Ameronscreenwillcountdownthemeremaininginthestrip
  analysisprocess.
Note: You cannot cancel a test before the analyzer nishes the test.
Viewing the Urinalysis Test Result
1. Aerthecountdownends,theanalyzerdisplaysthetestresulton
  thescreen.
2. PresstheResultsbuontoaccessthestoredresults,orpressthe
Next Testbuontoperformanothertest.
Cauon:
DONOTpushorpullthestripbedormovetheanalyzer
duringthetest.Itmightcausetheanalyzertofailcalibraon.

WeSupportBeerOutcomes™
Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
Page11
Prinng the Urinalysis Test Result
Oncethetestiscompleted,thetestresultisprintedautomacallyifthe
machineisinthedefaultseng.Thetestresultsprintoutcouldincludeany
ofthefollowinginformaon,dependingonthesengs:
• OperatorID
• PaentID
• TestID
Youcanchangetheprintersengtomanualortheprintoponsinthe
Printer Sengmenu,asdescribedinSecon 4.1: Basic Sengs.
Compleng the Urinalysis Test
1. Removetheteststripfromthestripbedanddisposethestrip
  accordingtoyourlocal,state,andfederalguidelines.
2. Cleanthestripbedusingasoluonofsodiumhypochlorite
  525-615ppm(diluon1:100of5.25-6.15%sodiumhypochlorite)
  or70%isopropylalcoholwithacoonswab.
3. SelectResultstoviewthestoredresults,orselectNext Test to
  performthenexttest.
4.Youmayreturntothemainmenubypressingthebuon.

Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
WeSupportBeerOutcomes™Page12
3. Test Result Management
PresstheResults buononthemainmenuscreentoaccessupto2,000
previouslystoredresults.YoumaysearchresultsbyIDortestdate,ordelete
allresults.
Note: When the results list reaches 2,000 tests, the analyzer deletes the oldest
test from the list. You cannot recall the deleted test.
Recall All Results
1. Ontheresultscreen,selectRecall Result toreviewallthestoredtest
  resultsarrangedinchronologicalorder.
2. Thescreenwilldisplaythemostrecenttestresult,includingthestrip
  type,testdate&me,paentIDandtestresult.
3. SelectPrinttoprintthetestresultusingtheanalyzer’sbuilt-in
  thermalprinter.
4. Ontheresultscreen,selectSend tosendthetestresulttoaPC,
  hostcomputer,orLIS,ifconguredforthisopon.
5. Ontheresultscreen,presstheoriconnexttothetestID
  toviewthepreviousornextresult.
6. Pressattheboomofthescreentoreturntotheresults
  mainmenu.
Search Results by ID
1. Ontheresultscreen,selectSearch by IDtosearchthestoredtest
  resultsbasedonIDinformaon.
2. IfyouselectPaent ID,enterthepaentIDusingthekeypadonthe
  screenandpressENTER.Allthematchingresultswillbelisted.Select
  thedesiredtestresulttoreviewonthescreen.
3. IfyouselectTest ID,enterthetestIDusingthekeypadonthescreen
  andpressENTER.Thematchingresultswillbedisplayedonthescreen.

WeSupportBeerOutcomes™
Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
Page13
Search Results by Date
1. Ontheresultscreen,selectSearch by Datetosearchthestoredtest
  resultsbasedonthetestdate.
2. EnterthedateusingthekeypadonthescreenandpressENTER.
3. Allthematchingresultswillbelisted.Selectthedesiredtestresult
  toreviewonthescreen.
Delete Results
Youmaywanttodeleteallthetestresultsunderthefollowingcircumstances:
•Acompletedownloadofallthestoredresultstoahostcomputer
  hasoccurred.
•ToprotectpaentcondenalityandcomplywithHIPAAregulaons
  whentheanalyzerismovedtoanotherclinicalsite.
•Torepairordiscardtheanalyzer.
1. Ontheresultscreen,selectDeletetodeleteallthestoredtestresults.
2. Apromptwillsay“DeleteAllResults?”Presstodeleteallresults.
3. Youcanselecttoreturntotheresultmainmenu.
Cauon:
Selecngthedeletefunconwilldeleteallthestoredtest
results.Thesystemdoesnotallowthedeleonofaspecic
testresultfordatasecurityreasons.Onceresultsaredeleted,
youcannolongerrecallthemfromthedatabase.Ifyouwanttokeepall
thedatafromyouranalyzer,pleasetransferthedatatoahostcomputer
beforeyouproceedwiththisfuncon.

Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
WeSupportBeerOutcomes™Page14
4. System Conguraon
Youcanconguretheanalyzer’ssengsandreviewthesysteminformaon
withthesengsandadvancedmenus.
4.1 Sengs
PresstheSengsbuononthemainmenuscreentoaccessthesengs
menu.Fromthismenu,youmayreviewthecurrentsengsandselectthe
typeofstriptobeused,thedisplaylanguage,date&me,enableordisable
theautomacprinngfuncon,andviewsysteminformaonfortheClarity
Planum.TheRestore Default SengandUnits Displayedoponsare
intendedforClarityDiagnoscsadministratorsonlyandrequireavalid
administratorpasswordtologin.
Strip Type
Note: The device will set by default for tesng Clarity Diagnoscs’
CLA-10P strips.
1. Onthesengsmenu,presstheStrip Typebuontoreviewthe
  currentseng.TheClarityPlanumisonlycompablewithClarity
  Diagnoscs’proprietarystrips.
2. Presstoreturntothesengsmenu.
Language
1. Onthesengsmenu,presstheLanguagebuontoreviewthe
  currentseng.TheClarityPlanumusesEnglishasthedefault
  language.TheusermaychooseSpanishfortheoperaonlanguage.
2. Selectthedesiredlanguagetochangethedisplaylanguage.
3. Presstoreturntothesengsmenu.
Date & Time
1. Reviewthedateandme,locatedonthetoprightofthescreen.
  Fromthesengsmenu,presstheDate & Timebuontoreviewthe
  currentseng.
2. Usethekeypadtoprogramthedate&meexactlyasshowninthe
  followingformat:MM/DD/YYYYHH:MMamorpm(Pleasenote:
  am/pmneedtobelowercase).PressEnter tosave.
3. Presstoreturntothesengsmenu.

