Enraf-Nonius Physisonic ES-7 OG User manual

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Ultrasound Therapy Equipment Model
ES-7
For Professional Use
PHYSISONIC
Instruction manual
About this Manual
zKeep this manual in a safe place where it can be referred to whenever necessary.
zIf this manual becomes lost or damaged, contact your OG Wellness Technologies
distributor immediately.
zFollow the instructions and procedures specied in this manual.
zDo not operate, care for or provide maintenance for the product except as specied in
this manual.
zThe contents of this manual and caution labeling on the product may not cover all
potential dangers associated with the product.
OG Wellness is unable to foresee dangers arising from any use of the product other than its intended use.
zKeep safety considerations in mind when using, cleaning or inspecting the product,
including, but not limited to the contents of this manual and caution labeling on the
product.
zThe product you have purchased may dier in some details from the illustrations in
this manual. Parts of the illustrations in this manual may be omitted or simplied to aid
explanation.
zThe specication and design of the product, as well as the contents of this manual are
subject to improvement and change without notice.
zFor inquiries or further information, contact your OG Wellness Technologies distributor.
zGreat care has been taken in the preparation of this manual. In the event of any error or
omission, or if any of the contents are unclear, please contact your OG Wellness
Technologies distributor.
zOG Wellness Technologies holds the copyright of this manual.
zIt is prohibited to copy, edit or translate all or any part of this manual without the prior
written consent of OG Wellness Technologies.
zDo not copy the contents of this manual via any electronic reading or scanning device
including, but not limited to, image scanners.
zCompany names and product names described in this manual are trademarks or
registered trademarks of their respective companies in Japan and other countries.
zIf the use of this device may have caused or contributed to an adverse event such as
death or serious injury to the user then, the manufacturer and the competent authority
of the Member State MUST be notied immediately.
Table of Contents
1. Product Description --------------------------------------------------------------------------------------- 4
2. Foreword ------------------------------------------------------------------------------------------------------ 4
2. 1 Productliability ------------------------------------------------------------------------------------------------- 4
3. Precautionary Instructions ------------------------------------------------------------------------------ 5
4. Intended Use and Intended User ---------------------------------------------------------------------- 6
4. 1 Indications/contraindicationsandadverseeects --------------------------------------------------- 6
4.1.1 Indications ------------------------------------------------------------------------------------------------------6
4.1.2 Contraindications ----------------------------------------------------------------------------------------------6
4.1.3 Potentialadverseeects ------------------------------------------------------------------------------------6
4.1.4 Sideeects -----------------------------------------------------------------------------------------------------6
4.1.5 Relevanthazards ---------------------------------------------------------------------------------------------6
4. 2 Denitionsofsymbols ---------------------------------------------------------------------------------------- 7
4. 3 Ultrasoundparameters--------------------------------------------------------------------------------------- 8
5. Package Contents ------------------------------------------------------------------------------------------ 8
6. Application Notes ------------------------------------------------------------------------------------------ 9
6. 1 Contactcontrol ------------------------------------------------------------------------------------------------- 9
6. 2 Thecontactmedium ------------------------------------------------------------------------------------------ 9
6. 3 Beforetreatment ----------------------------------------------------------------------------------------------- 9
6. 4 Startingtreatment --------------------------------------------------------------------------------------------- 9
6. 5 Duringtreatment ----------------------------------------------------------------------------------------------- 9
6. 6 Endingtreatment ---------------------------------------------------------------------------------------------10
6. 7 Aftertreatment ------------------------------------------------------------------------------------------------10
7. Installation -------------------------------------------------------------------------------------------------- 11
7. 1 Inspection ------------------------------------------------------------------------------------------------------11
7. 2 Requirementsforinstallation ------------------------------------------------------------------------------11
7. 3 Mountingtheultrasoundheadholder -------------------------------------------------------------------11
7. 4 Connectiontopowersupply -------------------------------------------------------------------------------11
7. 5 Switchingonandself-test ---------------------------------------------------------------------------------- 11
