LDTECHNOLOGYSYMPOSIUMCANCUN2008

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MedicaldevicesPosi.oningDiagnosis/Monitoring

•  GENERALINFORMATION’S•  ACCURACY

DIAGNOSISDEFINITION*

DiagnosisistheidenEficaEon,by

processofeliminaEon,ofthenatureofanything.

*Wikipedia

Processofelimina.oninmedicaldiagnosis

•  Clinicalcontext:signs,symptoms,history,currenttreatments………………..

•  SpecificExamina.ons:Medicaldevices

 Imaging

 InvitroLaboratorytests InvivoPhysiologicalmeasurements

.Physician’sKnowledgeandinterpreta.on

Medicaldevices

•  features:ProvideIndicatorsnecessaryfortheprocessofelimina.onfordiagnosis

•  Amedicaldevicedonotmakeadiagnosis,onlyaPhysiciancanmakeadiagnosis.

•  Accordingtotheinves.ga.onsite,eachmedicaldeviceisprovidingspecificindicatorsinsameordifferentdirec.on.

•  Thecrossanalysisofallindicatorsarenecessaryintheprocessofelimina.onfordiagnosisandinterpreta.onandknowledgeofthephysician

AccuracyoftheMedicaldevices

DependoftheSpecificityandSensi.vityoftheIndicatorsprovided.

Specificityandsensi.vity

Diagnosisarehypothesis

•  AWertheprocessofelimina.on,thecrossanalysisoftheclinicalcontextandsupplementaryexamina.ons,thephysicianmakeahypothesisofdiagnosis:becausethehumanbodyisacomplexofbalanceandallthedysfunc.onsordiseaseshaveimplica.onsinallthebodysystems

TreatmentchoiceHypothesisofdiagnos.c

AdaptedTreatmentofthediagnoseddiseasesissuesfromtheclinicalinves.ga.ons

Improvementoftheclinicalcontext

Improvementoftheresultsofthesupplementaryexamina.ons

NoImprovementoftheresultsofthesupplementaryexamina.ons

OrImprovementornoimprovementofthe

clinicalcontext

MONITORING

Valida.onofthediagnosishypothesis

Novalida.on,misdiagnosisorno

responsesduestointerindividualdifference

Sideeffectoverthebenefitsofthetreatment

EISSYSTEMTECHNOLOGY

•  FEATURES•  BACKGROUND

EISMeasurement

EISSYSTEMFeatures:Impedanceplethysmography

1.Measurementoftheconduc.vityinDC*of22segmentsofthehumanbody.

*Theconduc.vityinDC(wayfromanode(+)tocathode(‐))ispropor.onalwiththe:

  I.S.Fvolume  I.S.FIonicconcentra.onandinpar.culartheNa+concentra.on  BloodflowConduc.vitymeasurementaccuracy+/‐3.5%2.Modeling**oftheHumanbodyaccordingtotheconduc.vityofthe

22segmentsbymathema.calapplica.onoftheVenndiagramandthenormalposi.oningextrapola.onofthebodysystems.

**Accuracyofthemodeling(p<0.001)forthecerebralfrontallobes,diges.vesystemProstateandthyroid.

EISFeatures

Sequenceofthemeasurementofthe22bodysegments

ESGgraphic:conduc.vityofthe22segments

ESGnormalrangevalues

EISFeatures(2)

Venndiagramcalcula.on

Maxwellequa.on’scalcula.onModeling

CONDUCTIVITY

Min

Max

Thecurrentiscarrierbytheions.TheCurrentissendingfromtheAnode(+)toCathode(‐),andthereforetheNa+(mostsignificantconcentraEonofposiEveionsintheIF)aremovingtothenegaEvepole.

TheconducEvityisproporEonallyincreasedwiththeNa+concentraEonandthevolumeoftheintersEEalfluid

1.28V

EIS/EFFECTOFTHEDCCURRENTININTERSTITIALFLUID

Na+/K+pumpNa+/H+an.porterNa+/ATPProduc.on

Na+

Na+Na+

Na+Na+

Na+Na+ Na+ Na+H+

ATP

IntersEEalfluidvolumeandOxygendelivery

EffectofintercapillarydistanceonrelaEonbetweenoxygendeliveryBMJ.1998November14;317(7169):1370–1373.

