LELTEK Leltek Ultrasound Imaging System (MODEL:LU700 Series) L K _U I-L U 700-01 USER MAUNAL REV. 0.
Disclaimer T hisdisclaim erextendstoallprintedm atteraccom panying theL eltekU ltrasoundIm aging S ystem . T hism anualislicensed underthe L elteksoftw are and m aintenance agreem ent.You m ay not use thism anualexcept in com pliance w ith the license.T he inform ation contained in these m aterialsisproprietary and confidentialto L eltekInc.(“ L eltek“ )and isprovided forthe sole use oftheindividualorentity to w hom itisaddress ed and therefore thesem aterialsm ust be kept in the strictest confidence.
Revision History Revision U s erM anual(L K_U I-LU 700-01)R evision0.
Contents Chapter 1 About Leltek Ultrasound Imaging System..................................................4 About This User Manual .............................................................................4 About Leltek Ultrasound Imaging System.................................................5 Ultrasound Gels ..........................................................................................7 LU700 Ultrasound Imaging System Description .......................................
Chapter 4 Device Maintenance .................................................................................37 Turning the Device ON and OFF ..............................................................37 Transducer Care........................................................................................37 Cleaning & Disinfecting ............................................................................38 Chapter 5 Regarding Diagnostic Ultrasounds.....................................................
L eltekU ltrasoundIm aging About This Manual T hisdocum entcontainsthefollow inginform ation: • AbouttheL eltekU ltras oundIm agingS ystem : Des cribestheproduct,liststechnical specifications,anditsintendeduse. • A Q uickT our:S how syou how togets tartedandbegin scanning. •U s ingtheL eltekU ltras ound Im agingS ystem : Introducesyou tothefeaturesandconcepts, helpsyou setupyours ys tem ,andexplains thetasksyou canperform . • Cleaning& Dis infecting:Explainshow tocleanand dis infectyourS ystem .
L eltekU ltrasoundIm aging Document Conventions Icons Icon Description This icon indicates information material or helpful suggestions. Note Caution Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings, cautions and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Symbols Symbols Description/Function ConsultO peratorsM anual Electricalprotection.
L eltekU ltrasoundIm aging IndicatestheAuthorizedrepresentativeintheEuropeanCom m unity. Fragileandhandle carefully.Indicatesam edicaldevicethatcanbebroken ordam agedifnothandledcarefully. Non-sterile Keepdry.Itm eansam edicaldevice w hichneedstobe protected from m ois ture. Indicatessm edicaldevicethatshouldnotbeusedifthepackagehasbeen dam agedoropened. Atm osphericpressurelim itation Indoorus e only.T o identify electricalequipm entdesignedprim arily for indooruse.
L eltekU ltrasoundIm aging Chapter 1 About Leltek Ultrasound Imaging System AboutT hisU serM anual Product Name Model Leltek Ultrasound Imaging System Leltek ULTRASOUND IMAGING SYSTEM LU700 • P leas ereadandunderstandallins tructionsinthisU s erM anualbeforeattem pting tooperatetheL U 700 equipm ent. • KeepthisU serM anualw iththeproductforfuturereference. • S om eoptionsorfeaturesm ay notbeavailableinsom ecountries .
L eltekU ltrasoundIm aging About Leltek Ultrasound Imaging System Install,operate,andm aintainthisproductaccordingtothesafety andoperatingprocedures inthism anual,andonly foritsintendedpurpose.Alw aysus etheinform ation inthis docum entw ith s oundclinicaljudgm entandbes tclinicalprocedures . T hisproductissubjecttothelaw inthejurisdictionthattheproductisused.Ins tall,use,and operatetheproductonly in w aysthatadheretoapplicablelaw sorregulations,w hich have theforceoflaw.
L eltekU ltrasoundIm aging • N everattem ptto openatransduceroratransducerconnector.T hisw ill avoidthew arranty. • P robesarenotdelivered s terilebeforethefirstus ,it’sM AN DAT O R Y toclean anddisinfectprobestoavoidinfectionsordis easetransm iss ions . • P robesm us tbecleanedanddisinfectedbeforethey arereplaced or disposed of. • Ifanuserlos thim /hertablet／sm artphone,thes tored datacannotbe recovered. • DoN O T touchthepatientw ith Androidm obiledevicew henauserusesthe L U 700.
