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.