Enraf-Nonius STATUS User manual

Type
User manual
Instruction manual
DBe sure to read this manual before use.
Keep this manual in a safe place for future reference.
StatUS™ for ES-7 Product code
ES7-002
For Professional Use
About the Instruction 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.
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zCompany names and product names described in this manual are trademarks or
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Table of Contents
1. Foreword ------------------------------------------------------------------------------------------------------ 4
1. 1 Thismanual ----------------------------------------------------------------------------------------------------- 4
1. 2 Productliability ------------------------------------------------------------------------------------------------- 4
2. Product description --------------------------------------------------------------------------------------- 4
3. Precautionary Instructions ------------------------------------------------------------------------------ 5
4. Intended Use ------------------------------------------------------------------------------------------------- 6
4. 1 Ultrasound ------------------------------------------------------------------------------------------------------- 6
4.1.1 Eect -------------------------------------------------------------------------------------------------------------6
4.1.2 Contraindications ----------------------------------------------------------------------------------------------6
4.1.3 Precautionsandwarnings ----------------------------------------------------------------------------------6
4.1.4 Associated risks -----------------------------------------------------------------------------------------------7
4.1.5 Potentialadverseeects ------------------------------------------------------------------------------------7
4.1.6 Parameters -----------------------------------------------------------------------------------------------------7
4. 2 StatUStherapy ------------------------------------------------------------------------------------------------- 7
4.2.1 Duty cycle modulation ---------------------------------------------------------------------------------------8
4.2.2 Amplitude modulation ---------------------------------------------------------------------------------------- 8
5. Package Contents ------------------------------------------------------------------------------------------ 9
5. 1 Standardaccessories ---------------------------------------------------------------------------------------- 9
5. 2 Optionalaccessories ----------------------------------------------------------------------------------------- 9
6. Installation ---------------------------------------------------------------------------------------------------- 9
7. Application Notes ---------------------------------------------------------------------------------------- 10
7. 1 Ultrasound ------------------------------------------------------------------------------------------------------10
7.1.1 Contact control ----------------------------------------------------------------------------------------------- 10
7.1.2 Thecontactmedium ---------------------------------------------------------------------------------------- 10
7.1.3 Before treatment -------------------------------------------------------------------------------------------- 10
7.1.4 During treatment -------------------------------------------------------------------------------------------- 10
7.1.5 After treatment ----------------------------------------------------------------------------------------------- 10
7. 2 StatUSapplicator ---------------------------------------------------------------------------------------------11
7.2.1 ApplyingtheStatUSgelpadxationring -------------------------------------------------------------- 11
7.2.2 ApplyingtheStatUSgelpad ------------------------------------------------------------------------------ 11
8. Operating Instructions ---------------------------------------------------------------------------------- 12
8. 1 Nameofeachpart -------------------------------------------------------------------------------------------12
8. 2 Descriptionofsymbols --------------------------------------------------------------------------------------13
8. 3 Basicoperation -----------------------------------------------------------------------------------------------14
8. 4 StatUStherapy ------------------------------------------------------------------------------------------------15
8. 5 ManualOperation --------------------------------------------------------------------------------------------17
8.5.1 Setting parameters : frequencies and units ---------------------------------------------------------- 17
8.5.2 Selecting the parameters : Duty Cycle modulation ------------------------------------------------- 17
8.5.3 Selectingtheparameters:Treatmenttime ----------------------------------------------------------- 18
8.5.4 Selecting the parameters : Intensity -------------------------------------------------------------------- 18
8. 6 Programs -------------------------------------------------------------------------------------------------------19
8.6.1 Storing protocols -------------------------------------------------------------------------------------------- 19
8.6.2 LoadingPrograms ------------------------------------------------------------------------------------------ 19
8.6.3 DeletePrograms -------------------------------------------------------------------------------------------- 20
9. Maintenance and Troubleshooting ----------------------------------------------------------------- 21
9. 1 Maintenancebytheuser -----------------------------------------------------------------------------------21
9.1.1 CleaningoftheStatUSapplicator ---------------------------------------------------------------------- 21
9. 2 Troubleshooting ----------------------------------------------------------------------------------------------- 22
9.2.1 Error code ----------------------------------------------------------------------------------------------------- 22
9. 3 Technicalmaintenance--------------------------------------------------------------------------------------22
9. 4 Consumableparts -------------------------------------------------------------------------------------------- 22
10. Specications --------------------------------------------------------------------------------------------- 23
10. 1 Ultrasoundparameters--------------------------------------------------------------------------------------23
10. 2 Technicaldata -------------------------------------------------------------------------------------------------23
11. Warranty and Disclaimer ------------------------------------------------------------------------------- 24
12. Supplementary Information --------------------------------------------------------------------------- 25
13. Library -------------------------------------------------------------------------------------------------------- 26
4
1. Foreword
1. 1 This manual
ThismanualhasbeenwrittenfortheownersandoperatorsoftheStatUSforES-7.Itcontainsgeneral
instructions on operation, precautionary practices, maintenance and parts information. In order to
maximizetheuse,eciencyandlifespanofyourunit,pleasereadthismanualthoroughlyandbecome
familiarwiththecontrolsaswellastheaccessoriesbeforeoperatingtheunit.
