dr. maarek eis & new technology
DESCRIPTION
Electrointerstitial scanTRANSCRIPT
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LDTECHNOLOGYSYMPOSIUMCANCUN2008
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WelcometoLDTECHNOLOGY
Wearelisteningthebodysignals
<<<
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MedicaldevicesPosi.oningDiagnosis/Monitoring
• GENERALINFORMATION’S• ACCURACY
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DIAGNOSISDEFINITION*
DiagnosisistheidenEficaEon,by
processofeliminaEon,ofthenatureofanything.
*Wikipedia
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Processofelimina.oninmedicaldiagnosis
• Clinicalcontext:signs,symptoms,history,currenttreatments………………..
• SpecificExamina.ons:Medicaldevices
Imaging
InvitroLaboratorytests InvivoPhysiologicalmeasurements
.Physician’sKnowledgeandinterpreta.on
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Medicaldevices
• features:ProvideIndicatorsnecessaryfortheprocessofelimina.onfordiagnosis
• Amedicaldevicedonotmakeadiagnosis,onlyaPhysiciancanmakeadiagnosis.
• Accordingtotheinves.ga.onsite,eachmedicaldeviceisprovidingspecificindicatorsinsameordifferentdirec.on.
• Thecrossanalysisofallindicatorsarenecessaryintheprocessofelimina.onfordiagnosisandinterpreta.onandknowledgeofthephysician
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AccuracyoftheMedicaldevices
DependoftheSpecificityandSensi.vityoftheIndicatorsprovided.
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Specificityandsensi.vity
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Diagnosisarehypothesis
• AWertheprocessofelimina.on,thecrossanalysisoftheclinicalcontextandsupplementaryexamina.ons,thephysicianmakeahypothesisofdiagnosis:becausethehumanbodyisacomplexofbalanceandallthedysfunc.onsordiseaseshaveimplica.onsinallthebodysystems
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TreatmentchoiceHypothesisofdiagnos.c
AdaptedTreatmentofthediagnoseddiseasesissuesfromtheclinicalinves.ga.ons
Improvementoftheclinicalcontext
Improvementoftheresultsofthesupplementaryexamina.ons
NoImprovementoftheresultsofthesupplementaryexamina.ons
OrImprovementornoimprovementofthe
clinicalcontext
MONITORING
Valida.onofthediagnosishypothesis
Novalida.on,misdiagnosisorno
responsesduestointerindividualdifference
Sideeffectoverthebenefitsofthetreatment
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EISSYSTEMTECHNOLOGY
• FEATURES• BACKGROUND
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EISMeasurement
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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.
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EISFeatures
Sequenceofthemeasurementofthe22bodysegments
ESGgraphic:conduc.vityofthe22segments
ESGnormalrangevalues
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EISFeatures(2)
Venndiagramcalcula.on
Maxwellequa.on’scalcula.onModeling
CONDUCTIVITY
Min
Max
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Thecurrentiscarrierbytheions.TheCurrentissendingfromtheAnode(+)toCathode(‐),andthereforetheNa+(mostsignificantconcentraEonofposiEveionsintheIF)aremovingtothenegaEvepole.
TheconducEvityisproporEonallyincreasedwiththeNa+concentraEonandthevolumeoftheintersEEalfluid
1.28V
EIS/EFFECTOFTHEDCCURRENTININTERSTITIALFLUID
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Na+/K+pumpNa+/H+an.porterNa+/ATPProduc.on
Na+
Na+Na+
Na+Na+
Na+Na+ Na+ Na+H+
ATP
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IntersEEalfluidvolumeandOxygendelivery
EffectofintercapillarydistanceonrelaEonbetweenoxygendeliveryBMJ.1998November14;317(7169):1370–1373.
Copyright©1998,BriEshMedicalJournal
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EISMODELINGPARAMETERS
• I.SFvolume
RelatedwiththeOxygendeliveryandosmo.c/hydrosta.cpressure
• I.SF[Na+]Relatedwith[K+](2/3),[H+]andATPproduc.on.
