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12 10 543bacfdbacfde 12/2/20133:40:2

12/2/20133:40:3 12/2/20133:40:4 listshowsexactlywhatyourunitincludes.TECHNICALEMSreservestherighttomodifythetechnique,accessories,operatinginstructionsorcontentsof

EMS為設(shè)備提供多種附件。包裝 EMS保留隨著技術(shù)或科學(xué)的進(jìn)步而對技術(shù)、 12/2/20133:40:5DEARThankyouforpurchasingthisnewEMSproduct.ItmeetsthehighestqualityandsafetyTheSwissLithoClast?Masterisacombinationultrasonicandp thefragmentationofurinarytractcalculiinthekidney,ureter,andbladder.UseoftheproductiscontraindicatedinpatientswiththeActivebleedingSolitaryfunctioningCreatininegreaterthanorequalto3μgDuringUndertheageofStrictureandobstructionWithanelectricalstimulator ntede.g.PotentialPotentialcomplicationsassociatedwithfragmentationofurinarytractcalculibyp aticand/orultrasoundenergyare:StoneMacroscopic l 12/2/20133:40:6 感謝 新款EMS產(chǎn)品。本系統(tǒng)符合最高的質(zhì)量和安全標(biāo)準(zhǔn)SwissLithoClast?MASTER是組合式超聲波和氣動泌尿外科碎石機(jī),用于擊碎腎臟、輸尿管和 3μg18歲可 的并發(fā)癥利用氣動和/或超聲波能量擊碎泌尿系 伴隨的潛在并發(fā)癥包括 12/2/20133:40:7Instructionsconcerningthespecificcomponents(handpieces,probes)areprovidedseparayintherelativeinstructionforuse.ReadtheinstructionmanualdeliveredwitheachofthecomponentsbeforeusingtheSwissLithoClastMaster.DonothesitatetocontactyourlocalEMSdealerforfurther 12/2/20133:40:8 在相關(guān)使用說明書中單獨(dú)提供特定組件(治療手柄、探針)的相關(guān)說明。在使用SwissLithoClastMASTEREMS經(jīng)銷商了解詳情。 12/2/20133:40:9 PLEASEREADTHISBEFOREBEGINNINGAboutthisNotethattheEnglishversionofthismanualisthemasterfromwhichtranslationsderive.Incaseofanydiscrepancy,thebindingversionistheEnglishtext.Theseoperatinginstructionsaretoensurethecorrectinstallationanduseofthisproduct.Alwayskeepthisinstructioncloseathand.Pleasereadtheseoperatinginstructionscarefullyastheyex inallthemostimportantdetailsandprocedures.Pleasepayspecialattentiontothesafetyprecautions.Thisinstructionmanualdescribescombinedultrasonicandp aticlithotripsy,aswellasultrasonicorp aticsinglelithotripsyapplicationmodes.IfyourSwissLithoClastMasterhasbeenpurchasedwiththepaticlithotripsymodedeactivated,onlytheultrasoundlithotripsymodecanbeused.Pleasereferinthiscaseonlytotheinstructionsforultrasoniclithotripsy. 12/2/20133:40:10 此類操作說明旨在確保正確安裝和使用本產(chǎn)品。請始終將本手冊放在手邊。 的SwissLithoClastMASTER已禁用了氣動碎石模式,則只能使用超聲波碎石模式。在這種情 12/2/20133:40:11 Topreventinjurytopeopleanddamagetoproperty,pleaseheedthecorrespondingdirectives.Theyaremarkedasfollows:DangerRiskofpatientoruserCautionPleasenoteUsefuladditionalinformationand 12/2/20133:40:12 為了預(yù)防人 和財(cái)產(chǎn)損壞,請注意相應(yīng)的指令。指令的標(biāo)記如下樂意解答您的問題或聽取您的建議。當(dāng)然,如果遇到技術(shù)問題, 為您提供支持。請直接致電經(jīng)批準(zhǔn)的EMS 12/2/20133:40:13 Disposablestonecatcher Reusablestonecatcher Operatingthe...Suction.... Ultrasound _21ti..

12/2/20133:40:14 安 連 采石器設(shè) 可重用采石器設(shè) 操作裝 抽吸控 1319占空 激 氣動碎 準(zhǔn) 脈沖模 23脈沖頻 23氣動功 激 23LithoVac 2525超聲波和氣動組合碎石模 預(yù) 內(nèi)窺 治療建 33常規(guī)建 33建議的設(shè) 在單獨(dú)和組合模式之間進(jìn)行選 警 39 12/2/20133:40:15 Post- procedureCleaning,disinfectingandsterilizingPreparationand Fuses precautionsStoringoftheproductProductdisposalEMScustomerService Electromagnetic data 12/2/20133:40:16 后處理步 43準(zhǔn)備和清 絲更 ?49安全注意 55產(chǎn)品報(bào) 57保 57附 57EMS客戶服 59符 電磁兼容 技術(shù)數(shù) 故障排 12/2/20133:40:17 ++2 12/2/20133:40:31 Clean,disinfectandsterilizeallthecomponentsbeforefirstuseandafterallsubsequentusesasdescribedinthe"ReprocessingInstructions"manual.Assembletheapplicationpartsundersterileconditions.Performfunctiontestingaccordingtotheinstructionsgivenintherespectiveaccessoryoperatinginstructionsmanual.Donotcovertheunit.Leaveaspaceof5cmaroundthedeviceforcooling.

