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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为设备提供多种附件。包装 EMS保留随着技术或科学的进步而对技术、 12/2/20133:40:5DEARThankyouforpurchasingthisnewEMSproduct.ItmeetsthehighestqualityandsafetyTheSwissLithoClast®Masterisacombinationultrasonicandp thefragmentationofurinarytractcalculiinthekidney,ureter,andbladder.UseoftheproductiscontraindicatedinpatientswiththeActivebleedingSolitaryfunctioningCreatininegreaterthanorequalto3µgDuringUndertheageofStrictureandobstructionWithanelectricalstimulator ntede.g.PotentialPotentialcomplicationsassociatedwithfragmentationofurinarytractcalculibyp aticand/orultrasoundenergyare:StoneMacroscopic l 12/2/20133:40:6 感谢 新款EMS产品。本系统符合最高的质量和安全标准SwissLithoClast®MASTER是组合式超声波和气动泌尿外科碎石机,用于击碎肾脏、输尿管和 3µg18岁可 的并发症利用气动和/或超声波能量击碎泌尿系 伴随的潜在并发症包括 12/2/20133:40:7Instructionsconcerningthespecificcomponents(handpieces,probes)areprovidedseparayintherelativeinstructionforuse.ReadtheinstructionmanualdeliveredwitheachofthecomponentsbeforeusingtheSwissLithoClastMaster.DonothesitatetocontactyourlocalEMSdealerforfurther 12/2/20133:40:8 在相关使用说明书中单独提供特定组件(治疗手柄、探针)的相关说明。在使用SwissLithoClastMASTEREMS经销商了解详情。 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 此类操作说明旨在确保正确安装和使用本产品。请始终将本手册放在手边。 的SwissLithoClastMASTER已禁用了气动碎石模式,则只能使用超声波碎石模式。在这种情 12/2/20133:40:11 Topreventinjurytopeopleanddamagetoproperty,pleaseheedthecorrespondingdirectives.Theyaremarkedasfollows:DangerRiskofpatientoruserCautionPleasenoteUsefuladditionalinformationand 12/2/20133:40:12 为了预防人 和财产损坏,请注意相应的指令。指令的标记如下乐意解答您的问题或听取您的建议。当然,如果遇到技术问题, 为您提供支持。请直接致电经批准的EMS 12/2/20133:40:13 Disposablestonecatcher Reusablestonecatcher Operatingthe...Suction.... Ultrasound _21ti..

12/2/20133:40:14 安 连 采石器设 可重用采石器设 操作装 抽吸控 1319占空 激 气动碎 准 脉冲模 23脉冲频 23气动功 激 23LithoVac 2525超声波和气动组合碎石模 预 内窥 治疗建 33常规建 33建议的设 在单独和组合模式之间进行选 警 39 12/2/20133:40:15 Post- procedureCleaning,disinfectingandsterilizingPreparationand Fuses precautionsStoringoftheproductProductdisposalEMScustomerService Electromagnetic data 12/2/20133:40:16 后处理步 43准备和清 丝更 �49安全注意 55产品报 57保 57附 57EMS客户服 59符 电磁兼容 技术数 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续使用之后,在无菌条件下组装应用零部件。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将电源线连接至装置。为了避免损坏装置,请检查其额定电压是否与当地的线路电压相符。仅可将装置连接至受FI保护的主电源(FI=残余电流保护)。仅可使用医疗级品质的干燥压缩空气系统,最低以5µm压缩空气供应系统(壁式插座气缸(ISO7396)将脚踏开关连接至装置。确保连接器完全干燥,然后再进行连接。要断开连接,只能拉动连接器套管; 5 12/2/20133:40:42 Disposablestonecatcher(provided ThedisposableStoneCatcherdeviceisprovidedsterile.Readtheinstructionmanualdeliveredwithitbeforeperforminginstallation.ConnecttheshortsiliconetubingendwiththeconicalconnectortotheexternalvacuumThepinchvalvedefaultstateisclosedandopenswhentheultrasound(left)footpedalisdepressedhalfway.Installarollerclamponthesuctiontubingtoenablecontrolofthesuctionflowindependentlyofthelowerpressure.Thesteriledisposablestonecatcherdevicecannotbereprocessed.6 12/2/20133:40:42 采石器设备供货时处于无菌状态。请先阅读随附的使用说明书,然后再进行安装。 