Thismedicalequipmentisintendedexclusivelyforusebyorunderthesupervisionofindividualswho
usetheequipmentaspartoftheirworkinthecontextofprofessionalhealthcare,whounderstandthe
benetsandlimitationsofelectroandultrasoundtherapy.Inotherwords,“professionalusers”.
1. 2 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its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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
OGWellnessTechnologiesorEnraf-Nonius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.
2. Product description
TheStatUSforES-7isafeature(accessory)fortheapplicationofStatUStherapyandworksonly
whenconnectedtoaES-7device.StatUSstandsforStationaryUltraSound:theapplicationof
ultrasoundwithoutmovingtheultrasoundtreatmenthead(=stationary).
5
3. Precautionary Instructions
InthissectiongeneralWarningsandPrecautionsarelisted,thatyoushouldbeawareofwhenusing
theStatUSforES-7.
D WARNING :
•Thisdeviceshouldbeusedonlyunderthecontinuedsupervisionofaphysicianorlicensed
practitioner.
•Thisdeviceshouldbekeptoutofthereachofchildren.
•Read, understand and practice the precautionary and operating instructions.
•Knowthelimitationsandhazardsassociatedwithusinganyelectricalstimulationdevice.
•Observetheprecautionaryandoperationaldecalsplacedontheunit.
Useofcontrolsoradjustmentsorperformanceofproceduresotherthanthosespeciedhereinmayresult
inhazardousexposuretoultrasonicenergy.
•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.
•Donotoperatetheunitinanenvironmentofshort-waveormicro-wavediathermyuseasthiscan
result in burns beneath the electrodes.
•Thisdeviceisnotsuitableforuseinthepresenceofammableanestheticsmixturewithair,oxygen,
ornitrousoxide.
D CAUTION :
•Thisunitshouldbeoperated,transportedandstoredintemperaturesasindicatedinsection10. 2
(technicaldata).
•Donotexposetheunittodirectsunlight,heatradiatedfromaheatradiator,excessiveamountsof
dust,moisture,vibrationsandmechanicalshocks.
•Theultrasoundtreatmenthead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.
•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.
•UseonlytheoriginalStatUSgelpads!DonotuseliquidgelsuchasPhysisystemES-7ultrasoundgel,
asthiswillbesuckedintothevacuumtubesandpump,causingmalfunction!Anywarrantyclaimwill
berejectedifliquidgelresidueiffoundinanyofthesecomponents.
•InthecaseofingressofliquidsintotheStatUSapplicatororcable,turnthepowero,unplugtheunit
fromthemainssupplyandcontactyourOGWellnessTechnologiesdistributor.
•Thegelpadsareintendedforonce-onlyuse.
•DonotoperatetheStatUSforES-7whenconnectedtoanyunitotherthanthePhysisystemES-7
device.
•TheStatUSapplicator/StatUSforES-7shouldbeconnectedtotherightside(connectionB)only.
•Amaximumofonechannelcanbeactive.YoucannotworksimultaneouslywithapplicatorAandB.
•TheStatUSforES-7mustbemountedontheES-7deviceinsuchawaythatthemountingholesare
coveredatalltimes.
•DonotremovetheStatUSforES-7onceithasbeenmountedontheES-7.Thematerialsare
designed for one-time assembly.
•InspecttheStatUSapplicatorcablesandassociatedconnectorsbeforeeachuse.
•ToperformwelltheStatUSforES-7shouldbecheckedthisonceayearbyaservicetechnician.