第一次使用之前以及全部后續(xù)使用之后,在無菌條件下組裝應(yīng)用零部件。3 12/2/20133:40:42 Connectthepowersupplycordtotheunit.Topreventdamagetotheunit,checkthatitsratedvoltagemeetsthelocallinevoltage.ConnectonlytoaFIprotectedmainssupply(FI=Residualcurrentprotection).Connectthequickconnectorofthecompressedairtubetotheunit,bypushingtheconnectoruntilitclickson.Useonlymedical-quality,drycompressedair,filteredataminimumof5μm.Thissupplyofcompressedaircanbeeither:thecentralcompressedairsupplysystem(wallaseparateacylinder(ISOConnectthefootpedalcordtotheunit.PayattentiontotheconnectororientationandfastenthesecuringBesurethattheconnectorsareperfectlydrybeforemakingtheconnection.Todisconnect,pullonlytheconnectorsleeve;neverpullonthecorditself.4 12/2/20133:40:42將電源線連接至裝置。為了避免損壞裝置,請檢查其額定電壓是否與當(dāng)?shù)氐木€路電壓相符。僅可將裝置連接至受FI保護(hù)的主電源(FI=殘余電流保護(hù))。僅可使用醫(yī)療級品質(zhì)的干燥壓縮空氣系統(tǒng),最低以5μm壓縮空氣供應(yīng)系統(tǒng)(壁式插座氣缸(ISO7396)將腳踏開關(guān)連接至裝置。確保連接器完全干燥,然后再進(jìn)行連接。要斷開連接,只能拉動連接器套管; 5 12/2/20133:40:42 Disposablestonecatcher(provided ThedisposableStoneCatcherdeviceisprovidedsterile.Readtheinstructionmanualdeliveredwithitbeforeperforminginstallation.ConnecttheshortsiliconetubingendwiththeconicalconnectortotheexternalvacuumThepinchvalvedefaultstateisclosedandopenswhentheultrasound(left)footpedalisdepressedhalfway.Installarollerclamponthesuctiontubingtoenablecontrolofthesuctionflowindependentlyofthelowerpressure.Thesteriledisposablestonecatcherdevicecannotbereprocessed.6 12/2/20133:40:42 采石器設(shè)備供貨時(shí)處于無菌狀態(tài)。請先閱讀隨附的使用說明書,然后再進(jìn)行安裝。 吸 不能重新處理無 采石器設(shè)備7 12/2/20133:40:42 Reusablestonecatcherdevice(ACLonly)onpreparationandoperation.DonotinsertthesuctiontubingintothepinchvalvewhenworkingwiththeLithoVaclv3.TheLithoVachandpiecehasitsownmanualvalveforsuctioncontrol.8 12/2/20133:40:42 有關(guān)準(zhǔn)備和操作 詳細(xì)信息,請參閱使用可重用采石器ACL設(shè)備的說明操作LithoVaclv3時(shí), 將吸引管插入夾管閥。LithoVac治療手柄配有自身的手動閥,用于進(jìn)9 12/2/20133:40:42 StonecatcherdeviceTheuseofothertubingthantheone dwiththestonecatcherdevicecaneithercreateanpleteocclusionofthetubinginthepinchvalve,orthetubingcancollapseduringuse.UseonlythestonecatcherdevicetubingprovidedbyEMS.Thesuctiontube(standardsuctiontubingwith3mlengthand5mminternaldiameter)mustbesterileandsingleuse.Useofatransparenttubingallowsforobservationoffragmenttransporttovisualizeapossibleobstruction.ThistypeofsuctiontubeisavailablefromEMSorcanbeprovidedbythehospital. 12/2/20133:40:42EMS吸引管(3m5mm)導(dǎo)管可以觀察碎片傳輸情況,看清可能出現(xiàn)的堵塞現(xiàn)象。可以從EMS這種類型的吸引管,也可以 12/2/20133:40:42OPERATINGTHESuctionmendationsonsuctionsettingsforlithotripsyusingEMShandpiecesandprobesareprovidedsepara SuctionflowcanbeadjustedbyusingtherollerclamponthesuctionEMSmendsusingtheEMSSwissLithoPump,especiallydesignedforthisapplicationoranothervacuumsourcewithlowerpressureExcessivesuctioncanimpairtheendoscopicview,collapsetheorgan,ordamagethemucosa.Alwayscheckthatthesuctiontubingisinsertedintothepinchvalveandthatthepinchvalveisfunctioningproperly.Makesurethatsuctionisalwaysoperational.Continuoussuctionduringultrasoundlithotripsyisrequiredtoevacuatefragmentsandliquidsaswellastoensurethecoolingoftheprobeandthe 12/2/20133:40:42單獨(dú)提供關(guān)于使用EMS治療手柄和探針進(jìn)行碎石的抽吸設(shè)置的建議。