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 CT-7 Product code
CT7-005
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.
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.
Table of Contents
1. Foreword ------------------------------------------------------------------------------------------------------ 4
1. 1 Intendeduser/operator ------------------------------------------------------------------------------------- 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 -------------------------------------------------------------------------------------------- 11
7.1.4 Duringtreatment -------------------------------------------------------------------------------------------- 11
7.1.5 After treatment ----------------------------------------------------------------------------------------------- 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 ------------------------------------------------------------------------------------------------14
8. 5 Manualoperation ---------------------------------------------------------------------------------------------16
8.5.1 Settingparameters:Frequencies ----------------------------------------------------------------------- 16
8.5.2 Selectingtheparameters:DutyCyclemodulationandAmplitudemodulation -------------- 17
8.5.3 Selectingtheparameters:Treatmenttime ------------------------------------------------------------ 17
8.5.4 Selectingtheparameters:Intensity--------------------------------------------------------------------- 18
8. 6 Favorites --------------------------------------------------------------------------------------------------------18
8.6.1 Storingprotocols -------------------------------------------------------------------------------------------- 18
8.6.2 Loadingfavorites -------------------------------------------------------------------------------------------- 19
8.6.3 Deletefavorites ---------------------------------------------------------------------------------------------- 19
9. Maintenance and Troubleshooting ----------------------------------------------------------------- 20
9. 1 Maintenancebytheuser -----------------------------------------------------------------------------------20
9.1.1 CleaningoftheStatUSapplicator ---------------------------------------------------------------------- 20
9.1.2 CleaningoftheStatUSsuctioncupandStatUSgelpadxationring -------------------------- 20
9.1.3 Cleaning of the cable--------------------------------------------------------------------------------------- 20
9. 2 Troubleshooting ----------------------------------------------------------------------------------------------- 21
9.2.1 Errorcode ----------------------------------------------------------------------------------------------------- 21
9.2.2 Optimizationofcontactcontrol -------------------------------------------------------------------------- 21
9.2.3 Technicalmaintenance ------------------------------------------------------------------------------------ 21
9. 3 Consumableparts -------------------------------------------------------------------------------------------- 21
10. Specications --------------------------------------------------------------------------------------------- 22
10. 1 Ultrasoundparameters--------------------------------------------------------------------------------------22
10. 2 Technicaldata -------------------------------------------------------------------------------------------------22
11. Warranty and Disclaimer ------------------------------------------------------------------------------- 23
12. Supplementary Information --------------------------------------------------------------------------- 24
13. Library -------------------------------------------------------------------------------------------------------- 25
4
1. Foreword
1. 1 Intended user / operator
ThismanualhasbeenwrittenfortheownersandoperatorsoftheStatUSforCT-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.Fordetailsonthe
installation and operation of the CT-7, refer to the CT-7 instruction manual.
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
About the StatUS for CT-7 (CT7-005)
Thisproductisafeature(accessory)fortheapplicationofStatUStherapyandworksonlywhen
connectedtoaPhysisystemCT-7device.
StatUSstandsforStationaryUltraSound:theapplicationofultrasoundwithoutmovingtheultrasound
treatmenthead(=stationary).
ElectrotherapyandStatUStherapycannotbeusedincombination.
StatUSforCT-7(CT7-005)isnotdesignedforuseincombinationwiththeVacuumUnitforCT-7
(CT7-001).
5
3. Precautionary Instructions
InthissectiongeneralWarningsandPrecautionsarelisted,thatyoushouldbeawareofwhenusingthe
StatUSforCT-7.Referto“4.IntendedUse”onPage6forwarningsandprecautionspertainingto
ultrasound therapy.
D WARNING:
•Thisdeviceshouldbeusedonlyunderthecontinuedsupervisionofaphysicianorlicensed
practitioner.
•Donotoperatetheunitinanenvironmentofshort-waveormicro-wavediathermyuseasthiscan
result in unstable or inaccurate output.
•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deviceshouldbekeptoutofthereachofchildren.
D CAUTION:
•Read,understandandpracticetheprecautionaryandoperatinginstructions.Knowthelimitationsand
hazardsassociatedwithusinganyelectricalstimulationdevice.
•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.
•Thisunitshouldbeoperatedintemperaturesbetween10and40°C,withrelativehumidityranging
from10to90%withoutcondensation.(SeePage22.)
•Donotexposetheunittodirectsunlight,heatradiatedfromaheatradiator,excessiveamountsof
dust,moisture,vibrationsandmechanicalshocks.
•TheStatUSforCT-7mustbeplacedbelowthePhysisystemCT-7device.
•HandletheStatUSapplicatorwithcaution.Improperhandingoftheapplicatormayadverselyaect
performance.
•Noattemptshouldbemadetodisassembletheunit.