• BloodflowRelatedwiththeBloodviscosityandtheBloodvelocity.
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EIS–BFSYSTEM
• CLINICALINVESTIGATIONS
• UPDATEVERSION10
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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%
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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).
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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,).
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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,).
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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,).
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ADHDChildrenProfile
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EISBFResultsVersion10
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Diges.vesystemIndicators
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BrainIndicators
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CardiovascularIndicators
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HORMONALINDICATORS
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RESPIRATORYINDICATORS
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Generalmetabolicindicators
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Urogenitalandrenalindicators
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Followupofalltheindicators
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Medica.onsmonitoringindicators
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An.depressant(SSRI)Followup
Beforetreatment Response
Noresponse
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FollowupoftheCerebralneurotransmirers
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Medica.onsmonitoringindicators
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Followupofthyroidtreatment
Beforetreatment Monitoringandresults
Overdoses Underdoses
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Medica.onsmonitoringindicators
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An.agregantsandan.coagulantsfollowup
Beforetreatment Effec.vetreatment
Noeffec.ve
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Medica.onsmonitoringindicators
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Betablockersfollowup
Beforetreatment Noeffec.vetreatment
Overdosisandsideeffects Goodtreatment
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CEIFollowup
Beforetreatment Goodtreatment
Overdoseandsideeffect Noeffec.ve
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ADHDChildrenprofileanddiagnosisinadjunctwiththeclinicalcontext
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IndicatorofADHDChildren
LackDopamineandSerotoninandsignsandsymptomsfromclinicalcontextchildrenless17y.o
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EISPOSITIONING
• QUALITYSYSTEMINMEDECINE
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EISSystem:Maybeapossibilityforhelpthequalitysystemrequirementsinmedicine
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Posi.oningoftheEISintheQualitySystemRequirements
Riskmanagement/
PaEent'compliance Pa.ent'needs
Consulta.on
Supplementaryexamina.ons
Diagnos.csTreatments
Control
Correc.veac.ons
Control
EISSYSTEM
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WhyaqualitysystemwiththeEISSystem
• Noinvasive,quick,usability,Lowcost• Forthepa.ent:Understandingofthetreatmentandgoalofthetreatment
• Fortheprac..onerEarlyvisualiza.onofthetherapiesandearlypossibilityofcorrec.veac.on
• Becauseadiseasetreatmentrequiresdrug,some.mesurgeryandalwayslifestylechange
• Because,themajordiseasescannotbetreatedbylifestylechangeoralterna.vemedicine.
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Benefitsofthequalitysysteminmedicine
• Forthepa.ent:Visualiza.on/mo.va.on/compliance• Fortheprac..oner: Organiza.on,save.me Bererunderstandingoftheintendeduseandsideeffectsofthetreatmentsused
Correc.veac.onsthatthepa.entcanunderstand Referrals Incomeincreased
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NEWPRODUCTS
• WHY?
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Newproducts
• EIS• BWS:Wellnessandlifestyle
• ESTeck:Es.matedoftheANSac.vityandofcardiovascularindicators.510kinprogress
NrK083229
• ESTeckComplex:Combina.onEIS/ESTeck
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EISNewapplica.on:BSW(BodyScanWellness)
• WhyBSW?Because
Thereisnotgoodorbaddietforeverypeople,thereisgoodorbaddietforeachperson
Thechangeofnutri.onneedtobemonitoringandthegoodnutri.onforeachpersonisnotavailableallhislife.