7. 6 Disconnectionofpowersupply ---------------------------------------------------------------------------11
8. Operator Controls ---------------------------------------------------------------------------------------- 12
9. Operation ---------------------------------------------------------------------------------------------------- 14
9. 1 Turnontheapparatus --------------------------------------------------------------------------------------- 14
9. 2 Homemenu ----------------------------------------------------------------------------------------------------14
9. 3 Systemsettings -----------------------------------------------------------------------------------------------14
9.3.1 Setlanguage ------------------------------------------------------------------------------------------------- 14
9.3.2 Setbrightness ------------------------------------------------------------------------------------------------ 15
9.3.3 Systeminfo --------------------------------------------------------------------------------------------------- 15
9.3.4 Ultrasoundnorm --------------------------------------------------------------------------------------------- 15
9. 4 Loadclinicalprotocols---------------------------------------------------------------------------------------16
9. 5 Manualoperation ---------------------------------------------------------------------------------------------17
9.5.1 Ultrasoundfrequency -------------------------------------------------------------------------------------- 17
9.5.2 Continuous/pulsedmode -------------------------------------------------------------------------------- 17
9.5.3 Pulsefrequency --------------------------------------------------------------------------------------------- 18
9.5.4 Dutycycle ----------------------------------------------------------------------------------------------------- 18
9.5.5 Applicatorselection(Onlywhenapplicatorsaremountedatbothrightandleftsides) --- 19
9.5.6 Units ------------------------------------------------------------------------------------------------------------ 19
9.5.7 Treatmenttime ----------------------------------------------------------------------------------------------- 20
9.5.8 Intensitysetting ---------------------------------------------------------------------------------------------- 20
9. 6 Storingprotocols----------------------------------------------------------------------------------------------21
9.6.1 Loadprograms ----------------------------------------------------------------------------------------------- 22
10. Maintenance and Troubleshooting ----------------------------------------------------------------- 23
10. 1 Usermaintenance -------------------------------------------------------------------------------------------- 23
10.1.1 Cleaningofapparatus ------------------------------------------------------------------------------------- 23
10.1.2 Cleaningdisplaypanel------------------------------------------------------------------------------------- 23
10.1.3 Ultrasoundapplicator -------------------------------------------------------------------------------------- 23
10.1.4 Disinfection --------------------------------------------------------------------------------------------------- 23
10. 2 Troubleshooting ----------------------------------------------------------------------------------------------- 23
10. 3 Technicalmaintenance--------------------------------------------------------------------------------------24
10.3.1 Restorecontactcontrolandrestorefactorydefaults ----------------------------------------------- 24
10. 4 Disposal ---------------------------------------------------------------------------------------------------------24
11. Specications --------------------------------------------------------------------------------------------- 25
11. 1 Ultrasound parameters --------------------------------------------------------------------------------- 25
11.1.1 Continuousoutputultrasound---------------------------------------------------------------------------- 25
11.1.2 Pulsedoutputultrasound---------------------------------------------------------------------------------- 25
11. 2 Safetyandperformancestandards ----------------------------------------------------------------------27
11. 3 EMCdetails ----------------------------------------------------------------------------------------------------28
11. 4 Technicaldata -------------------------------------------------------------------------------------------------31
12. Common Terms Used ----------------------------------------------------------------------------------- 32
13. Consumable Parts --------------------------------------------------------------------------------------- 32
14. Warranty and Disclaimer ------------------------------------------------------------------------------- 33
15. Supplementary Information --------------------------------------------------------------------------- 34
4
1. Product Description
Beingamulti-frequencyultrasoundtherapyequipment,themountedapplicatorsprovideboth1and
3MHzoperationwithoutchangingtheapplicator.Dependingontheareaoftreatment,twodierent
typesofapplicators,largeandsmall,canbeused.Theseapplicatorsareevensuitablefortreatment
underwater.WhenusingoptionalaccessoriesStatUS,theapplicationofultrasoundwithoutmoving
(=stationary)theultrasoundtreatmentheadcanbedone.Seetheinstructionmanualaccompanying
theStatUSforES-7fordetailsregardingstandardandoptionalaccessories.
