E. I. Medical Imaging Ibex EVO User manual



Ibex® EVO® Portable Ultrasound

User Guide

Published9/17/2018

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E.I.MedicalImagingUserManual391250,Rev.4



Ibex® EVO® Portable Ultrasound User Guide

E.I.MedicalImagingProprietaryandConfidential–DoNotCopyorDistribute.ForInternalUseOnly.

Theinformationpresentedinthismanualissubjecttochangewithoutnoticeanddoesnotrepresenta

commitmentonthepartofE.I.MedicalImaging.Thehardwareandsoftwaredescribedhereinarefurnished

underalicenseornondisclosureagreement.Thehardware,software,andmanualmaybeusedorcopiedonlyin

accordancewiththetermsofthisagreement.Itisagainstthelawtoreproduce,transmit,transcribe,storeina

retrievalsystem,ortranslateintoanymedium-electronic,mechanical,magnetic,optical,chemical,manual,or

otherwise-anypartofthismanualorsoftwaresuppliedwiththeIbexEVOforanypurposeotherthanthe

purchaser’spersonalusewithouttheexpresswrittenpermissionofE.I.MedicalImaging.

E.I.MedicalImaging,theE.I.MedicalImagingLogo,Ibex,EVO,Insite,andDurascanareregisteredtrademarksof

E.I.MedicalImaging.EVOStreamisatrademarkofE.I.MedicalImaging.Allotherbrandorproductnamesare

trademarksorregistrationtrademarksoftheirrespectivecompaniesororganizations.



ContactInformation:

E.I.MedicalImaging

11012THSTSWUNIT102

LOVELANDCO80537-6396

toll-free/1.866.365.6596

phone/970.669.1793

fax/970.669.1902

http://www.eimedical.com/

E-mail:info@eimedical.com



SupportingSoftwareVersion:

1.5.0.3

FCC Regulatory Information

ContainsFCCID:Z64-WL18SBMOD

ContainsIC:451I-WL18SBMOD



ThisdevicecomplieswithPart15oftheFCCRulessubject

tothefollowingtwoconditions

1)Thisdevicemustnotcauseinterference,and;

2)Thisdevicemustacceptallinterference,including

interferencethatmaycauseundesirableoperation.



WARNING:

Modification of this device without consent of the responsible party may void the users

right to operate this device.



EUCompliance



Usagerestrictionsapply.

Seedocumentation



AT BE CY CZ DK EE FI FR

DE GR HU IE IT IV LT LU

MT NL PL PT SK SI ES SE

GB IS LI NO CH BG RO TR



EU-RestrictionsforUseinthe2.4GHzBand

ThisdevicemaybeoperatedindoorsoroutdoorsinallcountriesoftheEuropean

Communityusingthe2.4GHzBand:Channels1-13exceptwherenoted.

FCC Regulatory Information



NOTE:

a)USA-FederalCommunicationsCommission(FCC)

ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice,pursuanttoPart

15ofFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainstharmfulinterferenceina

residentialinstallation.Thisequipmentgenerates,uses,andcanradiateradiofrequencyenergy.Ifnotinstalled

andusedinaccordancewiththeinstructions,itmaycauseharmfulinterferencetoradiocommunications.

However,thereisnoguaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthisequipmentdoes

causeharmfulinterferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipmentoff

andon,theuserisencouragedtotryandcorrecttheinterferencebyoneormoreofthefollowingmeasures:



lReorientorrelocatethereceivingantenna.

lIncreasethedistancebetweentheequipmentandthereceiver.

lConnecttheequipmenttooutletonacircuitdifferentfromthattowhichthereceiverisconnected.

lConsultthedealeroranexperiencedradio/TVtechnicianforhelp.



Caution:ExposuretoRadioFrequencyRadiation.

Thisdevicemustnotbeco-locatedoroperatinginconjunctionwithanyotherantennaortransmitter.



b)Canada-IndustryCanada(IC)

ThisdevicecomplieswithRSS210ofIndustryCanada.Operationissubjecttothefollowingtwoconditions:

(1)Thisdevicemaynotcauseinterference,and

(2)Thisdevicemustacceptanyinterference,includinginterferencethatmaycauseundesiredoperationofthis

device.

