Hitachi EUP-VV531 User manual



0123












TransvaginalProbe



EUP‐VV531



INSTRUCTIONMANUAL






Notesforoperatorsandresponsiblemaintenancepersonnel
★PleasereadthroughthisInstructionManualcarefullypriortouse.
★KeepthisInstructionManualtogetherwiththesystemwithcareto
makeitavailableanytime.







Tokyo,Japan
Q1E‐EP1028‐5

©Hitachi,Ltd.2013,2017.Allrightsreserved.



(1)Q1E‐EP1028


Manufacturer:

Hitachi,Ltd.
2‐16‐1,Higashi‐Ueno,Taito‐ku,Tokyo,110‐0015,Japan
+81‐3‐6284‐3668
http://www.hitachi.com/businesses/healthcare/index.html

European
Representative:



HitachiMedicalSystemsGmbH
Otto‐von‐Guericke‐Ring3D‐65205Wiesbaden,Germany

EUImporter:HitachiMedicalSystemsEuropeHoldingAG
Address:Sumpfstrasse13CH‐6300Zug,Switzerland

LocalDistributor:


(2)Q1E‐EP1028

Aboutthismanual
Thisinstructionmanualshallprovideinstructionsforusing,cleaning,anddisinfectingthe
HITACHIultrasoundprobes.Italsodescribessafetyconsiderations,maintenance.
Forinstructionsforoperatingthemainunit,refertotheoperationmanualforit.
Beforeusingtheprobe,thoroughlyreadthismanualandkeepthisbookforfuture
reference.
Ifyouhaveanyquestionsconcerningthemanual,pleasecontactaservicesupport.
Thefollowingconventionsareusedthroughoutthemanualtodenoteinformationof
specialemphasis.
WARNING:“Warning”isusedtoindicatethepresenceofahazardwhichcancause
severepersonalinjury,death,orsubstantialpropertydamageifthewarning
isignored.
CAUTION:“Caution”isusedtoindicatethepresenceofahazardwhichwillorcan
causeminorpersonalinjuryorpropertydamageifthecautionisignored.
NOTICE:“Notice”isusedtonotifypeopleofinstallation,operation,ormaintenance
informationwhichisimportant,butnothazardrelated.



(3)Q1E‐EP1028

GraphicalSymbolsforUseinLabelingofHitachiUltrasoundProbes
SomegraphicalsymbolsthatareusedinlabelingofHitachiUltrasoundProbesare
compliantwithEN980:2008standard.Refertothefollowingtableaboutthemeaningsof
them.
ExplanationofSymbol SymbolDescriptiveContent
Manufacturer
CompanyNameand
Address
Hitachi,Ltd
2‐16‐1,Higashi‐Ueno,taito‐ku,
Tokyo,110‐0015,Japan
Authorized
RepresentativeinThe
EuropeanCommunity
HitachiMedicalSystemsGmbH
Otto‐von‐Guericke‐Ring3D‐65205Wiesbaden,
Germany

Keepawayfrom
Sunlight
Storetheprobeinacool,dustproofanddark,dry
environmenttoavoidhightemperatureand
humidityanddirectsunlight.



(4)Q1E‐EP1028

Definitionofsymbol
ThefollowingsymbolisalsousedforHITACHIUltrasoundProbes.
LocationSymbolDefinition
Probe
connector
ThisinstrumentcomplieswithDirective93/42/EECrelatingto
MedicalDeviceandDirective2011/65/EUrelatingtoRoHS
Probe
connectorIPX7IPX7mark Seesection1.5.
Probe
connectorTypeBFAPPLIEDPART
Probe
connectorGeneralwarningsign
Probe
connectorWarning;dangerousvoltage
Probe
connectorCaution;Biohazard
Probe
connector
Followtheinstructionmanualtooperatethisinstrument.Ifnot
avoided,mayresultininjury,propertydamage,ortheequipment
trouble.
Probe
connector
Donotwastetheinstrumentasgeneralwaste.Complywitha
localregulation.
Probe
connectorRxOnly Byprescriptiononly.U.S.FederalLawrestrictsthisdevicetosale onorderofaphysicianonly.