L eltekU ltrasoundIm aging Ultrasound Gels U ltrasoundgelisatypeofconductivem edium thatenablesatightbondbetw eentheskin andtheprobeortrans ducer,lettingthew avestransm itdirectly tothetissuesbeneathand tothepartsthatneedtobeim aged.Itisform ulatedtoactasacouplingagentandreduce static. U ltrasonicgelisusually com posedofpropyleneglycol,w aterand occasionally adye.T hedye ism oreforlooksthanm akingitw orkbetter.Itisus ually clearandthick,andalittlebitsticky.
L eltekU ltrasoundIm aging LU700 Ultrasound Imaging System Description The LU700 Ultrasound Imaging System is a portable, general purpose, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) Android mobile device. I. The imaging system software runs as an app on a mobile device. II.
L eltekU ltrasoundIm aging The LU700 Ultrasound System included BATTERY Ultrasound Beamforming & Processing Tx/Rx Analog Interface Wi-Fi Enable User’s Smart phone OR Tablet Transducer Stack Ultrasound Probe User Interface(APP) for Display P9
L eltekU ltrasoundIm aging Battery Specification Item Des cription Capacity Battery L ife M anufacture M odel CellT ype Dim ens ions S afety S pecification R echargeableL i-ionBattery P ack 6000m Ah 300 dischargecycle DongGuanAlphaEnergy T echnology Co., L td. 1036B7 P rism aticcell 120m m *36m m *10.5m m U N 38.
L eltekU ltrasoundIm aging Leltek Ultrasound Imaging App P robe L 10-5 L inear Array type:L inear N um berofelem ent:128 Depth(cm ):6.0 Frequency bandw idth(M Hz):5.0 – 10.0 CenterFrequency:7.5M Hz B m ode,M m ode,ColorDoppler,P W Doppler C5-2 Convex Array type:Curvilinear N um berofelem ent:128 Depth(cm ):18.0 Frequency bandw idth(M Hz):2.0 – 5.0 CenterFrequency:3.
L eltekU ltrasoundIm aging Chapter 2 Product Usage Indication for Use T heL U 700 U ltrasoundIm agingS ys tem isasoftw are-basedim agingsystem andaccess ories intended forus e by qualitied phys iciansand healthcare professionalsw ho hasthe ability to conductultrasound s can processforevaluation by ultrasound im aging system orfluid flow analysisofthe hum an body.
L eltekU ltrasoundIm aging System: Leltek LU700 Ultrasound Pulsed Echo System Ultrasound Pulsed Doppler Imaging System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific B M PWD CWD Color Combined Other* (Track 1) (Track 1 & 3) Doppler (specify) Ophthalmic Ophthalmic Fetal Imaging & Fetal Other Abdominal N N N N Intra-operative(Specify) Intra-operative(Neuro) Laparoscopic Pediatric Small organ (specify) Ne
L eltekU ltrasoundIm aging System: Leltek LU700 Transducer: C2-5 Convex 3.
L eltekU ltrasoundIm aging System: Leltek LU700 Transducer: L10-5 7.
L eltekU ltrasoundIm aging • • • • • • • The patient's diagnostic environment in circumstances may negatively impact the system and the exam. For example: (1) Chemicals and gases in the operating room. (2) Altitudes below -382 m or above 4000 m. Biological incompatibility may exist between the system materials used and the biological tissues, cells, and body fluids of the patient/user, taking account of the intended purpose of this system.
L eltekU ltrasoundIm aging Contraindications Donotus etheL eltekU ltras oundIm agingS ys tem todofollow ingsituationsthen resultinthethatproduceim agesw ithinaccurateresults: • • • • • • • P atientsw hohavehads urgery,w hichm ay havechangedthe com pos ition oftheexam iningtissue,asthiscouldskew oralterthe m easured dens ity. P atientsw hos ebodiescontainforeignartifacts(forexam ple,im plants),in theexam iningtiss ue. Intra-operativeus e(e.g.
L eltekU ltrasoundIm aging Hardware Purchases and Upgrades • • T heequipm enthasalifetim eof3 years . T o orderadditionalsuppliesandaccessories,gotow w w.leltek.com and contact L eltek. Warranty • T hisequipm entincludesaone-yearw arranty.T opurchaseextendedw arranty program s,gotow w w.leltek.com andcontactL eltek. • L eltekhasbeensupportingandprotectingthenaturalenvironm ent.T he equipm entisdesignedand m anufacturedaccordingto environm entalprotection guidelines.