•Noattemptshouldbemadetodisassembletheunit.Maintenanceandrepairshouldbecarriedoutby
authorizedpersonnelonly.OGWellnessTechnologiesandEnraf-Noniuswillnotbeheldresponsible
fortheresultsofmaintenanceorrepairsbyunauthorizedpersons.
•Findoutwhatthelocalregulationsforwastemanagementarebeforedisposingoftheunit.
6
4. Intended Use
4. 1 Ultrasound
Ultrasoundisamechanicalenergyconsistingofhigh-frequencyvibrationsappliedbymeansofan
ultrasoundtreatmenthead.Thesevibrationspassthroughthetissueofthebodyandaregradually
absorbedandtransformedintoheat.Theresultingtemperatureincreasetriggersbiologicalchangesto
occurinthetissueforthereliefofpain,relaxationofmusclespasmsandreductionofjoint
contractures.
4.1.1 Eect
Ultrasoundisindicatedforconditionsthatbenetfromtheapplicationofdeepheat:reliefofpain,
musclespasmsandjointcontractures.Theobjectiveoftherapeuticultrasoundinthetreatmentof
selectedmedicalconditionsassociatedwiththechronicandsubchronicconditionsofbursitis/
capsulitis, epicondylitis, ligament sprains, tendinitis, scar tissue healing and muscle strain is to reduce
pain.
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tothedevelopingfetus.
•Ultrasoundshouldnotbeusedonunconsciouspatients.
•Theheart.
•Thebrains.
•Thetesticles.
•Theeyes.
*=DoesnotapplytoLIPUS(LowIntensityPulsedUltrasound)
4.1.3 Precautions and warnings
•Precautionshouldbetakenwhenusingtherapeuticultrasoundonpatientswithhemorrhagicdiatheses.
•Ultrasoundtreatmentpresentsapotentialsafetyhazardinpatientswhosepainresponsehasbeen
decreasedbecauseofdisease,previoussurgery,ionizingradiationtherapy,chemotherapy,orgeneral
orregionalanesthesia.Itmaycauseburns.Donotuseoninsensitiveareasorinthepresenceofpoor
circulation.
•Largethermaldosesmayresultinregionsofthermalasepticnecrosiswhichmaynotbeapparenton
inspection of the skin.
•SincetheStatUSapplicator/ultrasoundtreatmentheadtransfersultrasoundenergyintothetissueat
amostecientandeectiveway,weadviseyoutouselowerintensitysettingsthantheusual
intensitysettingsfor'traditional'(semi-stationaryordynamic)ultrasound.
•Alwaysensureproperhygiene(see9.1Maintenancebytheuser).
•Onlyapplytheultrasoundtreatmentheadonintactskin.Whentreatingdamagedskin(forexample
ulcers),onlyplacethetreatmentheadontheedgesofthewound,neveronthewounditself.
•Seealso“3.PrecautionaryInstructions”onPage5,forgeneralWarningsandPrecautions.
7
4.1.4 Associated risks
•Useofultrasoundintreatingareasabovetheshouldersmayposerelevanthazards.
Whileitisrecognizedthatcertainspecicconditionsinvolvingtheeyescanandhavebeentreatedby
specialistsqualiedbytraining,knowledgeandexperiencetoadministersuchtreatments,such
applicationcarrieswithitrecognizedhazardsofapplyingheattotheeyes.
•Treatmentofthethyroid,aswellaslymphnodesintheneck,mayexposethepatienttoasyet
undeterminedeectsinasmuchasthesafetyofsuchtreatmentshasnotyetbeenestablished.
4.1.5 Potential adverse eects
•Cataracts
•Malesterility
•Enhanceddrugactivity
•Thermalstress
4.1.6 Parameters
UltrasoundFrequency,expressedinMHz
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,expressedin%
Denestheratioofthepulsedurationtothepulserepetitiontime.Ultrasoundcanbeappliedinpulsedor
incontinuousmode.WhentheDutyCycleissetto100%,theapparatusoperatesincontinuousmode.
EectiveRadiationArea(ERA)expressedincm2
Denesthecross-sectionalareaoftheultrasoundbeam.(SeePage23.)
TheEectiveRadiationAreaisxedanddenedbythesizeoftheultrasoundapplicator.
UltrasoundPower,expressedinW
Theultrasoundoutput.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,expressedinW/cm2
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
timeaveragedAmplitudecanbeobtainedbymultiplyingthisvaluewiththeDutyCycle.