EMS建議使用專為該應(yīng)用設(shè)計(jì)的EMSSwissLithoPump 或破壞粘膜。請務(wù)必檢查吸引管是否插入夾 12/2/20133:40:42Aninterruptionofthesuctionmustbeavoided.Itisoperator’sresponsbilitytocontinuouslymonitorthesuctionflowtocheckthatitisoperationalandthattheleveloflowerpressureiscorrectlyset.Fragmentsblockedinthelumenoftheprobeandthehandpiecemayleadtolossofsuctionandheatingoftheprobe.Ifblockageoccurs,stoplithotripsytoremovefragmentsfromtheprobeandfromthehandpiecelumenbeforecontinuing.Ifsuctionstopsbecauseofavacuumpumpfailure,re cethevacuumpumporuseanalternativevacuumsourcebeforecontinuinglithotripsy. 12/2/20133:40:42必須避免中斷抽吸過程。應(yīng)由操作員負(fù)責(zé)持續(xù) 探針和治療手柄內(nèi)腔中堵有碎片可能導(dǎo)致探針的抽吸和加熱功能喪失。如果出現(xiàn)堵塞的情況,請 12/2/20133:40:42ULTRASONICBesurethatthecontrolunitisoffwhileconnectingthehandpiece.Neverconnectapartiallyassembledhandpiece.TheStandby/Onbuttonlightwillturnorange5sec.afterturningontheunit.PresstheStandby/Onbuttontostartthecorrespondingmode. yedbrieflywhentheunitisturned 12/2/20133:40:42確保連接治療手柄時(shí)控制裝置關(guān)閉 連接部分組裝的治療手柄啟動裝置后,待機(jī)/啟動按鈕燈將變?yōu)槌壬⒊掷m(xù)亮起5秒鐘。按下待機(jī)/啟動按鈕可啟動相應(yīng)的模式。 12/2/20133:40:42UltrasoundTheleftrotaryknobisusedtoadjusttheultrasoundpowerfrom10%to100%(in10%DutyThedutycycleistheratiobetweenultrasoundONandultrasoundOFFoveranintervaloftimeof80milliseconds.Setthedutycycleusingthearrowkeys.ThelastsettingofthedutycycleiskeptinmemoryatpowerThehandpieceandprobeerrordetectionispossibleonlywithadutycyclesetat%(seeTroubleshootingPresstheultrasoundfootpedalhalfwaytoactivatethesuction(pinchvalvePressthefootpedal ytoactivateultrasoundhandpiece,probe,and 12/2/20133:40:42 左側(cè)旋鈕用于調(diào)節(jié)超聲波功率,范圍為10%到100%(增量為10%)占空比是80毫秒的時(shí)間間隔內(nèi)超聲波開啟和超聲波關(guān)閉之間的比例。使用箭頭鍵設(shè)置占空比。關(guān)僅當(dāng)占空比設(shè)為將超聲波腳踏開關(guān)按下一半可激活抽吸功能(夾管閥打開) 12/2/20133:40:42 ATICBesurethatthecontrolunitisoffwhileconnectingtheTheStandby/Onbuttonlightwillturnorange5sec.afterturningontheunit.PresstheStandby/Onbuttontostartthecorrespondingmode.Thecumulativenumberofpulsesis yedbrieflywhentheunitisturned 12/2/20133:40:42 確保連接治療手柄時(shí)控制裝置關(guān)閉。啟動裝置后,待機(jī)/啟動按鈕燈將變?yōu)槌壬⒊掷m(xù)亮起5秒鐘。按下待機(jī)/啟動按鈕可啟動相應(yīng)的模式。裝置啟動時(shí),會短暫顯示累計(jì)的脈沖數(shù)。 12/2/20133:40:42PulseSelecteithersingleormultiplepulsemodewiththe"Lithomode"PulseWhenthepulsemodeissettomultiple,thefrequencycanbeselectedwiththearrowkeys.Frequencyisadjustableona1Hzto12Hzrange.Thelastsettingofthepulsemodeandfrequencyiskeptinmemoryatpoweroff. aticTherightrotaryknobisusedtoadjustthepaticpowerinpercentfrom0%to100%(in10%increments).Pressthe aticfootpedaltoreleasethe atic 12/2/20133:40:42 1Hz12Hz右側(cè)旋鈕用于調(diào)節(jié)氣動功率,范圍為0%到100%(增量為10%) 12/2/20133:40:42LITHOVACLV3BesurethatthecontrolunitisoffwhileconnectingtheWhenpaticlithotripsyisusedindividually,thesuctionunitLithoVaclv3withsuctiontubescanbeaddedforasimultaneousevacuationoffragments.Refertothepatichandpieceinstructionmanualfordetails.SuctioniscontrolledwiththesuctioncontrolmanualvalveontheLithoVaclv3 12/2/20133:40:42 確保連接治療手柄時(shí)控制裝置關(guān)閉。