L eltekU ltrasoundIm aging Security Information security • W henusingL eltekU ltrasound App,itistheuser'sresponsibility toprotecttheir ow n s ecurity credentials(e.g.passw ords)andthepatient'spersonainform ation (e.g.nam eand soon). Network Security • W erecom m endthatusersecuresthisnetw orkusingW P A (W i-FiP rotected Access).U serw illbetrainedm edicalprofess ionals(e.g.,doctors ,nurses, technicians)w ithprevioustraininginultras ound.
L eltekU ltrasoundIm aging Confidentiality T heconfidentialinform ationisassuredasfollow s: • T hes cannercontainsnopatient-identifiableinform ation. • W henthes cannerconnectstoaw irelessnetw ork,itencryptsand storestheW i-Fipas sw ord. • T hedatatrans ferredbetw eenthesm artdeviceandtheL eltek U ltras oundAppisencrypted. • Im agedatacontainsnopatientorus eridentifiableinform ationandis transm ittedinunencryptedform .
L eltekU ltrasoundIm aging Technical Features T herearesom eofthetechnicalaspectsofthes ys tem asfollow inglis t: • • • • • • • • • • • • • • • • • W i-Fi802.11b/g w irelessconnect R eceivefrequency and/orbandandbandw idthofreceiving section. T ransm itfrequency and/orband,m odulation,andER P U S B 3.
L eltekU ltrasoundIm aging Chapter 3 Safety P leasereadthisinform ationbeforeoperatingyourultrasoundsystem .Itapplies tothe device,thetransducers,andthesoftw are.T hissectioncoversgeneral s afety inform ationthatappliesonly to aspecifictaskandisincludedinthe procedureforthattask.P leasefollow thefollow ingrequirem ents: Product Safety L eltek takesthe responsible forthe s afety ofthe equipm ent.T okeepasafety ofthe s m artdeviceisaus erres ponsibility.
L eltekU ltrasoundIm aging • You areresponsibleforconfiguringyourdeviceinaccordancew ithyour ins titution'ssecurity policies .N otificationsandalertsfrom third-party applicationsm ay interferew ithanexam . • Donotusethes ys tem forany applicationuntilyou areadequately and properly trainedonitssafeandeffectiveoperation.Ifyou areunsureof yourability to operatethesys tem safely andeffectively,donotus eit.
L eltekU ltrasoundIm aging Equipment Protection Follow thes e w arningsto protectyoursys tem : • • • • • • • DO N O T im m ers etheprobeintoany liquidbeyondtheim m ersionlevel. N everim m ers etheprobeconnectorintoany liquid. DO N O T droptheprobeorsubjectthem toothertypesofm echanicalshock orim pact.Degradedperform anceordam agesuchascracksorchipsinthe housingm ay result. DoN O T m odify thisdevicew ithoutauthorizationoftheL eltek. DoN O T usetheprobew ithhighfrequency surgicalequipm ent.
Electrical Safety T hetransducerandsoftw are,alongw itharepres entativedevice,havebeenverifiedas com pliantw ithIEC 60601-1.T hetransducersm eetT ypeBFisolatedappliedpartrequirem ents . W henthetransducerandsoftw areareusedinconjunction w ithadevicecom pliantw ithIEC 60950-1,the s ys tem m eetsIEC 60601-1 requirem entsforClassII/internally pow ered equipm ent.(T hesafety s tandardsm etby thiss ys tem areincludedinthe“ S pecifications” section.
• T hes ingcables,transducers ,andaccessoriesotherthanthosespecifiedforuse w iththes ys tem m ay res ultinincreasedem is sionsfrom ,ordecreasedim m unity of, thes ys tem . U seofthes ys tem inthepresenceofanelectrom agneticfieldcancausem om entary degradationoftheultrasoundim age.W heninterferenceispres entorinterm ittent, usecaution w hencontinuingtous ethes ys tem .Ifinterferenceoccursoften,review theenvironm entinw hichthesys tem isbeingusedtoidentify poss iblesourcesof radiated em is sions.