ES-7comeswithanadditionalfeature“Contactcontrol”.Whenthereispooracousticalcontactwiththe
treatmentarea,thecontactcontrolsuspendstheapplicationofultrasoundenergy,therebypreventing
reducedtherapeuticeectofthesoundwaves,andoverheatingofsoundhead.
2. Foreword
2. 1 Product liability
AlawonProductLiabilityhasbecomeeectiveinmanycountries.
ThisProductLiabilitylawimplies,amongstotherthings,thatonceaperiodof10yearshaselapsed
afteraproducthasbeenbroughtintocirculation,themanufacturercannolongerbeheldresponsible
for possible shortcomings of the product.
Tothemaximumextentpermittedbyapplicablelaw,innoeventwillOGWellnessTechnologies,Enraf-
Noniusortheirsuppliersorresellersbeliableforanyindirect,special,incidentalorconsequential
damagesarisingfromtheuseoforinabilitytousetheproduct,including,withoutlimitation,damages
forlossofgoodwill,workandproductivity,computerfailureormalfunction,oranyandallother
commercialdamagesorlosses,evenifadvisedofthepossibilitythereof,andregardlessofthelegalor
equitabletheory(contract,tortorotherwise)uponwhichtheclaimisbased.
Inanycase,OGWellnessTechnologiesand/orEnraf-Nonius’sentireliabilityunderanyprovisionofthis
agreementshallnotexceedintheaggregatethesumofthefeespaidforthisproductandfeesfor
supportoftheproductreceivedbyEnraf-NoniusorOGWellnessTechnologiesunderaseparate
supportagreement(ifany),withtheexceptionofdeathorpersonalinjurycausedbythenegligenceof
OGWellnessTechnologiesorEnraf-Noniustotheextentapplicablelawprohibitsthelimitationof
damages in such cases.
Theopposingparty(product’suseroritsrepresentative)shalldisclaimOGWellnessTechnologiesand
Enraf-Noniusfromallclaimsarisingfromthirdparties,whatevernatureorwhateverrelationshiptothe
opposing party.
5
3. Precautionary Instructions
D WARNING :
•Itisimportantthatyouinspectyourgoodsfordamagewhenreceived.Thedevicemustnotbeused
before inspection is complete.
•Thedeviceshouldnotbeusedwhenanysortofmechanicaldamageisnoticed.
•Thisdeviceshouldbeusedonlyunderthecontinuedsupervisionofaphysicianorlicensedpractitioner.
•Keep yourself informed of the contra-indications.
•Makecertainthattheunitiselectricallygroundedbyconnectingonlytoagroundedelectricalservice
receptacle conforming to the applicable national and local electrical codes.
•Useofaccessories,transducers,andcablesotherthanthosespeciedorprovidedbythe
manufacturerofthisequipmentcouldresultinincreasedelectromagneticemissionsordecreased
electromagneticimmunityofthisequipmentandresultinimproperoperation.
•Useofcontrolsoradjustmentsorperformanceofproceduresotherthanthosespeciedhereincould
resultinhazardousexposuretoultrasoundenergy.
•Caremustbetakenwhenoperatingthisequipmentaroundotherequipment.Potential
electromagneticorotherinterferencecouldoccurtothisortotheotherequipment.Trytominimize
thisinterferencebynotusingotherequipmentinconjunctionwithit.
•Thisdeviceisnotsuitableforuseinthepresenceofammableanestheticsmixturewithair,oxygen,
ornitrousoxide.
•Thisproductisnotintendedforuseinso-called“wetrooms”(hydrotherapyrooms).
•Thisdeviceshouldbekeptoutofthereachofchildren.
•Itisrecommendedthatthisproductshouldnotbeusedafterextremetemperatureuctuations.
•ItisMANDATORYtohavetheES-7checkedannuallybyauthorizedpersonnelofEnraf-Nonius,OG
Wellnessorbyitsauthorizeddistributor.
D CAUTION :
•Handleultrasoundapplicatorwithcare.Inappropriatehandlingoftheultrasoundapplicatorcould
degradeaectitscharacteristics.
•Alwaysdeterminethedosagebasedonthepatient’sperceptionofheat.Anysensationgreaterthan
mildwarmthcouldcauseaburn.