ContactyourOGWellnessTechnologiesdistributortorequestservice.
•InspecttheStatUSapplicatorcablesandassociatedconnectorsbeforeeachuse.TheStatUS
applicatorandthecableshouldberegularlyinspectedfordamage,suchascracks,whichcould
causeuidtopenetrate.
•ToperformwelltheStatUSforCT-7shouldbecheckedthisonceayearbyaservicetechnician.
•DonotoperatetheStatUSforCT-7whenconnectedtoanyunitotherthanthePhysisystemCT-7
device.
•TheStatUSforCT-7shouldbeconnectedatthefront(connectorAorB)ofthePhysisystemCT-7
device.Amaximumofonechannelcanbeactive.YoucannotworksimultaneouslywithapplicatorA
and B.
•UseonlytheoriginalStatUSgelpads!
•TheStatUSgelpadsareintendedforonce-onlyuse.DonotuseliquidgelsuchasPhysisystemCT-7
ultrasoundgel,asthiswillbesuckedintothevacuumtubesandpump,causingmalfunction!
•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.
•Disposalofthisproductasgeneralwaste(householdwaste)maybeharmfultotheenvironment.
Alwaysusealicensedindustrialwastedisposalcompanyanddisposeofthedeviceasindustrial
wasteinaccordancewithlocallawsandregulations.Makesuretoretainacopyofthemanifestfrom
theindustrialwastedisposalcompany.
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
Painrelief,micromassageeectandreductionofmusclepainandjointpainresultingfromthermaland
non-thermalphysiologicalresponsetoultrasoundwaves.
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
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Page20.)
•OnlyapplytheStatUS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22.)
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time-
averaged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.
Ultrasoundcanbeappliedinpulsedorincontinuousmode.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)
D CAUTION:
Ingeneral,bothmodulationsarealwaysengaged(standardsetting)
andsynchronised(inphase)forthePhysisystemCT-7withStatUS
forCT-7.Thisensuresthegreatestpossibledierencebetweenthe
minimumandmaximumleveloftheeectiveoutput.
However,bothmodulationscanbeswitchedonandomanually.
Whenoneorbothmodulationsareswitchedo,thereisgreater
tendencyforcavitationandhotspots.Cautionisadvised.
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CT-7isafeature(accessory)fortheapplicationofStatUStherapyandonlyworks
whenconnectedtoaPhysisystemCT-7device.
TheStatUSforCT-7doesnothaveitsownpowersupplyandispoweredbythePhysisystemCT-7
device.Operatingthedeviceisalsodoneviathecontrolpanel(touchscreen)ofthePhysisystemCT-7
device.
Comment:theStatUSforCT-7isnotdesignedforuseincombinationwiththeVacuumUnitforCT-7
(CT7-001).
WhenusingtheStatUSapplicatorholder,rstremovetheapplicatorholderofthePhysisystemCT-7
device.
 PlacetheStatUSdevicebaseonatableorotheratandstablesurface.
Ensuresucientairowbeneaththedevice.(Donotplacethedeviceontablecloths,etc.)
PlacethePhysisystemCT-7deviceontopoftheStatUSdevicebase.
 Connecttheconnectorcabletothefront(connectorAorB)ofthePhysisystemCT-7device.
B
A
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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acousticsound.Whencontactrestorationissensedthetreatmentisresumedatthe
set amplitude.
Foroptimizationofcontactcontrol,see“9.2.2Optimizationofcontactcontrol”onPage21.
7.1.2 The contact medium
Toensureecienttransferofenergy,acontactmediumisrequiredbetweentheStatUSapplicator
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.
7.1.2.1 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CT-7ultrasoundgel,asthiswillbesuckedintothe
vacuumtubesandpump,causingmalfunction.
7.1.2.1.1 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.
11
7.1.2.1.2 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.
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patient’sskinorfromtheStatUSapplicator.
•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20.)
Todisinfect,wipewithaclothmoistenedwitha70%solutionofalcohol.
12
8. Operating Instructions
8. 1 Name of each part
StatUS (CT7-005)
LCD Touchscreen (CT-7)
Serial Number
Label
StatUS Applicator
Connector Cable
Fixation Ring
Gelpad StatUS
StatUS Applicator
Holder
StatUS Ultrasound
Contact Surface
StatUS Suction
Cup
Screen Header
Treatment Time
Duty Cycle
Suction Force
Duty Cycle
Modulation
Pulse Frequency
Amplitude
Modulation
Unit
Ultrasound
Frequency
Navigation Bar
Navigation Level
Channel Tab
13
LCD Touchscreen (CT-7): Navigation Bar
Button Description
Returntopreviousscreen
Returntohomemenu
Savetreatmentsettingsandtreatmentprograminfavorites
Deletefromlistoffavorites
Pausetreatment
Startorrestarttreatment
Conrmselecteditem
Emergency stop
LCD Touchscreen (CT-7): Channel Tab
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
Remaining
Treatment Time
Output Value UnitsOutput Value
Output Indicator
Output Status
14
8. 3 Basic operation
SwitchthePhysisystemCT-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CT-7
device.