單獨(dú)使用氣動碎石時(shí),可增加配有吸引管的抽吸裝置LithoVaclv3,以便同時(shí)排空碎片。有關(guān)詳通過LithoVaclv3治療手柄上的手動抽吸控制閥來控制抽吸情況。 12/2/20133:40:42ULTRASOUNDAND ATICCOMBINEDLITHOTRIPSYBesurethatthecontrolunitisoffwhileconnectingthehandpiece.Neverconnectapartiallyassembledhandpiece.Connectthepre-assembledultrasonicandp atichandpieces(Refertotheultrasoundhandpiecemanualforhandpiecepreparationandassemblydetailsforcombinationmode). 12/2/20133:40:42 確保連接治療手柄時(shí)控制裝置關(guān)閉 連接部分組裝的治療手柄( 12/2/20133:40:42 Forpreparationandsettings,refertothechaptersonultrasoundand aticActivatetheultrasoundmodeaswellasthepaticmodeonthecontrolThe"Select"buttontogglesbetweentheadjustmentofthedutycycleandthesettingofthepaticpulsefrequency.Thefunctioninuseisindicatedbyadoteitherinthedutycycledisyorinthefrequencydisy.Thearrowkeysareusedtoadjustthevalues.Pressbothfootpedalstoactivatep aticandultrasoundlithotripsymodewithsuctionsimultaneously( cethefootoverbothpedals).Theindividuallithotripsymodescanbeselectivelycontrolledbypressingonlytherelatedfootpedal(leftforultrasound/rightforp 12/2/20133:40:42 有關(guān)準(zhǔn)備和設(shè)置,請參閱關(guān)于超聲波和氣動碎石的章節(jié)。按下兩個(gè)腳踏開關(guān)可同時(shí)激活氣動和超聲波碎石模式(將腳放在兩個(gè)腳踏開關(guān)上)僅按下相關(guān)腳踏開關(guān)() 12/2/20133:40:42Itmayhappenthattheprobetipishiddeninfoldsoftheedematoustissue.Endoscopeswitha5°to15°viewingangleofferabettervisualizationoftheprobetipinthenearrangeoftheendoscope.Whenusingureteroscopes,itismendedtouseahandpieceguidancetoobtainaproperprobetoendoscopealignmentandtolimittheextensionoftheprobesbeyondtheendoscopetip.GuidingadapterscanbepurchasedfromEMSforthemostcommonmodelsofEnsurethatthetipofthepaticorultrasoundprobedoesnotextendbeyondthetipoftheendoscopebymorethan10to20mmwhenitisfullyinsertedintheendoscopeworkingchannel.Riskofmucosalperforation:Whenusinga0.8mmor1.0 aticprobewithanuretero-scope,itismendedtoadjust(ifneeded)thelengthoftheprobetotheendoscopelength.ContacttheEMSaftersalesservicetoadjusttheprobelengthtofitaparticularAdjustingthelengthoftheprobeandusingaguidingadapterwillhelplimittheriskofperforationandreducingenergyloss,particularlywiththinprobes.Toavoiddamagetotheendoscope,theprobesshouldnotbeactivatedwiththeirtipstillinsidetheworkingchannelofthe 12/2/20133:40:42 可能出現(xiàn)探針工作尖隱藏在水腫組織褶皺中的情況。視角為5°到15鏡。從EMS 確保氣動或超聲波探針的工作尖完全插入到內(nèi)窺鏡工作通道時(shí)不會超出內(nèi)窺鏡工作尖10到20mm :將0.8mm或1.0mm的氣動探針與輸尿管鏡配合使用時(shí),建議將探針長度調(diào)為 需要)。請聯(lián)系EMS (。 12/2/20133:40:42 Intracorporeallithotripsybyuseofultrasoundandpaticenergies,usedsimultaneouslyorindividually,requiresexperienceandskillinendoscopictechnique.Agoodbalanceofirrigationthroughtheendoscopeversussuctionisimportantforaproperendoscopicview.Excessiveandbadlytimedflushingshouldbeavoidedinordernottoflushawaythestone.Thestonecanonlybefragmentediftheultrasoundprobeand/orthepaticprobeis/areindirectcontactwithit.Beforereleasingapulseoractivatingtheultrasound,touchthestonewiththeprobetipandmoveitslightlytoverifycontact.Duetothepushbackeffect, uretericstonesshouldnotbetreatedfrombelowwiththeprobepositionedinthecenterofthestone.Bestpracticeistopositiontheprobetangentiallyatthestonesothatthelithotripsypulseswillnotpushitback.ThestoneshouldbehitatthecornerorattheedgesdependingonitsItisusefultotreatthestonebypushingitslightlyagainsttheureterwallandworkingwithalowpulserate.Useofastonemigrationpreventiondevice(e.g.Dormiabasket)maybeindicated. 