•Inspectultrasoundapplicatorforcracksandothermechanicaldefectswhichmayallowtheingressof
conductiveuidbeforeeachuse.
•Donotoperatethisproductwhenconnectedtoanyunitotherthanourproducts.
•Thisunitshouldbeoperatedintemperaturesbetween10°Cand40°C(50°Fand104°F),witha
RelativeHumidityrangingfrom10%-90%(non-condensing).
•Donotexposetheunittodirectsunlight,heatradiatedfromaheatradiator,excessiveamountsof
dust,moisture,vibrationsandmechanicalshocks.
•Inthecaseofingressofliquids,unplugtheunitfromthemainssupplyandhaveitcheckedbyan
authorizedperson.(Seetheparagraphontechnicalmaintenance)
•Beforeadministeringanytreatmenttoapatient,youshouldbecomeacquaintedwiththeoperating
proceduresforeachmodeoftreatmentavailable,aswellastheindications,contraindications,
warningsandprecautions.Consultotherresourcesforadditionalinformationregardingtheapplication
of ultrasound therapy.
6
4. Intended Use and Intended User
Thisproductisaunitforcontinuousandpulsedultrasoundtherapy.
ThisproductisdesignedtoONLYbeusedbyorunderthesupervisionofcompetentpersonnelin
physiotherapy,rehabilitation,oradjacentareas.
4. 1 Indications / contraindications and adverse
eects
4.1.1 Indications
Reliefofpain,subtlemassagingeect,musclespasmsandjointcontracturesusingheatfrom
ultrasound and nonthermal biological reactions.
4.1.2 Contraindications
•Theestablishedcontraindicationstoheattherapyitself.
•Inanareaofthebodywhereamalignancyisknowntobepresent.
•Overornearbonegrowthcentersuntilbonegrowthiscomplete.
•Overthethoracicareaifthepatientisusingacardiacpacemaker.
•Overahealingfracture.
•Overischemictissuesinindividualswithvasculardiseasewherethebloodsupplywouldbeunableto
followtheincreaseinmetabolicdemandandtissuenecrosismightresult.
•Inthepresenceofmetalimplantsofanytype.
•Patientswithsensorylossontheareatobetreated.
•Thegonadsorpregnancy.
•Theheart.
•Thebrains.
•Thetesticles.
•Theeyes.
•Unconsciouspatients.
4.1.3 Potential adverse eects
•Cataracts
•Malesterility
•Enhanceddrugactivity
•Thermalstress
4.1.4 Side eects
Nosideeectsarereportedduetotheuseofthisproduct.
4.1.5 Relevant hazards
D WARNING :
•Useofultrasoundintreatingareasabovetheshoulderscouldposerelevanthazards.
•Whileitisrecognizedthatcertainspecicconditionsinvolvingtheeyescanandhavebeentreatedby
qualiedspecialists,knowledgeandexperiencetoadministersuchtreatments,suchapplication
carrieswithitrecognizedhazardsofapplyingheattotheeyes.
•Treatmentofthefacialsinusexposestheeyestothesamehazards.
•Treatmentofthethyroid,aswellaslymphnodesintheneck,couldexposethepatienttoasyet
undeterminedeectsinasmuchasthesafetyofsuchtreatmentshasnotyetbeenestablished.
7
4. 2 Denitions of symbols
Themeaningsofthesymbolsusedinthisproductareasfollows:
:Followtheinstructionsinthe InstructionsforUse.
ItisMANDATORYthatyouread,understand,andobservetheprecautionaryand
operating instructions.
:GeneralProhibitionSign
Indicatesbehaviouroractionswhicharenotpermitted.
:Indicatesahazardoussituationwhich,ifnotavoided,couldresultin
Deathorseriousinjurytothepatientoroperator
(or)Minortomoderateinjurytothepatientoroperator
(or)Damagetotheequipment
:ThisproductcomplieswithEuropeanUnionMedicalDeviceDirective(93/42/EEC).
:Keepthedevicedry.
:SerialNumber
Indicatesthemanufacturer’sserialnumbersothataspecicmedicaldevicecanbe
identied.
:ReferenceNumberorPartNumber
:IndicatesTypeBappliedparts
NoelectricalcontactwithPatientandmaybeearthed.