(5)Q1E‐EP1028


CONTENTSPage
1. Introduction∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙1
1.1 Features∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙1
1.2 Principlesofoperation∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙1
1.3 IntendedUse∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙1
1.4 Composition∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙1
1.5 Construction∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙2
2. InspectionbeforeUse∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙2
2.1 InspectionforAppropriateConnection∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙2
2.2 InspectionforMaterialSurface∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙2
3. OperationProcedure∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙3
4. CleaningandDisinfection∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙4
4.1 Pointofuse(Pre‐cleaning)∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙5
4.2 Containmentandtransportation∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙5
4.3 ManualCleaninganddisinfection∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙6
4.4 Drying∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙7
4.5 Inspection∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙7
5. MaintenanceandSafetyInspection∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙8
5.1 Dailycheck∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙8
6. SafetyPrecautions∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙9
7. Specifications∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙10
7.1 Probe∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙10
7.2 SuppliersList∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙11
8. Disposaloftheprobe∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙11



‐1‐ Q1E‐EP1028

CAUTION
1. Introduction
1.1 Features
TheprobeofModelEUP‐VV531isaconvexarraytype.
Theacousticoutputofthisprobewhenconnectedtoultrasoundscannerwasmeasured
accordingtotheIEC60601‐2‐37standard.Thetableofmeasuredacousticoutputdatais
containedintheoperationmanualofeachultrasoundscanner.
ThisprobeiscategorizedinclassIIaaccordingtoDirective93/42/EEC.
AccordingtoIEC60601‐1theprobeisclassifiedastypeBF.
1.2 Principlesofoperation
Thisprobeandtheultrasounddiagnosticscannerenableimagediagnosisusingultrasonic
waves.Thissystemoperatesundertheprinciplesdescribedbelow.
1) Whenanelectricpulsesignalisappliedfromthetransmittertothetransducerofthe
probe,thetransducerconvertselectricsignalsintomechanicalvibrationenergyfor
emittingpulse‐shapedultrasonicwavesintothebodypart,liquidorothermedium
contactingthetransducer.
2) Theemittedultrasonicwavesarereflectedbyboundarieswithdifferentacoustic
characteristics(acousticimpedance)withinthebody.
3) Thetransducerisalsousedtoreceivereflectedultrasonicwaves.Thetransducer
vibratesmechanicallyduetothereceivedultrasonicwavesandconvertsmechanical
vibrationsintoelectricenergy.Electricsignalsareconvertedtoshadesofbrightnessby
brightnessmodulationtoobtainanimage.

1.3 IntendedUse
TheTransvaginalProbeEUP‐VV531isdesignedforobservationanddiagnosismainlyof
thefollowingregionsbyconnectingwiththeHITACHIultrasoundscanner.
Transvaginal
Transrectal

1.4 Composition
TheprobecomponentsoftheEUP‐VV531areasfollows:
1) ProbeEUP‐VV531∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1piece
2) InstructionManual∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1copy


Disinfectionhasnotbeenmadetotheprobeshippedfromthefactory.Priortouseofit,
besuretocleananddisinfectit.


‐2‐ Q1E‐EP1028

1.5 Construction


2. InspectionbeforeUse
Priortouse,theprobemustbecarefullyinspectedthatitisappropriateforuse.Ifnot,do
notusetheprobeandimmediatelycontactaservicesupport.
2.1 InspectionforAppropriateConnection
1) Checkthatthesystemiscorrectlyoperating.Refertotheinstructionmanualforthe
Mainunit.
2) Neverattachorconnectunauthorizeddevicesorinstrumentsontheprobe,suchas
unauthorizedbiopsyattachments.

2.2 InspectionforMaterialSurface
Visuallycheckthesurfaceoftheprobehead,housingandcableforanycrack,scratchor
denaturalization.
Cable
Immersiblepart:
Thispartcanbeimmersedindisinfectant
solutionandalsocanbecleanedbywater.
Un‐immersiblepart:
Thispartshouldnotbeimmersedindisinfectant
solutionandalsocannotbecleanedbywater.
Connector
Immersiblepart(IPX7)
Fig.1External View
Un‐Immersiblepart
Appliedpart
Head


‐3‐ Q1E‐EP1028

3. OperationProcedure
1) Confirmthattheprobeisdisinfected.
2) Connecttheprobe,operatetheMainunit,and
adjusttheimageaccordingtotheinstructions
givenintheoperationmanualforthemainunit.
3) Relationshipbetweendirectionoftheprobeand
theright‐leftorientationmarkontheimageis
showninFig.2.
4) Beforeadiagnosis,putaprobecovertothetipof
theprobecertainly.Beforeputtingaprobecover,
putsterilizedacousticjellytothetipoftheprobe
andattachaprobecovertothetipoftheprobe
closely.Somelatexmaterialmaycreateallergic
reaction.Pleaseuseallergyfreematerialcovers.
5) Aftertheuseoftheprobe,itshouldbecleanedand
disinfected,thenstoreitinanadequateplace.