BasedontheEISandBCdevicemeasurement
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WhytheESTeck
• BecauseHRV(ANSac.vityes.ma.on)
PhotoelectricalPlethysmograph(Vasculares.ma.on)
bodycomposi.onandthephaseAnglemeasurement
Cangivenewindicatorsintheprocessofelimina.onofthephysician’sdiagnosis
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WhytheESTeckComplex
Combina.onoftheEISandtheESTeck:Because:
Thecrossanalysisoftheindicatorsissuefrom4differenttechnologieswillincreasethesensi.vityandthereforetheaccuracyofamedicaldevice
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BODYSCANWELLNESS
• Newapplica.onoftheEISTechnology
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BWSMeasurement
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BSWResults
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BodyComposi.on
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NutriEonalandmicronutrionalprogramAnalysis
Bodycomposi.on
BMI
AcidbaseConduc.vity
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Nutri3onalAnalysisReport
Allresultsshouldbeconsideredintheclinicalcontextofthepa3ent'scasehistory,symptoms,knowndiagnosis,currentmedica3ons,treatmentplanandtherapies.Thisdietanalysisdoesnotreplacetheadviceofyourprac33oner.
Thees3matedbodycomposi3onismadeaccordingtotheJamesequa3onandtheformulasfromthepeerreviews.
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Nutri.onalAnalysisReport(2)
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BodyComposi.onFollowup
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ESTECKSYSTEM
• GENERALINFORMATION’S
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ESTeckSystem(Cardiology)
• HRVPhotoelectricalPlethysmograph
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HRV(short.me)
HRVReference:
TaskForceofTheEuropeanSocietyofCardiologyandTheNorthAmericanSocietyofPacingandElectrophysiology(1996)
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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
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ESTeckMeasurements
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HeartRateandsinusnodedepolarizaEon
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AutonomicNervousSystemandHeartratevariability
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SpO2ANDPhotoelectricalPlethysmography
SpO2Probe
Infrared/Red 660/905nm
Photodiode
SpO2%
PR
Vascularwaves
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SpO2ANALYSIS
Oxygen‐hemoglobinAffinityChanges.
Thefunc.onsofhemoglobinareoxygenpickupanddelivery.Thehemoglobinhasanaffinity(thestrengthofbondbetweenoxygenandhemoglobin)thatcanbeincreasedordecreasedduetovarioussitua.ons.Ifhemoglobinhasanincreasedaffinity,itishighlysaturated;butoxygenislessavailableforreleasetothe.ssuesduetothestrongbond.Thereverseisalsotrue.
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VascularWaveAnalysis
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AnalysisbyAccelera.onandSecondderiva.ve
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AnalysisoftheSecondderiva.vewithage
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Analysisofthesecondderiva.veanddiseases:b/a
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Analysisofthesecondderiva.veanddiseases:d/a
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Specificityandsensi.vityoftheb/aandd/aindicators
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Specificityandsensi.vityoftheb/aandd/aindicators
Ref.ToshiakiOTSUKA,TomoyukiKAWADA,MasaoKATSUMATA,ChikaoIBUKI,andYoshikiKUSAMAIndependentDeterminantsofSecondDeriva.veoftheFingerPhotoplethysmogramamongVariousCardiovascularRiskFactorsinMiddle‐AgedMenHypertensResVol.30,No.12(2007)
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ResultsofESTeck
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HRVSTATISTICALRESULTS
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SpO2andPhotoelectricalPlethysmographresults
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E.STECKCOMPLEX
• GENERALINFORMATION’S
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ESTECKCOMPLEXTHENATURALEISUPDATE
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ESTeckComplexMeasurements
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CROSSANALYSIS
Cross
Analysis
EIS
HRV
SpO2/PP
BIA
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• HRVmodule:ToanalyzethebasicrhythmsoftheNNorRRintervalsinelectrocardiograms,bothinthe.medomainandinthefrequencydomain(short.me5minutes)
• Itonlyprovidesnumericalanalysesoftheinputelectrocardiogram.• EsEmateoftheparasympatheEcandsympatheEcsystem
sEmulaEon.• PPmodule:Analyzethepulsewaveformbyphotoelectric
plethysmographyandPulserate.• EvaluaEonofLargeandsmallartery
• EISmodule:• Monitoringofdiseases,funcEonalandlifestyle‘treatments
• AdjuncttoconvenEonaldiagnosisofADHDchildren• BIAmodule:• CalculaEonandHistoricalTrackingofbodycomposiEon
E.STECKCOMPLEXINTENDEDUSES
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BodyImpedanceAnalysis(BIA)MeasurementoftheResistanceandReactanceinTetrapolarmodewithafrequencyof50
KHz
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ResistanceandReactancemeasurements
• Resistanceisameasureofhowdifficultitisforelectricitytoflowthroughanobject.