WeSupportBeerOutcomes™
Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
Page15
Unit Seng
1. TheClarityPlanumurineanalyzerusesC1(convenonalunits)asthe
  defaultunitseng.
2. The Unit Seng funconisintendedforClarityDiagnoscs
  administratorsonlyandrequiresavalidadministratorpasswordtologin.
Printer Seng
1. Onthesengsscreen,pressthePrinter Sengbuontoreviewthe
  currentseng.
2. SelectAutomacorManualfortheanalyzertoprinttheresult
  automacallyormanuallyaereachtest.
3. Modifytheprinngformatbyselecngthefollowinginformaonto
  beincludedintheresultprintout:
  •OperatorID•PaentID•TestID
4. Presstoreturntothesengsmenu.
System Informaon
1. Onthesengsscreen,presstheSystem Informaonbuontoview
  theserialnumberoftheanalyzer,thecurrentClarityPlanumsoware
  versioninstalled,andtechnicalsupportcontactinformaon.
2. Presstoreturntothesengsmenu.
Restore Default Seng
1. The Restore Default SengfunconisintendedforClarityDiagnoscs
  administratorsonlyandrequiresavalidadministratorpasswordtologin.

Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
WeSupportBeerOutcomes™Page16
4.2 Advanced Sengs
PresstheAdvanced buononthemainmenuscreentoaccesstheadvanced
sengsmenu.Fromthismenu,itispossibletoperformqualitycontroltesng,
stripbedmaintenance,andsystemdiagnoscsonanalyzerhardware.
Operator
TheoperatormenuisonlyaccessibleforClarityDiagnoscsadministrators.
Test Mode
ThetestmodemenuisonlyaccessibleforClarityDiagnoscsadministrators.
Quality Control
OntheAdvancedsengsmenu,presstheQuality Control buontoaccess
thequalitycontrolmenu.Fromhere,operatorscanperformQualityControl
tesng.
TheQCsengsoponisonlyaccessibleforClarityDiagnoscsadministrators.
ThefrequencyofQCpromptsispresetto30daysor100testsbetweenQC,
whichevercomesrst.
Note: The Clarity Planum analyzer will automacally lock the test strip
funcon aer 30 days or 100 tests have been performed to ensure the
integrity of the urinalysis strips. In order to use the Clarity Planum analyzer,
CLIA Waived users are required to perform a successful QC test.
Signicance of QC tests and Consequences of Not Performing
QC Procedures
Qualitycontroltesngisaprocessofdetecngerrorswithinthetesngsiteto
ensureboththereliabilityandaccuracyoftestresultsinordertoprovidethe
bestpossiblepaentcare.Therefore,toensuretheaccuracyandperformance
oftheClarityPlanumTestSystem,qualitycontrolproceduresareincorporated
intotheClarityPlanumanalyzer.Thepurposeofincludingqualitycontrol
proceduresistoevaluatethereliabilityofthetestsystembyassayingstable
qualitycontrolmaterialthatresemblespaentsamples.

WeSupportBeerOutcomes™
Clarity Planum Urine Analyzer
OPERATOR’S MANUAL
Page17
Thequalitycontrolfunconisdesignedtodetect,reduce,andcorrect
decienciesinalaboratory’sinternalprocesspriortothereleaseofpaent
results.FailuretoconductqualitycontroltesngorcarryoutQCprocedures
couldleadtounreliableperformanceofthetestsystem,whichcouldresult
inmisdiagnosis,delayedtreatment,andincreasedcostsduetoretesng.Itis
ofgreatimportancetoensureallresultsarebothaccurateandreliable.
ClarityDiagnoscsproducesQualityControlSoluonLevelsIandII,which
areusedtoperformqualitycontroltesng.ForCLIAWaivedsengs,Clarity
Urinalysisqualitycontrolsmustbetestedunderthefollowingcondions:
• WhenanewcanisterofstripsisopenedOR
• 100testshavebeenperformedOR
• TestresultsappeartobeinaccurateOR
• AnewoperatorusestheanalyzerOR
• EachnewdayoftesngOR
• 30dayshavepassedsincethepreviousQCPassOR
• Aerperformingmaintenanceorserviceontheanalyzer.
IftheQCtestsdonotprovidetheexpectedresults,performthe
followingchecks:
• Ensurethestripsusedarenotpasttheirexpiraondate.
• Ensurethestripsarefreshfromanewcanister.
• Ensurethecontrolsarenotpasttheirexpiraondate.
• Repeatthetesttoensurenoerrorsweremadeduringthetest.
• IfQCtesngslldoesnotprovidetheexpectedresults,
  callClarityDiagnoscsTechnicalSupport:(877)485-7877,
  Monday-Friday,8am-6pmEST.
Note: For CLIA Waived sengs, only the QC controls produced by Clarity
Diagnoscs (CLA-UHCRL25) should be used, as the QC pass/fail criteria have
been opmized for the Clarity Planum analyzer.