4. 2 StatUS therapy
StatUSstandsforStationaryUltraSound:theapplicationofultrasoundwithoutmovingtheStatUS
ultrasoundtreatmenthead(=stationary).
Inthenormalcourseofevents,ultrasoundenergyisadministeredbymoving(‘makingcircles’)the
treatmenthead.Thismovingofthetreatmenthead(alsocalledthedynamicorsemi-stationarymethod)
isessentialbecauseafewunfavourablephenomenaoccurbothwithinanultra-soundbundleaswell
asinthetissue,whichmayleadtotissue,damage(so-called‘hotspots’).
StatUS-therapy,ontheotherhand,makesuseoftwospecialformsofmodulationthatensurethatthe
peaksinintensityintheultra-soundbundlearestronglyreduced,diminishingtheriskofcavitationand
preventingtheoccurrenceof‘hotspots’.
Thesemodulationformsare:
1.DutyCycleModulation
2.AmplitudeModulation
8
4.2.1 Duty cycle modulation
Dutycyclecanbedescribedastheproportionbetweenthedurationofthepulseandthedurationof
theinterval.Thedutycycleisexpressedinapercentage(%).Thedeviceisworkinginacontinuous
moduswhenthedutycycleis100%.
Dutycyclemodulationimpliesthatthedutycycleuctuatesautomaticallyinaowingpattern.The
modulationischaracterisedbyaxeddurationofatotalof12seconds,duringwhichtimethe(pre)set
dutycyclegoesto5%andbackagain.So,ifthedutycycleissetat50%,thenitwillgraduallydropto
5%in6secondsandthenincreaseagainfrom5%to50%in6secondsaswell.Andsothe
modulation actually ensures that the pulse duration is automatically reduced or increased.
DutyCycleModulation(exampleofthemodulationwhenDutyCycleissetat50%).
4.2.2 Amplitude modulation
AmplitudeModulationinvolvesvaryingtheultra-soundintensity.Thisformofmodulationisalso
characterisedbyarhythmicperiodof12seconds.Theintensity(W/cm2)issetat100%.Theintensity
willgraduallydropfrom100%to85%intherst6seconds,afterwhichitwillincreasebackupto
100%inthenext6seconds.
AmplitudeModulation(exampleofthemodulationwhenintensityissetat1.0W/cm2).
BothmodulationsoftheES-7withStatUSforES-7arealwaysswitchedon*andsynchronous(in
phase).Thisensuresthegreatestdierencebetweentheminimumandmaximumleveloftheeective
capacity.
*Appliestotheuseofthe“ManualOperation”function.Inafewoftheprotocolsthemodulationsare
notactive.
9
5. Package Contents
5. 1 Standard accessories
CT7-006 GelpadStatUS(240x)
CT7-007 FixationringgelpadStatUS(3x)
Instructionmanual(thismanual)
Instructionmanual(Japaneseversion)
5. 2 Optional accessories
CT7-006 GelpadStatUS(240x)
CT7-007 FixationringgelpadStatUS(3x)
6. Installation
TheStatUSforES-7isafeature(accessory)fortheapplicationofStatUStherapyandonlyworks
whenconnectedtoaPhysisystemES-7device.
TheStatUSforES-7doesnothaveitsownpowersupplyandispoweredbythePhysisystemES-7
device.Operatingthedeviceisalsodoneviathecontrolpanel(touchscreen)ofthePhysisystemES-7
device.
[A] Connection for (traditional) ultrasound treatment head (left side)
[B] Connection for StatUS applicator (right side)
D CAUTION :
•TheStatUSapplicator/StatUSforES-7shouldbeconnectedtotherightside(connectionB)only.
•TheStatUSforES-7mustbemountedontheES-7deviceinsuchawaythatthemountingholesare
coveredatalltimes.
•DonotremovetheStatUSforES-7onceithasbeenmountedontheES-7.Thematerialsare
designed for one-time assembly.
•TheStatUSapplicator/ultrasoundtreatmentheadisaprecisioninstrument.Eectivepoolingof
propertieswasanimportantfocusduringdevelopmentandproduction.Carelesshandling(jarringor
dropping)mayhaveanegativeeectonthesepropertiesandshouldthereforebeavoided.
•Amaximumofonechannelcanbeactive.YoucannotworksimultaneouslywithapplicatorAandB.