12/2/20133:40:42 使用超和氣動(同時(shí)或單獨(dú))。掉 。 推回。應(yīng)敲 邊角處或邊緣處,具體取決于其結(jié)構(gòu) 使其頂住輸尿管壁,并使用較低的脈沖速率,這種方式非常有用??赡苤甘臼褂棉D(zhuǎn)移預(yù)防設(shè)備(例如Dormia籃)。 12/2/20133:40:42Itispossibletotreatimpactedstonesdirectly"insitu"usingonlyp aticlithotripsy,becausep mendedForeachlithotripsymethod,whetherusedindividuallyorincombination,itismendedtostartfragmentationatmediumpowersettingsof50%to60%.%atthebeginningwhetherusedaloneorincombinationwithp ordecreasedgradually.Forcombinedapplication,itismendedtosetthep aticpulsesfrequencyat2~3Hztohelpcontrollingthefragmentation.Workingwithadutycycleoflessthan100%canbehelpfultoreducewarm-upoftheultrasoundinstrument 12/2/20133:40:42 對于每種碎石方式,無論是單獨(dú)使用還是組合使用,建議以50%到60%的中等功率設(shè)置開始進(jìn)無論是單獨(dú)使用還是與氣動碎石組合使用,在開始時(shí)占空比設(shè)為100率不應(yīng)高于7Hz,對于組合應(yīng)用,建議將氣動脈沖頻率設(shè)為2~3Hz如果使用的占空比小于100%,例如,如果內(nèi)窺鏡程序需要降低通過超聲波儀器的抽吸作用,會有 12/2/20133:40:42 SelectionbetweenindividualandcombinedTheSwissLithoClastMasterofferstwomodesoflithotripsy:Ultrasoundlithotripsyandpaticdirectimpactlithotripsy,knownastheSwissLithoClastprinciple.Thesetwolithotripsymodescanoperateincombinationorindividually.Theselectionofthetreatmentmodedependsonthestonelocationandonthestoneproperties.Stonefragmentationtestinghasbeenconductedtoverifythatsimultaneoususeofultrasoundandshockwavepaticlithotripsycanreducethetimeneededforstonefragmentationandevacuation.Insituationswhereitistimeconsumingandhardtofragmentthestonesbyusingultrasoundenergyalone,thesimultaneousapplicationofthepaticprobeguidedthroughtheultrasoundprobecanconsiderablyimprovetheprocess.Thisisparticularlytruewhentreatinghardstones,suchasmonohydratestones.Thecombineduseisnotindicatedwhenthefragmentationprocessworksfinewiththeultrasoundprobealone.Theflowcharacteristicoftheultrasoundprobeislimitedwhenthepaticprobeisinside.Fragmentevacuationismoreefficientwhenthesuctionchanneliskept. 12/2/20133:40:42SwissLithoClastMASTERSwissLithoClast原可以組合或單獨(dú)操作這兩種碎石模式。治療模式的選擇取決 位置以 的屬性 擊碎測試,以驗(yàn)證同時(shí)使用超聲波和沖擊波氣動碎石可縮短碎石和排空所需的時(shí)間。在使 度地改善治療過程。對于治療硬 如果單獨(dú)使用超聲波探針便可準(zhǔn)確進(jìn)行碎石操作,則無需使用組合式應(yīng)用。氣動探針位于其內(nèi)部時(shí),超 12/2/20133:40:42extended10-20mmbeyondtheendoscopetip).Donotapplypressurewiththedistalpartoftheprobesagainsttissuesasdamagetotissueorperforationcouldoccur.Useparticularcautionwiththinprobes.Donottouchtheultrasoundprobewhenultrasoundisactivated.Theultrasoundvbrationsoftheprobesmaycauseheatandinstantburns.Theuser’shandmayhaveatendencytopushforwardundertheinfluenceoftherepeatedpaticpulses.Thistendencymustbecorrectedbytheuserwhowillcontinuouslycontroltherelativepositionoftheprobetoreducerisksofperforations.Whenusingtheunitinmultiplepulsemode,besuretochecktheprogressoffragmentationandtheprobepositiononafrequentbasis(every1to2seconds).Sterilebackupultrasoundandp aticlithotripsyprobesmustbeavailableintheeventofaprobefailureduringtreatment. pstoremoveprobepiecesfromtheurinary 12/2/20133:40:42存在和粘膜穿孔的!