Fig.2Relationshipbetween
directionoftheprobeand
Right‐leftOrientationMark
Right‐left
orientation
mark


‐4‐ Q1E‐EP1028

4. CleaningandDisinfection

Theprobeandaccessorymustbereprocessedaftereachuse.Refertothe
reprocessinginstructioninthischapter.
WARNINGS
‐Theprobeisdeliveredunsterile.Priortothefirstuse,reprocessthe
probe.
‐Temperatureshouldnotexceed50°Cduringreprocessing.
‐Probeconnectorisnotwaterresistant.
Limitationson
reprocessing
Theprobeisnotcompletelysubmersible.Theimmersiblepartis
showninFig.1Theun‐immersiblepartshouldbedisinfectedbywipe
disinfection.
Sterilizationisnotpossibleforthisprobe.
Transportation
beforeusing
Theprobeshouldbepackedinasterilepouchorcontainertotransport
fromCentralSterileSupplyDepartment(CSSD)toanoperatingroom.
Becarefulnottodamagethesterilepouchorcontainerduring
transportation.
Levelsofreprocessingrequirements:
Dependingontheapplicationoftheproductandwithregardtoriskevaluation,theuser
hastoclassifythemedicaldeviceaccordingtothecurrentMedicalDeviceDirectivefor
processingofmedicaldevicesasuncritical,semi‐criticalorcritical.Supportinginformation
concerningthistopicislistedinthetablebelow.Theuserisresponsibleforcorrect
classificationofthemedicaldevice.
ClassificationDefinitionProcessing
uncriticalApplicationpartonlycontactsintact
anduninjuredskin
Cleaning
Disinfection
semicriticalApplicationpartcontactsmucosa
(intracavitaryapplication)
Cleaning
Disinfection(Disinfectantwith
virucidaleffect)
critical
Applicationpartcontacts
intracorporealtissuedirectly
(operativeapplication)
Cleaning
Disinfection(Disinfectantwith
virucidaleffect‐minimum)
Sterilization
Accordingtotheintendeduse,EUP‐VV531probeisclassifiedassemicritical.



‐5‐ Q1E‐EP1028

Theflowchartofthereprocessingprocessofthisprobeisasfollows.


4.1 Pointofuse(Pre‐cleaning)
Pre‐cleaningshouldbedoneimmediatelyaftereachuse.Theprocedureisasfollows:
1) Removetheprotectivecover.
2) Cleantheprobeofallpatient’sbloodorfluidwithrunningtapwateruntilthesurface
oftheprobelooksvisuallyclean.
3) Wipethewholesurfaceoftheprobewithgauzepadandremovesuperficialvisible
impurities.

4.2 Containmentandtransportation
Puttingthecontaminatedequipmentintoexclusiveshockanddamageproofcontainerfor
transportationisrecommended.Itisrecommendedthatinstrumentsarereprocessedas
soonaspossibleandnotlaterthan4hoursafterusage.
Pointofuse
(Pre‐cleaning)
ManualCleaning
Rinsingaftermanual
cleaning
ManualDisinfection
Drying
Manualcleaningand
disinfection
Rinsingaftermanual
disinfection
Containmentand
transportation
Pointofuse
(Pre‐cleaning)
Containmentand
transportation


‐6‐ Q1E‐EP1028

4.3 ManualCleaninganddisinfection
Preparefollowingitemsbeforemanualcleaninganddisinfection:
a) Detergent:Cidezyme(Johnson&Johnson,#2258)oranothercleaningagentwith
approvedmaterialcompatibilityforthismedicaldevice
b) Disinfectant:CidexOPA(Johnson&Johnson,#20391)oranotherdisinfectantwith
approvedmaterialcompatibilityforthismedicaldevice
c) Twotanks,oneforcleaningandonefordisinfection‐optional:
1additionaltankforrinsingwithdeionized/tapwater(sufficientsizeforimmersionof
theimmersiblepartoftheprobeatfulllength)
d) Soft,flufffreeclothorsingleusetowel
e) Personalprotectiveequipment(gloves,waterrepellentprotectiveskirt,faceprotection
maskorprotectiveglasses,seealsoinstructionsofthemanufacturerforthedetergent
andthedisinfectant)