L'utilisationdecedispositifestautoriséeseulementauxconditionssuivantes:(1)Ilnedoitpasproduire

d'interferenceet

(2)l'utilisateurdudispositifdoitétreprêt?Acceptertouteinterferenceradioélectriquereçu,m?mesicelle-ciest

susceptibledecompromettrelefonctionnementdudispositif.

Caution:ExposuretoRadioFrequencyRadiation.

Theinstallerofthisradioequipmentmustensurethattheantennaislocatedorpointedsuchthatitdoesnotemit

RFfieldinexcessofHealthCanadalimitsforthegeneralpopulation;consultSafetyCode6,obtainablefromHealth

Canada'swebsitehttp://www.hc-sc.gc.ca/rpb.

EU

Declaration of Conformity

(Manufacturer :)

(Address):

E.I. Medical Imaging

110 12

th St SW, Unit 102

Charles Maloy

(Name)

President, E.I. Medical Imaging

(Position)

Loveland, Colorado 80537, USA

Declares that the product:

Portable Ultrasound Device for Veterinary Use: Ibex

EVO

Conforms to the following Directives:

1. Low Voltage Directive 2006/95/EC, Test Report No. EIMI-Ibex-EVO-60601-1

2.

Electromagnetic Compatibility Directive 2014/30/EU Test Report No. EI19032016IEC 04/06

3.

R&TTE Directive 1999/5/EC Test Report No. ER3N2752 TI Module WL1835MODCOM8B

4.

EMF Directive 1999/519/EC Test Report No. TBD

5. RoHS 2 Directive 2011/65/EU

Using the following primary standards:

Safety Standards (used as a guide)

EN 60601-1: 2012- Medical Electrical Equipment - Part 1: General Requirements For Basic Safety &

Essential Performance

EMC Standards:

EN 60601-1-2: 2007 : Electromagnetic Compatibility (EMC)

EN 55011: 2009 + A1:2010 : Radiated Emissions- ClassB, Group 1

EN 61000

-4-2 : Electrostatic Discharge

EN 61000

-4-3 : Radiated RF Immunity

EN 61000

-4-4 : Electrical Fast Transients/Burst

EN 61000

-4-5 : Surge Immunity

EN 61000-4-6 : Conducted RF Immunity

EN 61000-4-8 : Power Frequency H-Field Immunity

EN 61000

-4-11 : Voltage Dips, Interruptions

EN 61000

-3-2 : Power Line Harmonics and Interharmonics

EN 61000

-3-3 : Flicker

EN 300 328 v1.

8.1, TI Module Cert WL1835MODCOM8B : ERM Data Transmission in 2.4 GHz Band

EN310 489

-1 v1.9.2, TI Module Cert WL1835MODCOM8B : Common Technical Requirements (Radio)

EN310 489

-17 v2.2.1, TI Module Cert WL1835MODCOM8B

: Specific conditions Broadband Data Transmission

And complies with the relevant Essential Health and Safety Requirements.

I, undersigned, hereby declare that the equipment specified above conforms to the above Directives and Standards

and is therefore eligible to carry the CE Marking

.

Loveland, CO

(Signed at place)

June 1, 2016

(Date)