由于超聲波探針可能會使穿孔,而非將其,因此存在損害腎臟粘膜以及位于后方的的風(fēng)險(xiǎn)。整個(gè)治療過程中,使用者必須保持探針工作尖位于內(nèi)窺鏡視野之中(探針工作尖延伸至內(nèi)窺鏡工作尖10-20mm以上的位置)。激活超聲波之后 觸摸超聲波探針。探針的超聲波振動可能導(dǎo)致變熱和瞬間灼傷在多脈沖模式下使用裝置時(shí),請務(wù)必頻繁(每隔1到2秒)檢查碎石進(jìn)度和探針位置。 12/2/20133:40:42EmptyingofsuctiontubesandstoneRemovethesiliconetubingofthestonecatcherfromthepinchSuckairintoemptythesuctionTiltthestonecatcherinordertoemptythereceptaclebyEliminationorconservationofstonecatcherIffragmentsarenottobekept ysis,disposeofthestonefragmentsperhospitalIfthefragmentsaretobekept,closethereceptaclewiththeyellowtransportclosing 12/2/20133:40:42傾斜放置采石器,通 排空容器如果不需要保留碎片進(jìn)行分析,應(yīng)按照醫(yī)院的規(guī)定處 碎片如果要保 碎片,請用黃色透明密封蓋封閉容器 12/2/20133:40:42 CLEANING,DISINFECTINGANDPleaseconformtothemendationsofthe"ReprocessingInstructions"manualdeliveredwithyourproductregardingprocedureofcleaning,disinfecting,packaginandsterilizingofthePleasefollowpresent-dayrulesaboutsterilizationapplicableinyourPreparationandThehousingoftheunitisnotwatertight.Pleaseproceedasfollows:Turnoffthedevice, Disconnectthepowersupplyconnector,Disconnecttheairsupplyconnector,Disconnectthefootpedalconnector,Disconnectthehandpiece(s)andattachthecapsontotheCleantheunitonlywithanalcohol-based,commerciallyavailable(ethanol,isopropanol),colorlessdisinfectant.Theuseofscouringpowderoranabrasivespongewilldamageitssurface. 12/2/20133:40:42 液清潔本裝置。使用擦洗粉或研磨海綿 12/2/20133:40:42 HandpiecesandCleanthefootpedalonlywithanalcohol-based,commerciallyavailable(ethanol,isopropanol),colorlessdisinfectant.Theuseofscouringpowderoranabrasivespongewilldamageitssurface.DisposeofthedisposablestonecatcherFortheothercomponents,pleaserefertorelatedinstruction 12/2/20133:40:42 液清潔腳踏開關(guān)。使用擦洗粉或研磨海處 采石器設(shè)備 12/2/20133:40:42Shouldlegalprovisionsinyourcountrydemandmaintenanceintervals,thesemustbe yofthesoftwareWhenthedeviceisturnedon,theinstalledsoftwareversionis yedforfew yofcumulatedoperationDuringpowerup,thetotaltimeofultrasoundusageaswellasthetotalnumberofp aredis yedintherelateddis ysonfrontpanel.UltrasoundThecumulativeultrasoundusagetime[seconds/hours]isshownbrieflyontheleft yatstart-Remark:Ifthenumberissuperiorto9999(seconds),thehoursmodeisshown,forexample:012h=12hours.Ifthenumberissuperiorto999h(hours),theexponentialmodeisused:i.e.45E3=45x103=45’000 aticpulseThecumulativenumberofpulsesisshownbrieflyontheright yatstart-Remark:Ifthenumberissuperiorto9999,theexponentialmodeisusedForexample:56E4=56x104=560’000 12/2/20133:40:42 備注:如果數(shù)字大于9999(秒),會顯示小時(shí)模式,例如:012h=12小時(shí)。如果數(shù)字大于999h(小時(shí)),會使用指數(shù)模式:即,45E3=45x103=45’000備注9999,會使用指數(shù)模式例如:56E4=56x104=560’000 12/2/20133:40:42Fuses Disconnectthepowersupplycordatthebackofthe cethefuseswiththosespecifiedonthe teatthebackoftheTestthecontrolunit.Ifthefuse"burns"again,pleasecontactyour 12/2/20133:40:42用設(shè)備后側(cè)標(biāo)志牌上指定 絲進(jìn)行更換 