B
A
10
7. Application Notes
7. 1 Ultrasound
7.1.1 Contact control
TheStatUSapplicatorhasacontactcontrolfunctionthatsuspendstreatmentwhentheacoustical
contactwiththebodydropsbelowacertainlevel.Thedisplaywillshowthesymbol“Pause”(▌▌)and
youwillhearanaccousticsound.Whencontactrestorationissensedthetreatmentisresumedatthe
set amplitude.
7.1.2 The contact medium
Toensureecienttransferofenergy,acontactmediumisrequiredbetweentheultrasoundtreatment
headandthebody.Aircausesvirtuallytotalreectionoftheultrasoundenergy.Agelpadshouldbe
usedtotransferultrasoundenergyviatheStatUSapplicator.
7.1.3 Before treatment
•Checkthepatientforcontraindications.(SeePage6.)
•Testthewarmthsensibilityofthetreatmentarea.
•Tooptimizeultrasoundtransmission,cleantheskinofthetreatmentareawithsoapora70%solution
of alcohol.
•Stronghairgrowthhastobeshaved.
7.1.4 During treatment
•Duringtreatmentthedisplayedultrasoundamplitudecanvaryaroundthesetvalue,causedby
uctuationsinacousticalcoupling.
•Askthepatientregularlyforhis/herndings.Ifnecessarythetreatmentwillhavetobeadapted.The
amplitude can be reduced.
7.1.5 After treatment
•PeelthegelpadfromthepatientʼsskinorfromtheStatUSapplicator.
•Cleantheskinofthepatientandtheultrasoundtreatmentheadwithatowelortissue.
•Checkfortheeectsthatcanbeexpected(forexamplepain,circulationandmobility).
•Ask the patient to inform the therapist of any reactions.
•CleantheStatUSapplicatortreatmenthead.(SeePage21.)
Todisinfect,wipewithaclothmoistenedwitha70%solutionofalcohol.
11
7. 2 StatUS applicator
AspecialStatUSgelpadisplacedontheStatUSapplicatortreatmentheadforapropertransferofthe
ultra-soundenergy.ThegelpadisheldinpositionusingaStatUSxationring.Thevacuumpressure
ensures that the head can be placed on the body quickly and easily and that the head remains in
contactwiththebodysurface.
D NOTICE :
•DonotuseliquidgelsuchasPhysisystemES-7ultrasoundgel,asthiswillbesuckedintothevacuum
tubesandpump,causingmalfunction!
7.2.1 Applying the StatUS gelpad xation ring
GentlypushouttheStatUSultrasoundcontactsurfaceoftheStatUSapplicator.
Installthexationringonthecontactsurface.
7.2.2 Applying the StatUS gelpad
Gelpadsaremadefromnaturalmaterialsandaresubjecttodiscoloring.Discoloringdoesnotaectthe
functioningofthegelpad.Storegelpadsinacool,darkanddryplace.Expirationdateisindicatedon
theouterbox;checktheexpirationdatepriortouse.
D WARNING :
•Gelpadsareforexternaluse.
•Gelpadsarenotsterilized.Donotuseonwounds,etc.
•Thegelpadsareintendedforonce-onlyuse.
•Alimitedamountofsmallairbubblesdoesnoteecttheproperfunctioningoftheproduct.
 PlaceagelpadintheStatUSringttedontheStatUSultrasoundcontactsurface.
12
8. Operating Instructions
8. 1 Name of each part
StatUS (ES7-002)
LCD Touchscreen (ES-7)
Serial Number
Label StatUS Applicator
Connector Cable
Fixation Ring
Gelpad StatUS
StatUS Applicator
Holder
StatUS Ultrasound
Contact Surface
StatUS Suction
Cup
Treatment Time
Duty Cycle
Vacuum Pressure
Frequency
Save
PulseMode
(not accessible for
StatUStreatment)
Intensity
13
8. 2 Description of symbols
Refer to instruction Catalogue number Serial number Date of manufacture
Manufacturer Type B applied parts Waste Electrical and
Electronic Equipment
14
8. 3 Basic operation
SwitchthePhysisystemES-7on.
Insertthepowercordintothepowerconnector,andplugitintothepoweroutlet.
Turnthemainpowerswitchon.
Pushthepowerbuttontostartthedevice.
After running a self-test, the home menu is displayed.
OperationofStatUStreatmentisdoneviathecontrolpanel(touchscreen)ofthePhysisystemES-7
device.