:Manufacturername,address,anddateofmanufacture
(YYYY-MM)
:TemperatureLimits
Indicatesacceptabletemperaturerange.
:HumidityLimits
Indicatesacceptablerelativehumidity.
:AtmosphericPressureLimits
Indicatestherangeofatmosphericpressuretowhichthemedicaldevicecanbe
safelyexposed.
:WasteElectricalandElectronicEquipment(WEEE)
Indicatesthatelectricalandelectroniccomponentsofthedevicecanberecycledand
it has to be disposed separately.
8
4. 3 Ultrasound parameters
•UltrasoundFrequency
ItisexpressedinMHz,isthefrequencyoftheultrasoundwaves.Theultrasoundfrequency
determinesthepenetrationdepth,whichhasthelargestvalueat1MHz.Theultrasoundfrequency
canbesetat1MHzor3MHz.
•DutyCycle
Itisexpressedin%,denestheratioofthepulsedurationtothepulserepetitiontime.Thedutycycle
describesthepulsedmodesofultrasound.Thelowerthepercentage,thelowertemporalaverage
intensity.100%iscontinuousultrasound.Thereare6settingsavailable:5,10,20,33,50and80%.
•EectiveRadiationArea(ERA)
Itisexpressedincm²,denesthecross-sectionalareaoftheultrasoundbeam(Seetechnical
specicationsfordetails).TheEectiveRadiationAreaisxedanddenedbythesizeofthe
ultrasound applicator.
•UltrasoundPower
ItistheultrasoundoutputexpressedinW.TheultrasoundoutputdisplaycanbetoggledbetweenW
andW/cm².Inpulsedmodethepowerduringthepulseisdisplayed.Thetimeaveragedpowercanbe
obtainedbymultiplyingthisvaluewiththeDutyCycle.
•UltrasoundAmplitude
ItisexpressedinW/cm²,isthequotientofUltrasoundPowerandEectiveRadiationArea.The
ultrasoundoutputdisplaycanbetoggledbetweenWandW/cm².InpulsedmodetheAmplitude
duringthepulseisdisplayed.ThetimeaveragedAmplitudecanbeobtainedbymultiplyingthisvalue
withtheDutyCycle.
5. Package Contents
•ES-7S1X ES-7withaL-applicator
•ES-7S2X ES-7withaS-applicatorandL-applicator
•ES7-002 StatUSforES-7
NOTE:Thedigit“X”isdeterminedbythekindofpowercord.
Standard accesories for ES-7S1X and ES-7S2X
•L-applicator
•S-applicator(OnlyforES-7S2X)
•Applicatorholder
•ES7-001UltrasoundGel
•Powercord
•Instructionmanual(thismanual)
•Packageinsert
•Instructionmanual(Japaneseversion)
•Informationsheet-MountingUSHeadHolder
ES7-002 : Standard accesories
•CT7-006GelpadStatUS(240x)
•CT7-007FixationringgelpadStatUS(3x)
•Powercord
•InstructionmanualsforES7-002
D CAUTION :
Useofaccessories,transducersandcablesotherthanthosespeciedorprovidedbythemanufacturer
ofthisequipmentcouldresultinincreasedelectromagneticemissionsordecreasedelectromagnetic
immunityofthisequipmentandresultinimproperoperation.
9
6. Application Notes
6. 1 Contact control
Theultrasoundapplicatorhasacontactcontrolfunctionthatsuspendstreatmentwhentheacoustical
contactwiththebodydropsbelowacertainlevel.Theindicatorlightontheapplicatoristurnedonto
signalthissituation.Thedisplaystatussymbolwillshowpause(▌▌)andyouwillhearabeep.During
thissituation,theapplicatoremitsasmallamountofenergytosenserestorationofacousticalcontact.
Youmayexperiencethiswhentheapplicatoronlypartiallycontactsthebody.Whencontactrestoration
is sensed the treatment is resumed at the set amplitude.