12/2/20133:40:42SAFETYEMSandthedistributorofthisproductacceptnoliabilityfordirectorconsequentialinjuryordamageresultingfromimproperuse,arisinginparticularthroughnon-observanceoftheoperatinginstructions,orimproperpreparationandmaintenance.Readthisinstructionmanualbeforeusingthisdevice.Thisproductmayonlybeappliedforitsintendedusebyqualified nelandfortheapplicationsdescrbedinthismanual.Iftheunitisusedincombinationwithotherinstruments,pleaserefertotheirinstruction.havebeencarefullystudied.Thisalsoappliestoanyequipmentusedwiththisproduct.FailuretoobservetheoperatinginstructionsmayresultinthepatientorusersufferingseriousinjuryortheproductbeingRiskofexplosion:Donotusethisproductinthepresenceofinflbleanaestheticsorgases.Thisproductmustbeusedonlybytrainedand adamagedunitmustnotbeusedandmustbereced.UseoriginalEMSsparepartsandaccessories 12/2/20133:40:42EMS和本產(chǎn)品的經(jīng)銷商對由于使用不當(dāng),特別是未按照使用說明書進(jìn)行操作、預(yù)備和 在使用本設(shè)備之前,請仔細(xì)閱讀使用說明書。本產(chǎn)品只能由具有資質(zhì)的人員用于指定用途和本手僅可用于預(yù)期目的。使用產(chǎn)品之前,請務(wù)必認(rèn)真閱讀使用說明書。這一點(diǎn)同樣適用于配合本產(chǎn)品使用的任何設(shè)備。未遵守操作說明可能會對患者或用戶造成嚴(yán)重人身 開始治療之前,務(wù)必檢查產(chǎn)品是否損壞。如果附件或裝置損壞,則不得再使用,必須予以更換。只使用原廠EMS備件和附件。 12/2/20133:40:42 Propercareandmaintenancearerequiredtoensuresafeoperationofmedicaldevices.EMSthereforemendsthatdevicesandinstrumentsbecheckedregularlyforproperfunctioningandcompleteness,uponreceiptandpriortoeachapplication,topreventinjurytopatientsandusers.ProductrepairsaretobeexecutedexclusivelythroughanapprovedEMSrepaircenter.Afteranyrepairormodification,thetechnicalsafetyofthedeviceandaccessoriesmustmeetthecorrespondingstandardapplicableforsuchequipment.Eachrepair,modificationortestmustberecordedinareport.Beforeeachuse,alwaysclean,disinfectandsterilizethedifferentpiecesandaccessoriesofthisproduct.Pleaserefertotheinformationprovidedinthe"ReprocessingInstructions"manualdeliveredwithyourproduct.Non-sterilepiecesandaccessoriesmaycausebacterialorviral 12/2/20133:40:42 ,以確保醫(yī)療設(shè)備的安全操作性。因此,EMS建議定期檢查設(shè)備和儀 只能由經(jīng)過批準(zhǔn)的EMS 維修中心對產(chǎn)品進(jìn)行維修。維修或改進(jìn)后,設(shè)備和附件的技術(shù)安全 和滅菌處理。請參閱隨產(chǎn)品附帶 12/2/20133:40:42STORINGOFTHE orstoringatanytime.ShouldyouwishtostoretheproductforanextendedperiodofPacktheproductandallaccessoriesintheoriginalPleaserefertothestorageandtransportconditionsinthe"Technicaldata" 12/2/20133:40:42保存好原廠包裝,直至產(chǎn)品完全報(bào)廢 時(shí)隨時(shí)都可能用到它如果您希望較長時(shí) 產(chǎn)品 12/2/20133:40:42 PRODUCTTheproductmustnotbediscardedindomestichouseholdShouldyouwishtodefinitivelydisposetheproduct,pleasecomplywiththeregulationswhichapplyinyourcountry.WasteElectricalandElectronicEquipmentbelongingtocustomerslocatedintheEuropeanUnionmaybeshippedtoEMSforrecyclinginaccordancetotheWEEEregulations.Thecostsofrecycling,exclusiveofshipfees,arecoveredbyEMS.Damagesduetonon-adherencetotheoperatinginstructionsorwearoutofpartsareexcludedfromThewarrantyofyourproductwillbecancelledifyoutrytoopenAccessoriesareavailablefromEMSoranyauthorizeddealers.Pleasecontactyourcustomerservicedirectly.ForsafetyreasonsthisproductmayonlybeusedwithgenuineEMSaccessories.Theuserassumesallrisksofusingthisproductwithnon-genuineaccessoriesorotherwiseinpliancewiththeinstructions 12/2/20133:40:42 不得將本產(chǎn)品當(dāng)作普通家 處理如果您想徹底將產(chǎn)品報(bào)廢,請遵照當(dāng)?shù)?