Copyright©1998,BriEshMedicalJournal

EISMODELINGPARAMETERS

•  I.SFvolume

RelatedwiththeOxygendeliveryandosmo.c/hydrosta.cpressure

•  I.SF[Na+]Relatedwith[K+](2/3),[H+]andATPproduc.on.

•  BloodflowRelatedwiththeBloodviscosityandtheBloodvelocity.

EIS–BFSYSTEM

• CLINICALINVESTIGATIONS

• UPDATEVERSION10

EIS‐BFClinicalInves.ga.ons

AccuracyforMonitoringofthefollowingtreatment(p<0.001):Sp94%Nosensi.vity

•  Thyroidsubs.tutetreatment

•  Hypotensors(BetablockersandCEI)•  An.coagulants•  An.depressantsSSRIAccuracyinAdjunctinconven.onaldiagnosisoftheADHDchildren:(p<0.0001):

Sp95%/Se78%

Visit1:NotreatmentVisit2:Dosage100µgVisit3:Dosage120µgVisit4:Dosage150µgVisit5:Dosage100µg

Visit1:‐40Visit2:‐10Visit3:0Visit4:+20Visit5:‐5

Visit1Visit2:6Visit3:3Visit4:0Visit5:2

ThyroidvalueinEISModeling

TSHmeasuredinlabtests

N=52(r=0.79,P<0.001,

andr=0.80,P<0.001,respec.vely).

N=52(r=0.81,P<0.001,

andr=0.73,P<0.001,respec.vely).

N=52(r=0.79,P<0.001,andr=0.80,P<0.001,).

N=52(r=0.79,P<0.001,andr=0.80,P<0.001,).

N=52

(r=0.79,P<0.001,andr=0.80,P<0.001,).

N=52

(r=0.79,P<0.001,andr=0.80,P<0.001,).

N=52

(r=0.79,P<0.001,andr=0.80,P<0.001,).

N=52

(r=0.79,P<0.001,andr=0.80,P<0.001,).

ADHDChildrenProfile

EISBFResultsVersion10

Diges.vesystemIndicators

BrainIndicators

CardiovascularIndicators

HORMONALINDICATORS

RESPIRATORYINDICATORS

Generalmetabolicindicators

Urogenitalandrenalindicators

Followupofalltheindicators

Medica.onsmonitoringindicators

An.depressant(SSRI)Followup

Beforetreatment Response

Noresponse

FollowupoftheCerebralneurotransmirers

Medica.onsmonitoringindicators

Followupofthyroidtreatment

Beforetreatment Monitoringandresults

Overdoses Underdoses

Medica.onsmonitoringindicators

An.agregantsandan.coagulantsfollowup

Beforetreatment Effec.vetreatment

Noeffec.ve

Medica.onsmonitoringindicators

Betablockersfollowup

Beforetreatment Noeffec.vetreatment

Overdosisandsideeffects Goodtreatment

CEIFollowup

Beforetreatment Goodtreatment

Overdoseandsideeffect Noeffec.ve

ADHDChildrenprofileanddiagnosisinadjunctwiththeclinicalcontext

IndicatorofADHDChildren

LackDopamineandSerotoninandsignsandsymptomsfromclinicalcontextchildrenless17y.o

EISPOSITIONING

•  QUALITYSYSTEMINMEDECINE

EISSystem:Maybeapossibilityforhelpthequalitysystemrequirementsinmedicine

Posi.oningoftheEISintheQualitySystemRequirements

Riskmanagement/

PaEent'compliance Pa.ent'needs

Consulta.on

Supplementaryexamina.ons

Diagnos.csTreatments

Control

Correc.veac.ons

Control

EISSYSTEM

WhyaqualitysystemwiththeEISSystem

•  Noinvasive,quick,usability,Lowcost•  Forthepa.ent:Understandingofthetreatmentandgoalofthetreatment

•  Fortheprac..onerEarlyvisualiza.onofthetherapiesandearlypossibilityofcorrec.veac.on

•  Becauseadiseasetreatmentrequiresdrug,some.mesurgeryandalwayslifestylechange

•  Because,themajordiseasescannotbetreatedbylifestylechangeoralterna.vemedicine.