• ReactanceMostobjectshavesomecapacitance,whichisameasureofabilitytostoreanelectricalcharge.Themorecapacitancetheobjecthas,orthefasterthecurrentchangesdirec.on,thelesstheobjectwill“react”tothecurrent.
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EISBIA
Peerreviewsformula• TotalBodyWater:TWB5‐19y.oDaviesetal198820‐80y.oLukaskiandBolonchuk1988Adultobesesubjects:Segaletal1988• Fatfreefatmass:7‐15y.oDeurenbergetal199116‐83y.oDeurenbergetal1991• Extracellularwatervolume:EWCSergiG,etal1994
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PhaseAngle
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ImpedanceComponents
Phase Angle
Xc = 1 / (2 * PI * F * C), C – Capacity [Farad]
Phase Angle = Arctan (Xc / R)
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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).
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Impactofphaseangleinlivercirrhosis
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NEWINTERFACE
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E.STECKRESULTS
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EISANALYSIS
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HRVSTATISTICALRESULTS
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HRVRECORDS
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HRVGEOMETRICALANALYSIS
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SpO2RESULTSANDMANAGEMENTOFTHEPHOTOELECTRICALWAVE
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PHOTOELECTRICALPLETHYSMOGRAPHANALYSISANDRESULTS
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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
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BODYCOMPOSITIONRESULTS
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BodyComposi.onfollowup
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E.STECKCOMPLEX
• CROSSANALYSIS• MODELINGANDBODYSYSTEMS’INDICATORS
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DIGESTIVESYSTEMINDICATORS
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BRAININDICATORS
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CARDIOVASCULARINDICATORS
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HORMONALINDICATORS
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RESPIRATORYSYSTEMINDICATORS
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GENERALMETABOLICINDICATORS
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UROGENITALANDRENALINDICATORS
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Followupofalltheindicators
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FollowupoftheCerebralneurotransmirers
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Medica.onsmonitoringindicators
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Medica.onsmonitoringindicators
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Medica.onsmonitoringindicators
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Medica.onsmonitoringindicators
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ADHDChildrenprofileanddiagnosisinadjunctwiththeclinicalcontext
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ChiropractorIndicatorsandmonitoringtreatment
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AdvicesforLifestyleandexercisesandmonitoring
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AdvicesforLifestyleandexercisesandmonitoring
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AdvicesforLifestyleandexercisesandmonitoring
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Exercises
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Sportmencondi.onEvalua.onandimprovement
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Sta.s.calriskanalysis
• Noaccessbefore5measurements.Theaccuracyincreasedwiththenumberofmeasurements.
• Sta.s.calanalysisoftheindicatorsofeachbodysystemsandmetabolicgeneralindicators
• Itisnotadiagnosis,buthelpforthephysicianintheprocessofelimina.on
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TECHNICALSUPPORT
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RemoteTechnicalSupportAssistance
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RemoteTechnicalSupportAssistance
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Installa.onproblems
N DescripEonormessage SoluEon
1 Windowscan’tfindUSBdeviceDriver
ReadUser’smanualandinstalldriver’saccordingtoinstruc.onstepbystep,CallTechnicalSupportAssistance
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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
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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
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ContractofMaintenanceFreethefirstyear
AndthenUS$500/YearIfnomaintenancecontract:
Updateprice:US$400Eachtechnicalsupportinterven.on:US$80