8. 4 StatUS therapy
There are 50 pre-programmed treatment protocols.
Fromthehomemenu,select
“StatUSTherapy.”
Touchtheicon“ClinicalProtocols”
toactivatethelist.
Usethecentralregulatorto
scroll through the pages and
touch a button to select the
treatment protocol.
Touch for more therapy
information about the protocol.
Therapy information:
Usethecentralregulatortoscrollthroughthepages.Adescriptionisdisplayedfollowedbyimagesof
specicexamples.
Touch the icon(“accept”)tochangetotheparameterscreen.
Note:thenumbersunderLiteraturearereferringtorelevantpublicationslikeshownintheliteraturelist
(“13.Library”onPage25).
15
1
Thescreenshowsallparameters
in once glance.
•The parameters can be changed
at any time.
•Touch the button [1] to set
vacuumpressure.
PlacetheStatUSapplicatoron
the treatment area and increase
thevacuumpressureusingthe
central regulator.
Oncethereissucientcontact
the pause icon disappears
and treatment time starts counting
down.
Ifcontactisinsucient,itwillpause
thetreatmenttime.Inthiscase,
increasethevacuumpressure
until the contact is restored.
Oncethetreatmenttimehaselapsed,thevacuumpressurewill
stillbemaintainedfor1minutemax.ThispreventsthattheStatUS
applicatorimmediatelydisengagesattheendoftreatment(and
possiblydrops).Theswitch-otimeforthevacuumpressurecan
besetfrom1to10minutesinincrementsof1minute/canbe
changedviathe“sleepsettingafter…”buttoninthemenu
“Systemsettings”.Whenthesetswitch-otimehaselapsed,
post-treatmentsuctionturnsoandthescreengoesblank.
16
D CAUTION:
Ingeneral,theAmplitudeModulationandDutyCycleModulationarealwaysswitchedon(=standard
setting)*1.
However,bothmodulationscanbeswitchedonandomanually.(Seeimagesbelow.)
Whenoneorbothmodulationsareswitchedo,thereisgreatertendencyforcavitationandhotspots.
Cautionisadvised.
*1applieswhenusingthefunction"Manual".Insomeprotocols,themodulationsarenotactive.
Displayifbothmodulationsare
enabled(active).
DisplayifAmplitudeModulation
isdisabled(inactive).
DisplayifDutyCycleModulation
isdisabled(inactive).
8. 5 Manual operation
8.5.1 Setting parameters: Frequencies
2
Touchthe"ManualOperation"
button.
Selecttheparameterbytouching
therelevantbutton.
Example:Touchbutton[2]to
changethepulsefrequency.
Changethefrequencybyusing
the central regulator.
Theultrasoundfrequencycanbeset/adjustedinthesameway(1or3MHz).
17
8.5.2 Selecting the parameters: Duty Cycle modulation and
Amplitude modulation
WhenusingStatUStherapy,theDutyCycleModulation(aswellastheAmplitudeModulation)isalways
active.
Thismeansthat–ingeneral–thedeviceisalwaysinpulsedmodusandthattheDutyCycle(andthe
amplitude)varycontinuously.Becauseofthis,thebuttonforselectingthepulsemode[3]isnotaccessible.
3
4
Touch button [4] to change the
duty cycle.
•Thereare7options:100,80,
50,33,20,10and5%.
Selectthedutycyclewiththe
central regulator.
•Inthisexample,thedutycycle
dropsfrom20%to10,then
goesbackupto20%.
TheiconindicatesthattheDuty
Cycle modulation has been
switchedon(isactive).
8.5.3 Selecting the parameters: Treatment time
5
Touch button [5] to change the
treatment time.
Changetreatmenttimewiththe
central regulator.
18
8.5.4 Selecting the parameters: Intensity
6
Touch button [6] to change the
intensity.
Changetheintensitywiththe
central regulator.
Note:apop-upappearsifthe
selectedintensityexceedsthe
meanvalue.
•Touchthe button to
continueortoadjustthe
intensity.
8. 6 Favorites
Priortotheimplementationofanappropriateprotocoloramanuallysettreatmentsettingscanbesaved
as'favorites'.
8.6.1 Storing protocols
7
Firstsetthedesiredparameters.
Touch button [7] to store the
parameters.
Enter a name for the program
whenyousaveit.
Touch the button
(“conrm”).
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Enraf-Nonius STATUS User manual

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