Benefitsofthequalitysysteminmedicine

•  Forthepa.ent:Visualiza.on/mo.va.on/compliance•  Fortheprac..oner: Organiza.on,save.me Bererunderstandingoftheintendeduseandsideeffectsofthetreatmentsused

 Correc.veac.onsthatthepa.entcanunderstand Referrals Incomeincreased

NEWPRODUCTS

•  WHY?

Newproducts

•  EIS•  BWS:Wellnessandlifestyle

•  ESTeck:Es.matedoftheANSac.vityandofcardiovascularindicators.510kinprogress

NrK083229

•  ESTeckComplex:Combina.onEIS/ESTeck

EISNewapplica.on:BSW(BodyScanWellness)

•  WhyBSW?Because

Thereisnotgoodorbaddietforeverypeople,thereisgoodorbaddietforeachperson

Thechangeofnutri.onneedtobemonitoringandthegoodnutri.onforeachpersonisnotavailableallhislife.

BasedontheEISandBCdevicemeasurement

WhytheESTeck

•  BecauseHRV(ANSac.vityes.ma.on)

PhotoelectricalPlethysmograph(Vasculares.ma.on)

bodycomposi.onandthephaseAnglemeasurement

Cangivenewindicatorsintheprocessofelimina.onofthephysician’sdiagnosis

WhytheESTeckComplex

Combina.onoftheEISandtheESTeck:Because:

Thecrossanalysisoftheindicatorsissuefrom4differenttechnologieswillincreasethesensi.vityandthereforetheaccuracyofamedicaldevice

BODYSCANWELLNESS

•  Newapplica.onoftheEISTechnology

BWSMeasurement

BSWResults

BodyComposi.on

NutriEonalandmicronutrionalprogramAnalysis

Bodycomposi.on

BMI

AcidbaseConduc.vity

Nutri3onalAnalysisReport

Allresultsshouldbeconsideredintheclinicalcontextofthepa3ent'scasehistory,symptoms,knowndiagnosis,currentmedica3ons,treatmentplanandtherapies.Thisdietanalysisdoesnotreplacetheadviceofyourprac33oner.

Thees3matedbodycomposi3onismadeaccordingtotheJamesequa3onandtheformulasfromthepeerreviews.

Nutri.onalAnalysisReport(2)

BodyComposi.onFollowup

ESTECKSYSTEM

•  GENERALINFORMATION’S

ESTeckSystem(Cardiology)

•  HRVPhotoelectricalPlethysmograph

HRV(short.me)

HRVReference:

TaskForceofTheEuropeanSocietyofCardiologyandTheNorthAmericanSocietyofPacingandElectrophysiology(1996)

SpO2andPhotoelectricalPlethysmograph

References:•  NicholsWW,O’RourkeMF.McDonald’s:BloodFlowinArteries:Theore.cal,

ExperimentalandClinicalPrinciples.London:Arnold,1998.•  Takazawa,Kenji;Tanaka,Nobuhiro;Fujita,Masami;Matsuoka,Osamu;Saiki,

Tokuyu;Aikawa,Masaru;Tamura,Sinobu;Ibukiyama,Chiharu:AssessmentofVasoac.veAgentsandVascularAgingbytheSecondDeriva.veofPhotoplethysmogramWaveformHypertension:Volume32(2)August1998pp365‐370

•  IToshiakiOTSUKA,TomoyukiKAWADA,MasaoKATSUMATA,ChikaoIBUKI,andYoshikiKUSAMAndependentDeterminantsofSecondDeriva.veoftheFingerPhotoplethysmogramamongVariousCardiovascularRiskFactorsinMiddle‐AgedMenHypertensResVol.30,No.12(2007)

•  ToshiakiOtsuka,,TomoyukiKawada,MasaoKatsumata,ChikaoIbuki,:U.lityofSecondDeriva.veoftheFingerPhotoplethysmogramfortheEs.ma.onoftheRiskofCoronaryHeartDiseaseintheGeneralPopula.onCircJ2006;70:304–310

•  AlbertoAvolio:Thefingervolumepulseandassessmentofarterialproper.es.JournalofHypertension2002,20:2341–2343

•  OximeterGuidelines1998

ESTeckMeasurements

HeartRateandsinusnodedepolarizaEon

AutonomicNervousSystemandHeartratevariability

SpO2ANDPhotoelectricalPlethysmography

SpO2Probe

Infrared/Red 660/905nm

Photodiode

SpO2%

PR

Vascularwaves

SpO2ANALYSIS

Oxygen‐hemoglobinAffinityChanges.