ManualCleaning:
Preparethedetergentsolutioninatankwithcoldwater(pleasefollowtheinstructionsof
thedetergentmanufacturerregardingapplication,dilutionandcontacttime).
1) Thetemperatureofthedetergentsolutionshouldbebetween15‐30°C,concentrationis
1.6%.Pleasenotetheminimumcontacttimeofthedetergentinthemanufacturer’s
instruction.Ifadifferingdetergentisused,pleasealsonotetheapprovedmaterial
compatibilityforthemedicaldevice.
2) Immersetheimmersiblepartoftheprobewithoutconnector
intothediluteddetergentsolution(seeFig.3).Wipethe
immersiblepartoftheprobeunderthesurfaceofthedetergent
solutionwithasoftclothtoremoveallvisiblesoil.Besurethat
allgroovesoftheprobeareimplementedduringthecleaning
process.
3) Theimmersiblepartoftheprobeshouldbeleftinthe
detergentsolutionaccordingtothespecifiedcontacttimeof
thedetergentmanufacturer.
4) Wipetheun‐immersiblepartsoftheprobewithasoftcloth
dippedwiththedetergentsolution.
5) Rinsetheprobewithrunningtapwaterfor1minute.
(alternatively:immersetheimmersiblepartoftheprobeina
trayfilledwithdeionizedwater/tapwater(seeFig.3)for5
min.)
6) Visuallychecktheoutersurfaceoftheprobeforcleanness.If
necessary,usemagnifyingglassforvisuallycheck.Ifthereis
stillsoilvisible,repeatallabovesteps.
Fig.3Immersion
oftheprobe
Water,Detergent
orDisinfectant


‐7‐ Q1E‐EP1028

WARNING
Manualdisinfection:
1) Preparethedisinfectantsolutioninatankwithcoldwater(pleasefollowthe
instructionsofthedisinfectantmanufacturerregardingapplication,concentration,
microbiologicalefficiency,servicelifeandcontacttime).
2) Confirmtheconcentrationofthedisinfectantbeforeimmersingtheprobe.Although
Cidex®OPAdoesnotneedtobediluted,itisrecommendedtouseteststripstoverify
theconcentration.Theteststripscanindicatewhetherornottheconcentrationis
abovetheMinimumEffectiveConcentration(MEC).Pleasealsonotetheexpiration
dateoftheteststripes.Temperatureofdisinfectantsolutionshouldbeminimum20°C.
Theminimumcontacttimeis5minutes.Ifadifferentdisinfectantisused,followthe
manufacturer’sinstructions.Pleasealsoconsiderthematerialcompatibilityforthe
medicaldevice.
3) Immersetheimmersiblepartoftheprobeintothedisinfectant(seeFig.3).Setaclock
toinsuretherecommendedcontacttimewhichis5minutes.
4) Rinsetheimmersiblepartoftheprobewithdeionizedwaterfor1minute.
(alternatively:immersetheimmersiblepartoftheprobeinatrayfilledwithdeionized
water(seeFig.3)for5min.)
5) Visuallychecktheoutersurfaceoftheprobeforleavingsofthedisinfectant.If
necessary,repeattherinsing.

4.4 Drying
1) Wipetheprobewithasingle‐use,fluff‐freewipeortoweltoremovemoisturefromthe
surfaceoftheprobe.
2) Drytheprobenaturallyinanambienttemperaturebetween15‐30°Cforaminimumof
4hours.Alternativelytheequipmentcanbedriedusingadryingheaterata
temperatureoflessthan50°C.

4.5 Inspection
Inspecttheequipmentforanydamagesuchascrack,scratchordeformation.Donotuseit
ifanydamageisfound.


Donotperformanysterilizationmethodswithpressurization,depressurizationandhigh
temperaturesuchasEO,steamandSTERRADsterilizationtothisprobe.Iftheprobeis
sterilizedbythesemethods,itsuffersseriousdamageandwillbeunusable.


Drying


‐8‐ Q1E‐EP1028

5. MaintenanceandSafetyInspection
5.1 Dailycheck
1) Visuallycheckthesurfaceoftheprobehead,housingandcableforanycrack,scratch
ordenaturalization.Ifyoufinddamage,donotusetheprobeandimmediatelycontact
aservicesupport.
2) Afterusingtheprobe,itshouldbecleanedanddisinfectedaccordingto“4.Cleaning
anddisinfection”,thenstoreitinacoolanddarkplaceavoidhightemperatureand
humidity,directsunlight.