6. 2 The contact medium
Toensureecienttransferofenergy,acontactmediumisrequiredbetweentheultrasoundapplicator
andthebody.Aircausesvirtuallytotalreectionoftheultrasoundenergy.Thebestmediumforthe
transferofultrasoundenergyisagel.Thegelshouldbeappliedtothepartofthebodytobetreated
andthenspreadoutwiththeultrasoundapplicator.
Neverapplythegeltotheultrasoundapplicator.Theapplicatorwillregisterthisasacousticalcontact
andmayemitultrasoundenergy,whichcoulddamagetheapplicator.
Ifthebodysurfaceisveryirregular,makingitdiculttoobtaingoodcontactbetweentheultrasound
applicatorandthebody,orifdirectcontactmustbeavoided(e.g.duetopain),theaectedareamay
betreatedunderwater(subaqualmethod).Thewatershouldbedegassed(bypreviousboiling)in
ordertopreventairbubblesarisingontheultrasoundapplicatorandthebody.
6. 3 Before treatment
D CAUTION :
•Pleasemakesureyouhavereadandunderstoodthecontentofthismanualbeforeyoustart
treatment.
•Checkthepatientforanypossiblecontraindications.
•Testthethermalsensibilityofthetreatmentarea.
•Tooptimizeultrasoundtransmission,cleantheskinofthetreatmentareawithsoapora70%alcohol
solution. Stronghairgrowthhastobeshaved.
6. 4 Starting treatment
D CAUTION :
•Positionthetreatmenthead(donotforgettoapplygel).
•Whenadequatecontactismade,thetimerwillstart.
•Whenthecontactbetweenthetreatmentheadandthepatientisnotadequate,LEDring(contact
controlindicator)intheapplicatorheadwillturnon.
6. 5 During treatment
•Thetreatmentheadiskeptinslowcontinuousmotion,alsoforthesemi-staticmethod.
•Duringtreatment,thedisplayedultrasoundamplitudecanvaryaroundthesetvalue,causedby
uctuationsinacousticalcoupling.
•Thepatientisregularlyaskedtoreportanysensationsfelt.Ifnecessary,thetreatmentismodied;
Theintensitycanbereducedoraswitchismadefromcontinuoustopulsedultrasoundorvice-versa.
•Ifthereareindicationsofpoortransferoftheultrasoundenergythecontactmediumcanbereviewed
ifnecessary,addmorecontactgelorspreaditwiththeapplicator.
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D CAUTION :
•Theultrasoundapplicatorisaprecisioninstrument.Greatcarehasbeentakenduringthe
developmentandinproductiontoobtainthebestpossiblebeamcharacteristics.Roughtreatment
(jarringordropping)canadverselyaectthesecharacteristics,andmustthereforebeavoided.
IMPORTANT:
Inordertoensureecienttransferofenergy,acontactmediumisrequiredbetweenthetreatment
headandthebody.Airreectsvirtuallyalloftheultrasoundenergy.Thebestmediumforthetransferof
ultrasound energy is a gel.
Forpreference,useUltrasoundGel(ES7-001),asthisallowstheexcellentcharacteristicsofthe
treatmentheadstobeusedtotheirfulladvantage.
Thegelshouldbeappliedtothepartofthebodytobetreatedandthenspreadoutwiththetreatment
head.
6. 6 Ending treatment
Treatmentcanbestoppedbytakingothetreatmentheadfromthepatientandsettingthetimerto
zero.Treatmentstopsautomaticallywhenthetreatmenttimehaselapsed.
6. 7 After treatment
•Cleantheskinofthepatientandtheultrasoundapplicatorwithatowelortissue.
•Checkfortheeectsthatcanbeexpected(forexamplepain,circulationandmobility).
•Askthepatienttocommentsubsequentlyonanyreactionsthatmayoccur.
D WARNING :
•Duringtreatment,thepatientmaynotfeelunpleasantsensationsamountingtopain.Amildsensation
ofexcitationispermissible.
•If,asresultoftreatment,headache,vertigo,fatigueand/orother(autonomicnervous)reactions
develop,subsequenttreatmentshouldbegivenatalowerintensity.
•With continuous and pulsed ultrasound at high intensity a sensation of heat may be felt. Only a mild
sensationofwarmthisacceptable.