Thefunc.onsofhemoglobinareoxygenpickupanddelivery.Thehemoglobinhasanaffinity(thestrengthofbondbetweenoxygenandhemoglobin)thatcanbeincreasedordecreasedduetovarioussitua.ons.Ifhemoglobinhasanincreasedaffinity,itishighlysaturated;butoxygenislessavailableforreleasetothe.ssuesduetothestrongbond.Thereverseisalsotrue.

VascularWaveAnalysis

AnalysisbyAccelera.onandSecondderiva.ve

AnalysisoftheSecondderiva.vewithage

Analysisofthesecondderiva.veanddiseases:b/a

Analysisofthesecondderiva.veanddiseases:d/a

Specificityandsensi.vityoftheb/aandd/aindicators

Specificityandsensi.vityoftheb/aandd/aindicators

Ref.ToshiakiOTSUKA,TomoyukiKAWADA,MasaoKATSUMATA,ChikaoIBUKI,andYoshikiKUSAMAIndependentDeterminantsofSecondDeriva.veoftheFingerPhotoplethysmogramamongVariousCardiovascularRiskFactorsinMiddle‐AgedMenHypertensResVol.30,No.12(2007)

ResultsofESTeck

HRVSTATISTICALRESULTS

SpO2andPhotoelectricalPlethysmographresults

E.STECKCOMPLEX

•  GENERALINFORMATION’S

ESTECKCOMPLEXTHENATURALEISUPDATE

ESTeckComplexMeasurements

CROSSANALYSIS

Cross

Analysis

EIS

HRV

SpO2/PP

BIA

•  HRVmodule:ToanalyzethebasicrhythmsoftheNNorRRintervalsinelectrocardiograms,bothinthe.medomainandinthefrequencydomain(short.me5minutes)

•  Itonlyprovidesnumericalanalysesoftheinputelectrocardiogram.•  EsEmateoftheparasympatheEcandsympatheEcsystem

sEmulaEon.•  PPmodule:Analyzethepulsewaveformbyphotoelectric

plethysmographyandPulserate.•  EvaluaEonofLargeandsmallartery

•  EISmodule:•  Monitoringofdiseases,funcEonalandlifestyle‘treatments

•  AdjuncttoconvenEonaldiagnosisofADHDchildren•  BIAmodule:•  CalculaEonandHistoricalTrackingofbodycomposiEon

E.STECKCOMPLEXINTENDEDUSES

BodyImpedanceAnalysis(BIA)MeasurementoftheResistanceandReactanceinTetrapolarmodewithafrequencyof50

KHz

ResistanceandReactancemeasurements

•  Resistanceisameasureofhowdifficultitisforelectricitytoflowthroughanobject.

•  ReactanceMostobjectshavesomecapacitance,whichisameasureofabilitytostoreanelectricalcharge.Themorecapacitancetheobjecthas,orthefasterthecurrentchangesdirec.on,thelesstheobjectwill“react”tothecurrent.

EISBIA

Peerreviewsformula•  TotalBodyWater:TWB5‐19y.oDaviesetal198820‐80y.oLukaskiandBolonchuk1988Adultobesesubjects:Segaletal1988•  Fatfreefatmass:7‐15y.oDeurenbergetal199116‐83y.oDeurenbergetal1991•  Extracellularwatervolume:EWCSergiG,etal1994

PhaseAngle

ImpedanceComponents

Phase Angle

Xc = 1 / (2 * PI * F * C), C – Capacity [Farad]

Phase Angle = Arctan (Xc / R)

Clinicalapplica.oninsurvivalincolorectalcancer

Thesurvivalcurvesforthe2categoriesofphaseangleareshown.Pa.entswithaphaseangle<5.57

hadamediansurvivalof8.6mo(95%CI:4.8,12.4;n=26),andthosewith

aphaseangle>5.57hadamediansurvivalof40.4mo(95%CI:21.9,58.8;n=26);thisdifferencewas

significant(P=0.0001).