Thermal safety Keepasafety therm alenvironm entforthepatientalw aysbeenadesignpriority atL eltek. T he operatingtem peratureoftheultrasound probem ustrem ainbelow 43°C Biological Safety T hiss ectioncontainsinform ationaboutbiologicalsafety andadis cuss ionoftheprudent us eofthesys tem . Do notus eas ys tem thatexhibitserraticorinconsis tentim ageupdating.Discontinuities inthescanningsequenceindicateahardw arefailurethatm us tbecorrectedbeforeuse.
advisingpatientsw ithseverelatex sens itivity tow earam edicalidentification bracelet. Bioeffects Biological effects of ultrasoundare the potential biological consequences due to the interaction betw eenthe ultrasound w ave and the scanned tissues.Concern aboutthe safety ofultrasound prom pted severalagenciesto devise regulatory lim itson the m achine output intensities.T he visualdisplay oftherm aland m echanicalindicesduring ultrasound im aging providesanaidtolim ittheoutputofthem achine.
Cavitation T heinteractionofultrasound w ithgasbubblesorcontrastagentscausesrapid and potentially largechangesinbubblesize.T hisprocess,term ed cavitation,m ay increasetem peratureand pressurew ithinthebubbleand thereby causem echanicalstressonsurroundingtissues , precipitatefluid m icrojetform ation,andgenerate freeradicals[5].Gas-containingstructures(e.g., lungs,intestines)arem ostsusceptibletotheeffectsofacousticcavitation.
us ingtoolow alevelm ay res ultinpoordataandtheneed torepeattheexam ination.U sing toohighalevelm ay notneces sarily increasethequality oftheinform ation,butitw illexpos e thepatienttounneededultras oundenergy.T heus eofAL AR A isaw ay ofim plem entingsafety as surance.T hethres holdfordiagnos ticultrasound bioeffectsisundeterm ined.U ltim ately,the exposuretim edependsonthepersonconductingtheexam ination.
• U ltrasoundexposuretim e.Exposuretim eisanespecially us efulvariable,becauseitis controlledby theus ers. Acoustic Output Limits • • • IS P T A ≤ 720 mW/cm spta.3 M I≤ 1.9 T I≤ 6.0 Applying ALARA T hes ys tem im agingm odeoftheoperatorselectedthatisdependsontheuserinform ation needed.U nders tandingthenatureoftheim agingm odeused,thetransducerfrequency, s ys tem setupvalues ,s canningtechniques,and operatorexperienceallow thesonographerto m eetthedefinition oftheAL AR A principle.
R eceiverControls R eceivercontrolsareusedby theoperatorto im proveim agequality.T hesecontrols havenoeffectonoutput.R eceivercontrolsonly affecthow theultrasoundecho is received.T hesecontrolsincludegain,tim egain com pens ation (T GC),dynam ic range,andim ageprocess ing.T heim portantthingtorem em ber,relativetooutput, isthatreceivercontrolsshouldbeoptim izedbeforeoutputisincreas ed.For exam ple,beforeincreas ingoutput,optim izegaintoim proveim agequality.
Output Display T herearetw otypesofindicesm ightbedisplayed:oneism echanicalindex(M I)andthe otheristherm alindex(T I).T hem echanicalindex(M I)providesanindicationoftheris k duetom echanicalornontherm alm echanis m s.T hetherm alindex(T I)providesan indication oftheris kofharm duetotherm alm echanism s.T hem echanicalindex(M I)is continuous ly displayedovertherangeof0.0 to1.9,inincrem entsof0.1. T hetherm alindex furthercons is tsofthefollow ingindices :softtis sue(T IS ),bone(T IB), andcranialbone(T IC).
Thermal Index (TI) Displays T herearethreeT Isw hich us ed fordifferentcom binationsofs oft tiss ueand boneintheareatobeexam ined.T heT Iisintendingtokeep usm aking aw areofconditionthatcauseincreasedtem peratureelevations ,nom atterat surface,w ithinthetissue,oratthepointw heretheultras oundisfocusingonbone.
• • • Application:Acous ticoutputdefaultsaresetw henyou selectanapplication. Factory defaultsvary w ithtransducer,application,and m ode.Defaultshave been chosen below theFDA lim itsforintendeduse. Im agingM odeControls:W henanew im agingm odeisselected,boththeT I andM Im ay changeto defaultsettings.Eachm odehasacorrespondingpulse repetitionfrequency andm axim um intensity point.