EU Declaration of Conformity No. 060116

Table of Contents

Ibex® EVO® Portable Ultrasound User Guide 1

FCC Regulatory Information 3

EU Declaration of Conformity 5

Table of Contents 6

1: Introduction 10

ProductSymbols 11

KeyFeatures 13

IntendedUses 14

EssentialPerformance 14

IntendedUse 14

2: Getting Started 15

SystemSpecifications 16

SupportedTransducersandAvailableAccessories 18

AbouttheEVOSystem 19

PhysicalInterfaces 19

BatteryCompartment 20

PoweringontheSystem 21

Transducers 22

InteractingwiththeEVO 23

Keyboard 23

SideKeyboard 26

ScreenLayout 27

On-ScreenKeyboard 29

PhysicalOperations 30

AbouttheBattery 31

ChargingtheBattery 31

ReplacingtheBattery 32

AttachingTransducers 32

WearingtheScanner 33

AbouttheVideoHeadset 33

Remote-OptionalAccessory 33

PairingtheRemotewithyourEVO 33

RemoteButtons 34

Table of Contents

RemoteBattery 34

Menus 35

TheOn-screenMenus 35

HomeMenu 35

SuperMenu 35

Movingaroundthescreens 36

UsingtheOn-BoardHelp 37

Examples 37

Training 37

3: Configuration 39

WelcomeScreen 40

SettingDayandTime 40

SettingUserPresets 41

RenamingUserPresets 42

ChangingtheDefaultUserPreset 42

ChangingtheCurrentPreset/User 42

ResettingUsers 42

AdjustingAudioSettings 43

AdjustingVideoSettings 44

AdjustingMiscOptions 45

SettingAnnotations 47

B-ModeScanOptions 48

EnablingWiFi 50

WiFiIndicators 51

Toconnecttoanetwork: 51

ToEnabletheEVOasaWirelessHUB 52

EnablingBluetooth 53

RFIDSupport 54

4: Patient Management 55

EnteringPatientIdentificationInformation 55

SearchingforaPatient 56

5: Managing Images 57

FreezingImages 58

SavingImagesandCineloops 58

SavingImages 59

UseAnnotationLabelsasFileNames 59

Table of Contents

SavingCineloops 60

RecallingImagesandCineloops 61

RecallingSavedImagesandCineloops 61

RenamingImages 62

DeletingImages 62

AnnotatingandMeasuringImages 63

AddingTextLabelstoImages 63

AddingTexttoSavedImages 63

WorkingwithDualImages 64

CarcassMerit 65

SettingupCarcassMerit 65

AnimalEntry 65

N-NewAnimalSetup 66

ReproWorkflow 67

6: Manipulating Images 69

AboutGainControls 69

UsingAutoGAIN 71

B+MModeScanning 71

AdjustingFocalZones 72

DopplerMode 73

ColorMode 73

ColorDopplerScanOptions 74

PowerMode 76

PowerDopplerScanOptions 77

ScanSettingsforPowerDoppler 77

PulseWave(PW) 79

PulseWaveScanSettings 80

7: Measuring Images 83

TakingDistanceMeasurements 83

Toassociateadistancetabletothemeasurement: 83

TakingAreaMeasurements 83

PWdoppler:PI/RIcalculation 84

8: Exporting Files 87

SavingFilestoaUSBMemoryStick 87

FileSharing 89

SettinguptheEVO 89

Table of Contents

FromyourPC 89

9: EVOStream - Sharing live Images 92

ConnectingoverWiFiDirect 93

ConfiguringiPhone®oriPad® 94

ConfiguringanAndroid™Device 94

10: Advanced System Operations 95

UpdatingSystemFirmware 95

IdentifyingSystemFirmwareVersion 95

DownloadingNewSystemFirmware 96

InstallingEVOSystemFirmware 97

ResettingyourEVO 98

ResettingtheSystem 98

RestoringaBackup 98

11: Cleaning and Maintaining the EVO 100

DisinfectantList 101

EVOSystem|Probes/Transducers|Goggles: 101

ICEExtensionHandle: 101

InSite2/InSite3HeadsetCareandMaintenance 102

LinearTransducerCareandMaintenance 102

Warranty 103

Appendix - Fetal Tables 105

1: Introduction

PleasereadalltheinstructionsandwarningsbeforeusingtheEVO®PortableUltrasoundsystem.

TheIbexEVOPortableUltrasoundUserGuideprovidesanoverviewofthefeaturesandfunctionalityoftheEVO

ultrasoundsystem.Thisguideprovidesyouwiththeinformationyouneedtoquicklysetup,operate,and

maintaintheEVO.

TheE.I.MedicalImagingIbexfamilyofultrasoundscannersareinternallybatterypoweredveterinaryuse

ultrasounddevices.AnexternalACadapterisprovidedforchargingtheinternalbatteryandpoweringtheIbex

scanners.

Thisguidedoesnotcoverthetheoryorscienceofdiagnosticsonographyorclinicalveterinarypractices.Itis

intendedforusersalreadyfamiliarwithultrasoundtechniques.

1: Introduction

Product Symbols

Thistabledescribesthesymbolsmarkedonthedevice.

Symbol Name Description

Caution



Youmustread,understand,andfollowallinstructionsin

thismanualincludingallwarnings,cautions,and

precautionsbeforeusingthemedicaldeviceinveterinary

practice.



Scanner:

Isforveterinaryuseonly.