Impactofphaseangleinlivercirrhosis

NEWINTERFACE

E.STECKRESULTS

EISANALYSIS

HRVSTATISTICALRESULTS

HRVRECORDS

HRVGEOMETRICALANALYSIS

SpO2RESULTSANDMANAGEMENTOFTHEPHOTOELECTRICALWAVE

PHOTOELECTRICALPLETHYSMOGRAPHANALYSISANDRESULTS

VascularIndicators

•  PH:Rela.onwithbloodflowofsmallartery•  EEI:Rela.onwithLVejec.onandelas.cityoflargeartery‐LVEjec.onInsufficiency

•  DDI:Rela.onwithcontrac.onandtensionofsmallartery‐Hypertension&Arteriosclerosis

•  DEI:Rela.onwithbloodflowtoveinsystem.

•  Etc(Es.matedCardiacEjec.on.me):260~380Func.onofleWventricle

BODYCOMPOSITIONRESULTS

BodyComposi.onfollowup

E.STECKCOMPLEX

•  CROSSANALYSIS•  MODELINGANDBODYSYSTEMS’INDICATORS

DIGESTIVESYSTEMINDICATORS

BRAININDICATORS

CARDIOVASCULARINDICATORS

HORMONALINDICATORS

RESPIRATORYSYSTEMINDICATORS

GENERALMETABOLICINDICATORS

UROGENITALANDRENALINDICATORS

Followupofalltheindicators

FollowupoftheCerebralneurotransmirers

Medica.onsmonitoringindicators

Medica.onsmonitoringindicators

Medica.onsmonitoringindicators

Medica.onsmonitoringindicators

ADHDChildrenprofileanddiagnosisinadjunctwiththeclinicalcontext

ChiropractorIndicatorsandmonitoringtreatment

AdvicesforLifestyleandexercisesandmonitoring

AdvicesforLifestyleandexercisesandmonitoring

AdvicesforLifestyleandexercisesandmonitoring

Exercises

Sportmencondi.onEvalua.onandimprovement

Sta.s.calriskanalysis

•  Noaccessbefore5measurements.Theaccuracyincreasedwiththenumberofmeasurements.

•  Sta.s.calanalysisoftheindicatorsofeachbodysystemsandmetabolicgeneralindicators

•  Itisnotadiagnosis,buthelpforthephysicianintheprocessofelimina.on

TECHNICALSUPPORT

RemoteTechnicalSupportAssistance

RemoteTechnicalSupportAssistance

Installa.onproblems

N DescripEonormessage SoluEon

1 Windowscan’tfindUSBdeviceDriver

ReadUser’smanualandinstalldriver’saccordingtoinstruc.onstepbystep,CallTechnicalSupportAssistance

SoWwareproblems

N DescripEonormessage SoluEon1 GDIError ReinstallEISsoWware2 VisualC++Run.meerror…on

3DimageInstallnewGraphicDriver

3 VersionOpenGLlessthen1.2 InstallnewGraphicDriver4 EISSoWwareworksveryslowly Switchcomputer’sPower

Op.ontoHighPerformance5 LoginorPasswordisincorrect CallTechnicalSupport

Assistance6 SoWwarerequiresanewPIN

codeCallTechnicalSupportAssistance

7 RightorLeWElectrodeisnotconnectedduringscanprocess..

SeeHardwareProblems

HardwareproblemsN DescripEonormessage SoluEon1 Deviceisdisconnected… CheckDriver’sinstalla.oninDevice

Manager,ReconnectUSBcable,restartthecomputer

2 ChannelsTestorPowerTestisnotOK 1.Disconnectthecablesforelectrodesfromdevice,makethetestagain

3 ChannelsTestorPowerTestisnotOK 2.CheckthedeviceisconnecteddirectlytoUSBportandtherearenotanyUSBHUBs

4 ChannelsTestorPowerTestisnotOK 3.CallTechnicalSupportAssistance5 RightorLeWElectrodeisdisconnectedduring

scanandsomevolumesareverylow(‐100)1.Checkandremovefilmprotec.onfromelectrode’ssurface

6 RightorLeWElectrodeisdisconnectedduringscanandsomevolumesareverylow(‐100)

2.Makecable’stest,Connec.onWizardTest,Disconnectallcablesandconnectagain

7 RightorLeWElectrodeisdisconnectedduringscanandsomevolumesareverylow(‐100)

3.CallTechnicalSupportAssistance

ContractofMaintenanceFreethefirstyear

AndthenUS$500/YearIfnomaintenancecontract:

Updateprice:US$400Eachtechnicalsupportinterven.on:US$80