January 28,1993,providesm ore-currentinform ation.
Chapter 4 Device Maintenance Itisyourres ponsibility toappropriately cleananddisinfectyourL U 700-com patibles m art deviceinaccordancew iththedevicem anufacturer'sins tructionsand w ithyourins titution's policiesforcleaninganddisinfectingofm edicaldevices . IftheL U 700-com patiblesm artdevice becom escontam inatedinternally w ithbodily fluids containingpathogens,you m us tim m ediately notify yourL eltekservicerepresentative. Com ponentsins idethedevicecannotbedisinfected.
U singnon-recom m endeddis infectants ,usingincorrectsolutionstrengths,orim m ers inga transducerdeeperorlongerthanrecom m endedcandam ageordis colorthetransducerand voidsthetransducerw arranty. Cleaning & Disinfecting Itisim portanttocleananddis infecttheultrasoundprobeim m ediately afteruse.T hischapter w illguideyou throughthecleaninganddis infectingprocess . W hencleaninganddis infecting: • Follow theproceduresintheorderthey aredes cribedinthisguide,w ithoutskipping s teps.
• Its hallinspecttheprobe’slensandcas ingaftereachus e.T ocheckout any dam age thatw ouldallow liquidtoentertheprobe.Iftheuserfoundaprobedam age,theprobe m ustnotbeplacedintoany liquid(e.g.,fordisinfection)andm ustnotbeus eduntilit hasbeeninspectedandrepaired/replaced by aL eltek'sagentforservice. R ecom m endationsfordisinfectingtheultrasoundprobe(Aftercleaning): • S pray disinfectontothesurfaceofprobehead. • R epeats tep onefortw o orthreetim es. • L ets tandforabout1 m inute.
Chapter 5 Regarding Diagnostic Ultrasounds Interactions of Ultrasound with Matter Asanultrasoundpuls epassesthroughm atter,such ashum antissue,itinteractsinseveraldifferent w ays.S om eoftheseinteractionsareneces sary toform an ultrasoundim age,w hereasothersabsorb m uch oftheultrasoundenergy orproduceartifactsand aregenerally undesirablein diagnostic exam inations .T heability toconductandinterprettheres ultsofanultrasound exam inationdepends on athorough unders tandingoftheseultrasoundinteractions .
LU700 Device Operation Overview of the Interface • • • P leasem akesuretohavefullbattery pow eronyoursm artdeviceby chargingitregularly. P leasedow nloadtheL eltekL U 700 A ppas"L EL T EK"from Android App s tore. S tartapp"L ELT EK". L ELT EK • T hes oftw arevers ionw illbedisplayed ontherightuppercornerofthescreen asbelow figure.
IfthescannerdoesN O T m oveforapprox.,25 seconds,theL U 700 Appscreen w illbefreezeandthe L ED iss tillw hite. Starting New Exams 1. R EVIEW :T heusertouchesthisbutton,thesystem w illlinkto page"S avedExam "andcouldbereview ing previously savedtestdata. 2. EX IT :T heusertouchesthefunctionbutton toexitfrom App "LELTEK". 3. :T hetransducersthatw illbere-autodetectedto beconnectedviaW i-Fi. 4.
1. T ocreateatem porary Q uickID andstartscanningim m ediately,touch S CAN .T he 2. 3. 4. im agingdisplay appears,andyou can beginscanning. T otouch Q uickID m anually enterpatientinform ationbeforeyou beginscanning,touchandpresenta screenforEditionP arentInfo". By thepageof"EditionP atientInfo",itw ouldeditapatientrelatedinform ationthen pressthebutton"S ave" w hich isonthescreenoftherightuppercornertodosave. T ouchFR EEZE,thesystem isstoppingtheim ageduringthescanning;orre-activatingthestoppedim age.
5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. thearea. T ouchB,thesystem w ouldbeselectedforB m odew hichm eansatw o-dim ensionalultrasoundim agedisplay com posed ofbrightdotsrepresentingthe ultrasound echoes. T ouchCF,thesystem w ouldbeselectedforCFm ode,thevelocity anddirectionofbloodflow saredepicted inacolorm apsuperim posedon the2-D im age.Colorflow isshow ed in R O I. Itssizeandlocation are adjustable.