Isnotuserserviceable.ContactE.I.MedicalImagingif

defectiveordamaged.

UseonlyspecifiedACadapter/charger.

TypeBFEquipment

TheProbe(PatientAppliedPart)isTypeBF(floatingfrom

electricalground)pertheStandardEN60601-1,whichoffers

aspecificlevelofsafety.

RoHSCompliant ThesystemiscompliantwiththeRoHS

guideline2002/95/EC

CE DevicecomplieswiththeEuropeanUnionLowVoltage

Directive(LVD)andEMCdirective.

Standby Alternatelyswitchthedevicebetweenthepower-onand

standbystates.

USB

USB2.0HostI/OPortcurrentlimited(100maperport)for

connectiontoUSBFLASHDRIVEfilestorageandsupported

peripherals.

1: Introduction

Symbol Name Description

LeadFree Allcomponents(e.g.PCBs)areleadfreeandcanbeusedin

leadfreesolderprocesses.

IngressProtection

Protectionfromdustandsplashingfromanydirection.

Protectionfromdustandlowpressurejetsofwaterfrom

anydirection.

Donotdispose Thisdeviceisnotallowedtobedisposedindomesticwaste.

ReadManual Beforeattemptingtousethisdevice,consultthemanual

and/orthequickstartguide.

1: Introduction

Key Features

TheIbexEVOisdesignedtobeflexibleandeasytouse.

Key Features

lIbexEVOadvancedimagingsoftware

lFullrangeofimagingmodes:B,B+M,PW,Color,PowerDoppler

lRuggedizedDuraScan®transducers2-14MHz

lFastboottimeformoreuptime

lCustomized,veterinary-specificexampresets

lEVOStream™WiFiRemoteScanningApp

1: Introduction

l8.4inchsealed,sunlight-readableLCDDisplay

lSealed,LEDbacklitkeyboard

l2+hourbatteryruntime(fieldswappable)

lLightweight6.1lbs(2.8kg)

lEngineeredwithDuraScan®technology

lContinuousrecord,colordoppler,pulsewavedoppler,multibeam,harmonicimaging,presetexamtypes.

Specklereduction.

lHelpsystem

Intended Uses

TheIbexEVOisintendedforveterinaryuse;Bovine,Equine,CompanionAnimal,Swine,Exotic,MarineandSmall

Ruminants

Essential Performance

Thesystemcanprovide2Dultrasoundechoandflowimagingasanaidindiagnosis,dataprocessingandguidance

ofovumpickup(OPU).

ThesystemusesanOPUguideandcollectionneedles.

Thesystemcanperformsimplegeometricmeasurementsandcalculations.

Thesystemisfreefromartifactsordistortionintheimageorerrorofadisplayedvalue,whichcanbeattributedto

aphysiologicaleffectandwhichmayalterthediagnosis.

Thesystemdisplayscorrectnumericalvaluesassociatedwiththediagnosistobeperformed.

Thesystemdoesnotgenerateunintendedorexcessiveultrasoundoutputortransducersurfacetemperature.

Intended Use

Thesystemisintendedfordiagnosticultrasoundimagingorfluidflowanalysisofanimals,dataprocessingand

guidanceofOPUandcollectionneedles.ThesystemisforVeterinaryUseOnly.

ThesystemperformssimplegeometricmeasurementsandcalculationsinVeterinaryDiagnosticImaging

ModesofOperation

lB-Mode

lM-Mode

lPWDopplerMode

lCFDopplerMode

lPowerDoppler

2: Getting Started

SystemSpecifications 16

AbouttheEVOSystem 19

InteractingwiththeEVO 23

PhysicalOperations 30

Menus 35

TheOn-screenMenus 35

Movingaroundthescreens 36

UsingtheOn-BoardHelp 37

Training 37

2: Getting Started

System Specifications

ThefollowingtableliststhesystemspecificationsfortheEVOscanner.

Applications Bovine,Equine,CompanionAnimal,Swine,Exotic,MarineandSmallRuminants

ImagingModes B,B+M,M,PW,Color,PowerDoppler

System

Dimensions

9x8.5x3inches

22.9x21.5x7.6cm

Lightweight6.1lbs(2.8kg)

Transducer

RuggedizedDuraScan®transducers2.0MHz–14.0MHz

Supportfor2.0MHzto14MHz128ElementLinear/CurvedLinearprobes

Supportforuserselectablescandirections

Connectivity USB2.0imagestorageandrecall;

Wireless(802.11)connectivityandBluetoothconnectivity

Display

8.4”diagonalLCDSVGAresolution.