Note:
Theavailabletherapychoicesmayvarybymodelandaredependingontheaccessoriesconnectedto
terminalAand/orB.IfonlyaStatUSforES-7isconnected(connectionB),thenonlythetherapy
choice“StatUSTherapy”isaccessible.Thetherapychoice'UltrasoundTherapy”isgrayedandthe
functionisnotactive(seeillustrationabove).Onceamulti-frequencytreatmentheadonchannelAis
connected,thefunction'UltrasoundTherapy'isclearlyvisibleandaccessible.
SelectStatUStherapyfromthemainmenu.
Thenyoucanchoosefrom“ClinicalProtocols”,“Programs”and“ManualOperation”.
-Under“ClinicalProtocols”youcanretrievethe50pre-programmedtreatmentprotocols.
-Underthepersonalprotocols“Programs”youcanretrieveyourstoredprotocols.
-Undermanualsettings“ManualOperation”,youcansetalltheparameters.
15
8. 4 StatUS therapy
Thereare50pre-programmedtreatmentprotocols.
•Touchtheicon“Clinical
Protocols”toactivatethelist.
Select in the list the treatment
suggestion or :
•Touchtheicon for more
therapy information about the
protocol.
•Touchthe▲▼icontoscrollin
the list.
Note:Thenumbersunder
Literature are referring to
relevantepublicationslikeshown
intheliteraturelist(“13.Library”
onPage26.)
Theblocks(see[1])indicate
whereyouareinthelist.
Conrmtheselectionwiththe
“OK”button.
Thescreenshowsallparameters
in once glance.
•Theparameterscanbechanged
all time.
•Touchthebutton[2]toset
vacuumpressure.
1
2
16
•PlacetheStatUSapplicatoron
the treatment area and
increasethevacuumpressure
usingthe▲▼buttons.
•Oncethereissucientcontact
the pause icon disappears and
treatment time starts counting
down.
•Conrmtheselectionwiththe
“OK”button.
•Ifcontactisinsucient,itwill
pause the treatment time.
•In this case, increase the
vacuumpressureuntilthe
contact is restored.
•Asmallcube,which
rhythmically increases and
decreases, indicates that the
modulationsareactive.
Oncethetreatmenttimehaselapsed,thevacuumpressurewillstillbemaintainedfor2minutes.This
preventsthattheStatUSapplicatorimmediatelydisengagesattheendoftreatment(andpossibly
drops).Beforethevacuumpressuredenitelycloses,therewillbeanaudiblebeepinthelast15
seconds.
17
8. 5 Manual Operation
8.5.1 Setting parameters : frequencies and units
•Touchthe“ManualOperation”
button.
•Select the parameter by
pressingtherelevantbutton.
•Example:Touchbutton[3]to
change the frequency.
•Usethe▲▼buttonstochange
the frequency.
•Conrmtheselectionwiththe
“OK”button.
8.5.2 Selecting the parameters : Duty Cycle modulation
WhenusingStatUStherapy,theDutyCycleModulation(aswellastheAmplitudeModulation)isalways
active(see4.2).Thismeansthatthedevicealwaysoperatesinpulsationmodewithcontinuousvariation
oftheDutyCycle.Becauseofthis,thebuttonforselectingthepulsemode[4]isnotaccessibleandis
greyed out.
•Touchthebutton[5]tochange
the duty cycle.
Usethe▲▼buttonstoselect
the duty cycle.
•Thereare6options:100,80,
50,33,20,10%.
•Conrmtheselectionwiththe
“OK”button.Thiswillautomatically
takeyoubacktotheprevious
screen.
Inthisexample,thedutycycle
dropsfrom10%to5%,then
goesbackupto10%.
A rhythmically increasing and
decreasing cube indicates that
themodulationsareactive.
3
4
5
18
8.5.3 Selecting the parameters : Treatment time
•Touchthebutton[6]tochange
the treatment time.
•Changetreatmenttimewiththe
▲▼buttons.
•Conrmtheselectionwiththe
“OK”button.
Youwillautomaticallyreturnto
thepreviousscreen.
8.5.4 Selecting the parameters : Intensity
•Touchthebutton[7]tochange
the intensity.
Usethe▲▼buttonstochange
the intensity.
•Conrmtheselectionwiththe
“OK”button.Thiswillautomatically
takeyoubacktotheprevious
screen.
Note:Apop-upappearsifthe
selectedintensityexceedsthe
meanvalue.
•Touchthe“Proceed”tokeep
goingortoadjusttheintensity.
7
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Enraf-Nonius STATUS User manual

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