11
7. Installation
7. 1 Inspection
TaketheES-7andanyextrapartsoutofthecardboardpackagingandcheckeverythingforpossible
transport damage.
Verifythatthepackagingcontainsalltheitemslistedinthestandardaccessorieslist(Refertochapter
5,PackageContents).
Priortoconnectionofthisapparatustothemainssupply,checkthatthevoltageandfrequencystated
onthetypeplatecorrespondwiththeavailablemainssupply.
DWARNING:
•DONOTUSEthedeviceincaseanydamagefromtransportisnoticed.Pleasenotifyyoursupplier
immediately.
•Makecertainthattheunitiselectricallygroundedbyconnectingonlytoagroundedelectricalservice
receptacle conforming to the applicable national and local electrical codes.
7. 2 Requirements for installation
DWARNING:
•Iftheunitcannotbeinstalledimmediatelyafterdelivery,theunitanditsexternalcomponentsor
accessoryelementsmustbestoredintheiroriginalpackaginginadryplace.
•Donotstoreoroperatetheunitinadustyenvironment.
7. 3 Mounting the ultrasound head holder
Ultrasoundhead/applicatorholdercanbemountedontherightorleftoftheunit.Followtheinstructions
givenintheInformationsheet-MountingUSHeadHolder.
7. 4 Connection to mains supply
Insertthepowercordintotheconnector[5]andconnectittoawallsocket.Connecttheapplicatorinto
theconnector[7]or[8].
D CAUTION :
•Donotplacetheunitinalocationwherethepowercordcouldbetrippedoverorpulledoutduring
treatment.
•Donotattempttousetheunitifitisnotproperlygrounded.Makecertainthattheunitiselectrically
groundedbyconnectingitonlytoagroundedelectricalservicereceptaclethatisinconformitywith
theapplicablenationalandlocalelectricalcodesregardingmedicalenvironments.
7. 5 Switching on and self-test
SwitchontheunitusingtheON/OFFbutton[4].
Immediatelyafterswitchingon,theunitcarriesoutaself-test.
Checkthat:
AllLED’slightupbriey.
Attheendofthetestabeepcanbeheard.
7. 6 Disconnection of mains supply
Switchtheproductowiththeon/obutton[4].
Unplugtheproductfromthewallsocket.
Disconnectthemainsadapterfromtheproduct.
12
8. Operator Controls
[1]LCDdisplay
ColorTFTdisplay4.3”withtouchscreen
[2]Applicator
UltrasoundapplicatorMulti-frequency1and3MHz
[3]Applicatorholder
Applicatorholdercanbemountedontherightorleftsideoftheunit.
[4]MainsSwitch
Toswitchthedeviceonando.
Whenturningtheunitothedisplayremainsvisibleforafewseconds(low-energymethod).
[5]Connectorforpowercord
Todisconnectthedevicefromthepowerline,unplugthepowercord.
[6]Typenumbersticker
Providesinformationontheapparatus,suchastypeandserialnumber,aswellasconnectiondata
suchasmainsvoltageandmaximumcurrentconsumption.
[7]ConnectorUltrasoundapplicatorA
Ultrasoundapplicatorconnectionleftside
[8]ConnectorUltrasoundapplicatorB
Ultrasoundapplicatorconnectionrightside
[9]ContactControlRingLEDintheApplicator
ThisLEDringemitsyellowcolorlightwhenthecontactbetweenthetreatmentareaandtheapplicator
is poor.
D CAUTION :
•Connectionofaccessoriesotherthantheonesspeciedbythemanufacturercanadverselyaectthe
safetyofthepatientandcorrectfunctioningofthedevice,andisthereforenotpermitted.
•Theultrasoundapplicatorisaprecisioninstrument.Greatcarehasbeentakenduringthe
developmentandinproductiontoobtainthebestpossiblebeamcharacteristics.Roughtreatment
(jarringordropping)canadverselyaectthesecharacteristics,andmustthereforebeavoided.
•Theapplicatortobeusedcanbeselectedintheultrasoundmenu.
•Only1applicatorcanbeactive.YoucannotworksimultaneouslywithapplicatorAandB.