‐9‐ Q1E‐EP1028

WARNING
CAUTION
6. SafetyPrecautions

Neverusetheprobeiftheprobehead,housingorcablearecrackedordamaged.
Warningincaseofusingprobecoverswhichlatexiscontainedto.Thelatexmay
causesuchallergicreactionsasitching,rubor,urticaria,swelling,fever,anhelation,
wheezing,depressionofbloodpressure,shockandsoon.Forthepatientssuspected
oflatexallergy,donotusethelatex‐containingmedicaldevices.Ifyourpatient
showsanyofabovementionedsymptomsduringtheoperation,stoptheuseofthe
latex‐containingmedicaldevicesimmediatelyandtakeanappropriatetreatmentto
thepatient.


Byexaminationofanearlypregnancytheexposuretimeshallbeasshortaspossible.
StartexaminationwithacousticoutputpowersettoL(Low).
Theprobeconnectorisnotwaterproof.Donotallowliquidtocontacttheconnector.
Donotdrop,hitorbenttheprobe.
Useonlywater,detergentsanddisinfectantsinthesupplierslist.Betweenuses,store
theprobeholderofscanner.
Understerileconditionuseappropriateprotectionforprobeandcable.SomeLatex
materialmaycreateallergicreactions.
Theacousticlensoftheprobeismanufacturedverythinanddelicatetogetthehigh
resolution.Therefore,incaseofwipingouttheultrasoundjellyorcleaningthe
surfaceoftheacousticlens,pleaseusethesoftclothortissuepaperandhandlewith
care.
Theprobeisnotdelivereddisinfected.
Neverusethisprobeexceptforitsintendeduse,vaginalorrectal.Ifyouusethisprobe
tothesurfaceofthehumanbodyforexaminations,thereisapossibilitytonegatively
affecttoperipheralmedicaldevicesbyelectromagneticdisturbancethatthisprobe
transmits.


‐10‐ Q1E‐EP1028

7. Specifications
7.1 Probe
Type:EUP‐VV531Transvaginalprobe
Centerfrequency:6MHz
Technology: ConvexArrayProbe
Dimensions:SeeFig.4.
Weight:Approx.1.0kg(incl.cableandconnector)
Scanningangle:150
Probematerials:Bio‐compatibleallergyfreecomponents
Acousticoutput:AccordingtoIEC60601‐2‐37(SeeMainUnitmanual.)
Applicablesystem:Dependingonproductionandupgradestatus.For
detailedinformationcontactaservicesupport.
Classification:MDDclassificationIIa.
Cleaning:Applicabledetergentsarelistedinthesupplierslist
Disinfection:Applicabledisinfectantsarelistedinthesupplierslist
Operatingconditions:
Ambienttemperature;25‐35C
Contactsurfacetemperature
(temperatureofexaminee);
max.42C
Relativehumidity;30‐85%
Storageconditions:
Temperature;‐10‐+55C
Relativehumidity;10‐95%(subjecttonocondensation)


‐11‐ Q1E‐EP1028

CAUTION
7.2 SuppliersList
TheproductslistedbelowareseriouslytestedandapprovedforusewiththeTransvaginal
ProbeEUP‐VV531.
ProductnameManufacturerPurpose
KlenzymeKlenzymeCleaner
STERANIOS2%ANIOSDisinfectant
GigaseptFFSchϋlke&MayrDisinfectant
CIDEXOPAJohnson&Johnson Disinfectant
CIDEXJohnson&Johnson Disinfectant
CIDEXPlusJohnson&Johnson Disinfectant
Nu‐CidexJohnson&Johnson Disinfectant
StabimedB.BraunDisinfectant
ALKAZYMEALKAPHARMCleaning‐disinfectant
PleasecontactyourlocaldistributorforacurrentversionoftheʺDisinfectant/Sterilization
MethodCompatibilityforUltrasoundProbeandAccessoryList”.

8. Disposaloftheprobe
Recycleordisposeequipmentproperlyincompliancewithyourorganizationalrulesand
yourlocallaws.

Beforedisposingequipment,disinfectortakeotherinfection‐preventionmeasures.
Disposalofequipmentwithouttakingtheproperpreventativemeasurescanleadto
infection.

WasteElectricalandElectronicEquipment(WEEE)Directive
TheillustrationontherightisrequiredbytheEUWEEEDirectivetoappearon
allelectricalandelectronicequipment.Forproperdisposalofthisproductin
anEUnation,contactanEUofficeoragencyandobserveappropriatelocaland
nationalregulationsandlaws.


‐12‐ Q1E‐EP1028

E
28.6
28.6
R12.5
2300
173
300
Fig.4Dimensionsoftheprobe Unit:mm