進(jìn)行處理根據(jù)WEEE ,歐盟國家客戶的廢舊電器可以寄送給EMS進(jìn)行回收處理。回 由EMS承擔(dān)。附件可以從EMS或任 的經(jīng)銷商獲得。請直接聯(lián)系您的客戶服務(wù)基于安全原因,本產(chǎn)品只能使用正品EMS附件。如果配合本產(chǎn)品使用非正品附件或不按照使用 12/2/20133:40:42EMSCUSTOMERPleasecontactyourdealerorEMSrepaircenterforanyservicingorEMSdeclineresponsibilityforthesafetyofthedeviceanddeclarethewarrantynullandvoidifserviceorrepairiscarriedoutbyanunauthorizedthirdpartyorifnon-genuinesparepartsareused.Itisbesttoshipyourproductintheoriginalpackaging.Itprotectsyourproductagainstdamageduringdescribedintheoperatinginstructions.Riskoftransmittingmicro-organisms!Toprotectthe neloftherepaircenterandforsafetyrevisionmustbecleaned,disinfectedandsterilizedinaccordancewiththeinstructionsmanual.Repaircanberefusedforproductoraccessoriesreceivedinacontaminatedcondition.WhensendingyourproductdirectlytotheapprovedEMSrepaircenter,pleaseincludethenameofthedealertosimplifyprocessing. 12/2/20133:40:42 EMS客戶服務(wù)請聯(lián)系您的經(jīng)銷商或EMS維修中心尋求任何保養(yǎng)或維修服務(wù)。如果由的第 進(jìn)行過維修保養(yǎng)或使用非正品零配件,EMS將 擔(dān)產(chǎn)品的安全責(zé)任并 保修失效。最好采用原包裝 產(chǎn)品。這樣可以防止產(chǎn)品在 過程中損壞。在寄送產(chǎn)品(包括所有附件)之前,請按照操作說明 說明對其進(jìn)行清潔、 和滅菌。微生物!為保護(hù)維修中心人員的健康以及基于運(yùn)送過程中的安全原因,寄回廠家進(jìn)行維修或改造的產(chǎn)品和附件必須按照使用手冊進(jìn)行清潔、和滅菌。如果收到的產(chǎn)品附件受到污染,則會拒絕維修。將產(chǎn)品直接寄送到經(jīng)過批準(zhǔn)的EMS維修中心時(shí),請包括經(jīng)銷商的名稱以簡化處理流程。 12/2/20133:40:42 12/2/20133:40:42 12/2/20133:40:42 Litho 12/2/20133:40:42Litho

絲 12/2/20133:40:42 12/2/20133:40:42 號 12/2/20133:40:42 12/2/20133:40:42 12/2/20133:40:42 ELECTROMAGNETICThisproductneedsspecialprecautionsregardingelectromagneticcompatbilityandneedstobeinstalledandputintoserviceaccordingtothenote"Electromagneticcompatibility".Certaintypesof municationequipmentcouldpotentiallyinterferewiththisproduct.Theseparationdistancesmendedinthenote"Electromagneticcompatbility"mustbetakenintoaccount.Thisproductshouldnotbeusedadjacenttoorstackedwithanotherunit.Ifadjacentorstackeduseisnecessary,functioningshouldbeverifiedpriortooperationintheconfigurationinwhichitwillbeTheuseofaccessoriesandcordsotherthanthosespecifiedorsoldbyEMSasre cementpartsmayresultinincreasedemissionsordecreasedimmunityofthis 12/2/20133:40:42將非EMS指定或銷售的附件和線纜用作更換部件可能會造成輻射增加或本產(chǎn)品 性降低 12/2/20133:40:42 TECHNICALEMSEMSSA,CH–1260Nyon,SwissLithoClast?Powersupply100–240Powersupply50–60Power50023–26.478EnergyAppro.85EN-60601-1:ClassAppliedpartIP20(Footpedal:IPX8)MDD93/42EEC:ClassIIbOperatingPrimary?5X20mmT4A250Compressedair3.5to6.5bar(3500to6500Width:360mmDepth:420OperatingTemperature+10°Cto+30°CRelativehumidity30%to75%Atmosphericpressure700hPato1060StorageandtransportTemperature–10°Cto+40°CRelativehumidity10%to95%Atmosphericpressure500hPato1060 12/2/20133:40:42EMSSA,CH-1260SwissLithoClast?Master電源(電壓100–240電源(頻率50–6050023–26.478約85EN-60601-1:I類應(yīng)用的零件,BFIP20(IPX8)MDD93/42EEC:IIb類?5X20mmT4A2503.5至6.5巴(3500到6500重量:11135mm寬度:360mm深度:42010°C到+30℃相對濕度30%到75%大氣壓力700hPa到1060hPa 溫度-10℃到+相對濕度10%到95%大氣壓力500hPa至1060hPa 12/2/20133:40:42 TheSwissLithoClastMasterprovid

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