21.34cm

720PHDMI,NTSC/PALanalogvideo,EVOStream

Power

Li-ionbattery2+hours

Standaloneexternalbatterychargeravailable;ACPowerAdapterforchargingor

operating;Output:15VDC4A

Scan

Measurements

Unlimitedcalipersetsfordistancemeasurements

Continuousareaofcircumference

Gridoptionforquickmeasurements

Touchpadfornavigation

Calculationtables

On-screentextannotationsandarrows

Dualimagefeatureforside-by-sidecomparisons

Tendoncalculations:%Lesion|%change|%difference.

Cardiaccalculations:FS|LA/AO

ImageStorage

480framecineloopmemory(60frames/secondframeraterecording)

AudioTagscanbestoredwithimage

Staticimagescanbesavedfromcine-loops

Measureandrecalculatefromsavedimages

Additional

Features

SystemDynamicRange156db

Auto-Optimizeimage(AutoGainandTGC)

Softwarefieldupgradable

LEDbacklitkeyboard

DuraScan®technologyforsystemdurability

2: Getting Started

StreamingVideovia802.11xusingH.264codectoiOSandAndroiddevices.

EVOStream™WiFiRemoteScanningApp

Customized,veterinary-specificexampresets

Operating

Environment

EVO:0°to40°C

InSite2/InSite3Headset:0°to40°C

Storageand

Transportation

Environment

-20°to50°C



2: Getting Started

Supported Transducers and Available Accessories

ACpowersupplyforEVOultrasound 391950

EVOultrasoundscanner 390200

BluetoothRemoteforEVO 390001

LithiumIonrechargeablesmartbatterypackforEVO 391901

Insite2headsetforultrasound 290701

i3headsetforultrasound 390700

L6EtransducerforEVO,2mcable 390400

L6EtransducerforEVO,3mcable 390405

MC8EtransducerforEVO,2mcable 390410

MC8EtransducerforEVO,3mcable 390412

L14xtransducerforEVO,3mcable 390417

MC8OPUtransducerforEVO,2mcable 390420

CL3EtransducerforEVO,3mcable 390430

L3ASEtransducerforEVO,3mcable 390450

CLI3EtransducerforEVO,3mcable 390470

C6EtransducerforEVO 390440

C9EtransducerforEVO,2mcable 390445

C90PU-HD,transducerforEVO,2mcable 390485

L7HDtransducerforEVO,2mcable 390420

L7HDtransducerforEVO,3mcable 390425



2: Getting Started

About the EVO System

TheEVOsystemcomponentsprovideprotectionagainstdustandwaterenteringtheenclosuresasdefinedinthe

IEC(InternationalElectromechanicalCommission)standards.TheEVOhasearnedaratingofIP54andisprotected

againstdustandagainstlow-pressurejetsofwatersprayedfromalldirection

TheIECstandarddefinesdegreesofprotectionexpressedas“IP”followedbytwonumbers,e.g.IP54.These

numbersrepresentthedegreeofprotection.Thefirstdigitshowsthedegreetowhichtheequipmentisprotected

againsthumancontactandsolidparticles.Theseconddigitindicatesitsdegreeofwaterprotection.

NOTE:Refertothesection,CleaningandMaintainingtheEVOonpage100,forpropercleaning

instructions.

Physical Interfaces

TheEVOhasfourinputs:

lUsethe84-pincustominterfacetoconnectthetransducers.

lUsethe8-pinmaleinterfacetoconnecteithertheheadsetortheDCpowerinput.

lTwoUSBports.USBsupportsstorageandperipherals.Thereisnochargingcapability.

lOneHDMI720p



2: Getting Started

Battery Compartment

TheEVOsystemhousesthebatteryinawater-resistantsystemaccesscompartment.

Tosealthecompartment:

1. Angletopanelinsidethemetalstrip.

2. Slidethemetallatchtowardstheleftuntilitclicksintothelockedposition.

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E. I. Medical Imaging Ibex EVO User manual

E. I. Medical Imaging Ibex EVO User manual

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