Chapter 6 References Compliance Statement L eltek productscom ply w ith internationaland nationals tandardsand law s .U sersare responsible forensuring that the chosen sm artdevice and scannerare com pliant w ith the law in the jurisdiction w here the product isused. L eltek m eetsallregulatory standardslis tedinthischapter.
System Specifications • • Gray shades :256 inB-M ode P res sure,hum idity,andtem peraturelim its :T heselim itsapply only totheL eltektransducer, nottotheAndroiddeviceonw hichtheuserruntheL eltekim agingS ys tem app.Itistheus er's respons ibility toselectaL eltek-com patibledevicethatm eetstheneedsoftheuser'sclinical environm ent. Forinform ationabouttheuser'sdevice'senvironm entalspecifications,consultthe docum entationthataccom paniesus ers'device.
Standards Acoustic IEC 60601-2-37:2007 -M edicalelectricalequipm ent -P art 2-37:P articularrequirem entsforthe bas ic safety and es sentialperform ance ofultrasonic m edicaldiagnos ticand m onitoring equipm ent Biocompatibility AN S I/IS O 10993-1:2009 -Biologicalevaluation ofm edicaldevices-P art 1: Evaluation andtes tingw ithinariskm anagem entprocess.
Wireless ET S IEN 300 328 V2.1.
Acoustic Output Tables C2-5 Transducer Acoustic Output Reporting Table for Track 3 : Transducer ModelC2-5, B-Mode Operation, Probe with 3.6MHz Index Label MI TIS Scan 0.727 Global Maximum Index Value Associated Acoustic Parameter Other Information Operating Control Conditions TIB Non-scan Nonscan Aaprt ≤ 1 2 cm Aaprt > 1 2 cm 0.011 - - 2.93 - Pr.
Note 1. No TIS formula information is required for the maximum TIS value in this mode. 2. No information about TIC is required for any transducer assembly that is not used for the head of a transcranial or neonatal 3. If the device meets the 51.2aa) and 51.2dd) exemptions, no MI or TI information is required. (a) The intended use does not include the head, so the TIC is not calculated.
L10-5 Transducer Acoustic Output Reporting Table for Track 3 : Transducer ModelL10-5, B-Mode Operation, Probe with 7.1MHz MI TIS Scan TIB Non-scan Aaprt ≤ 1 cm 0.712 Global Maximum Index Value Associated Acoustic Parameter Other Information Operating Control Conditions Aaprt > 1 2 TI C Nonscan cm2 0.0105 Pr.a (MPa) P (mW) Pα(zs) min and Ita,α( zs)min (m W ) zs (cm) zbp (cm) - zb (cm) - zmax of Ipi, α (cm) dep(zb) (cm) faw f (MHz) Dim. of Aaprt X (cm) 0.
ID Label Guidance and Manufacture's Declaration • L U 700 requiress pecialprecautionsregardingEM C. • L U 700 shouldnotbeusedadjacenttoors tackedw ithotherequipm ent.
Electromagnetic Emissions T heL U 700 isintended foruseinelectrom agneticenvironm ents,asspecified below.T hecustom erortheuseroftheL U 700 should ensurethatitisused in suchanenvironm ent. Manufacturer’s declaration-electromagnetic emissions The LU700C, LU700L is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the LU700C, LU700L should assure that it is used in such an environment.
Electromagnetic immunity All L U 700 seriesproductarein com pliancew iththeregulationof Manufacturer’s declaration-electromagnetic immunity The LU700C, LU700L is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the LU700C, LU700L should assure that it is used in such an environment.
Manufacturer’s declaration-electromagnetic immunity The LU700C, LU700L is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the LU700C, LU700L should assure that it is used in such and environment.
Recommended separation distance between portable and mobile RF communications equipment and the LU700C, LU700L The LU700C, LU700L is intended for use in an electromagnetic environment (for professional healthcare) in which radiated RF disturbances are controlled.
Manufacturer’s declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The LU700C, LU700L is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the LU700C, LU700L should assure that it is used in such an environment.
Trouble Shooting: Issue Solution LED indicator flashing and could not turn When low battery state, please does use off device. adapter to charge device then could turn Note off the device. Wi-Fi could not be connected. a. When LED indicator of the device(transducer) is purple, the device(transducer) may be low battery state and need to be charged by an adapter. b.
Federal Communications Commission (FCC) Statement 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. 15.105(b) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