13
[1]
[2]
[3]
[4]
[5]
[6]
[8]
[7]
[9]
14
9. Operation
9. 1 Turn on the apparatus
•Operatethemainswitch[4]toturnontheapparatus.
•Theunitstartsbyexecutingtheself-test.
•AttheendoftheselftesttheunitenterstheHomemenuandisreadyforuse.
Note :
•StatUSTherapyisenabledautomaticallyonlyforES-7thatcomeswithStatUSapplicator.
•ForES-7hastobeconnectedtoStatUSforES-7inordertoperformStatUSTherapy.StatUSisa
feature(accessory)fortheapplicationofStatUSTherapy.GettheStatUSforES-7toperformStatUS
Therapy.
9. 2 Home menu
Thisdeviceisequippedwithtouchscreentechnology.
Via the menu you can access all functions.
Select the desired function by touching an icon.
9. 3 System settings
9.3.1 Set language
Touch the icon “System
Settings.” or “シス
”.
Select from the list
Language :
Touch the icon
“Language” or “言語” in
the list.
Touch ▲▼ icons to
select the language.
Touch “OK” to conrm
and to return to the
previous menu.
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9.3.2 Set brightness
Touch the icon
“Brightness.”
Touch ▲▼ icons to
adjust the brightness.
Touch “OK” to conrm
and to return to the
previous menu.
9.3.3 System info
Here you can nd all information about this device. Installed software is directly displayed on the
right side of the “system info” icon.
To view all other info’s, touch the “System info” icon. And you have all other information about
hardware on the screen.
Touch “BACK” icon in the screen to return to the previous menu.
9.3.4 Ultrasound norm
This device only oers one ultrasound standard, the EU standard. Nothing will be accepted if you
touch the “Ultrasound Standard” icon. An alarm will buzz.
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9. 4 Load clinical protocols
This device has 25 treatment
suggestions for the most
common treatments for
ultrasound.
Touch the icon “Clinical
Protocols” to activate the
list.
Select a protocol from the
list of treatment suggestion
or operate one of followings.
Touch [1] to display the
protocol information.
Touch ▲▼ icons to scroll
in the list.
The protocol information
screen shows the treatment
information and treatment
areas.
Touch ▲▼ icons to see
information on the
treatment area.
Touch “OK” icon to go to
the parameter screen.
The parameter screen
shows all parameters.
Touch [2] (intensity read-
out) to change the
intensity level.
Applicator and other
parameters are changeable
any time.
Adjust the intensity level
via the ▲▼ icon.
Touch “OK” icon to
return to the previous
menu.
Place the applicator on the
treatment area (with gel).
Contact control indicator
turns o and the treatment
time start (to countdown).
If there is an insucient
contact, the indicator will
light up and treatment
time will be interrupted.
D CAUTION :
The case examples and parameters which are pre-programmed in the treatment protocol
are set as representative cases in accordance with known treatment and literature. Before
starting the treatment, the therapist must check if the parameters are appropriate for each
patient and case. If necessary, change the parameters before starting the treatment.
1
2
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9. 5 Manual operation
9.5.1 Ultrasound frequency
Touch the action icon
“Manual Operation” to
activate this function.
Select a parameter in the
screen by touching the
icon.
Touch icon [3] to change
the frequency.
Select the frequency by
touching the icon.
1 MHz is deep
3 MHz is supercial
9.5.2 Continuous / pulsed mode
Touch the icon [4] to
select continuous or
pulsed mode.
Touch [A] or [B].
A is pulsed mode
B is continuous mode
If continuous pulse mode
is selected, no other
parameters (Frequency or
Duty Cycle) are available.
3
4
AB
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9.5.3 Pulse frequency
Touch the icon [5] to
select pulse frequency.
Touch the ▲▼ icon to
select pulse frequency.
There are 3 frequencies
available 16, 48 and 100 Hz.
Touch “OK” icon to return
to the previous menu.
9.5.4 Duty cycle
Touch the icon [6] to
select Duty Cycle.
Touch the ▲▼ icon to
select Duty Cycle.
There are 6 settings
available : 5, 10, 20, 33, 50
and 80 %.
Touch “OK” icon to
conrm and to return to
the previous menu.
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