吸 不能重新处理无 采石器设备7 12/2/20133:40:42 Reusablestonecatcherdevice(ACLonly)onpreparationandoperation.DonotinsertthesuctiontubingintothepinchvalvewhenworkingwiththeLithoVaclv3.TheLithoVachandpiecehasitsownmanualvalveforsuctioncontrol.8 12/2/20133:40:42 有关准备和操作 详细信息,请参阅使用可重用采石器ACL设备的说明操作LithoVaclv3时, 将吸引管插入夹管阀。LithoVac治疗手柄配有自身的手动阀,用于进9 12/2/20133:40:42 StonecatcherdeviceTheuseofothertubingthantheone dwiththestonecatcherdevicecaneithercreateanpleteocclusionofthetubinginthepinchvalve,orthetubingcancollapseduringuse.UseonlythestonecatcherdevicetubingprovidedbyEMS.Thesuctiontube(standardsuctiontubingwith3mlengthand5mminternaldiameter)mustbesterileandsingleuse.Useofatransparenttubingallowsforobservationoffragmenttransporttovisualizeapossibleobstruction.ThistypeofsuctiontubeisavailablefromEMSorcanbeprovidedbythehospital. 12/2/20133:40:42EMS吸引管(3m5mm)导管可以观察碎片传输情况,看清可能出现的堵塞现象。可以从EMS这种类型的吸引管,也可以 12/2/20133:40:42OPERATINGTHESuctionmendationsonsuctionsettingsforlithotripsyusingEMShandpiecesandprobesareprovidedsepara SuctionflowcanbeadjustedbyusingtherollerclamponthesuctionEMSmendsusingtheEMSSwissLithoPump,especiallydesignedforthisapplicationoranothervacuumsourcewithlowerpressureExcessivesuctioncanimpairtheendoscopicview,collapsetheorgan,ordamagethemucosa.Alwayscheckthatthesuctiontubingisinsertedintothepinchvalveandthatthepinchvalveisfunctioningproperly.Makesurethatsuctionisalwaysoperational.Continuoussuctionduringultrasoundlithotripsyisrequiredtoevacuatefragmentsandliquidsaswellastoensurethecoolingoftheprobeandthe 12/2/20133:40:42单独提供关于使用EMS治疗手柄和探针进行碎石的抽吸设置的建议。EMS建议使用专为该应用设计的EMSSwissLithoPump 或破坏粘膜。请务必检查吸引管是否插入夹 12/2/20133:40:42Aninterruptionofthesuctionmustbeavoided.Itisoperator’sresponsbilitytocontinuouslymonitorthesuctionflowtocheckthatitisoperationalandthattheleveloflowerpressureiscorrectlyset.Fragmentsblockedinthelumenoftheprobeandthehandpiecemayleadtolossofsuctionandheatingoftheprobe.Ifblockageoccurs,stoplithotripsytoremovefragmentsfromtheprobeandfromthehandpiecelumenbeforecontinuing.Ifsuctionstopsbecauseofavacuumpumpfailure,re cethevacuumpumporuseanalternativevacuumsourcebeforecontinuinglithotripsy. 12/2/20133:40:42必须避免中断抽吸过程。应由操作员负责持续 探针和治疗手柄内腔中堵有碎片可能导致探针的抽吸和加热功能丧失。如果出现堵塞的情况,请 12/2/20133:40:42ULTRASONICBesurethatthecontrolunitisoffwhileconnectingthehandpiece.Neverconnectapartiallyassembledhandpiece.TheStandby/Onbuttonlightwillturnorange5sec.afterturningontheunit.PresstheStandby/Onbuttontostartthecorrespondingmode. yedbrieflywhentheunitisturned 12/2/20133:40:42确保连接治疗手柄时控制装置关闭 连接部分组装的治疗手柄启动装置后,待机/启动按钮灯将变为橙色并持续亮起5秒钟。按下待机/启动按钮可启动相应的模式。 12/2/20133:40:42UltrasoundTheleftrotaryknobisusedtoadjusttheultrasoundpowerfrom10%to100%(in10%DutyThedutycycleistheratiobetweenultrasoundONandultrasoundOFFoveranintervaloftimeof80milliseconds.Setthedutycycleusingthearrowkeys.ThelastsettingofthedutycycleiskeptinmemoryatpowerThehandpieceandprobeerrordetectionispossibleonlywithadutycyclesetat%(seeTroubleshootingPresstheultrasoundfootpedalhalfwaytoactivatethesuction(pinchvalvePressthefootpedal ytoactivateultrasoundhandpiece,probe,and 12/2/20133:40:42 左侧旋钮用于调节超声波功率,范围为10%到100%(增量为10%)占空比是80毫秒的时间间隔内超声波开启和超声波关闭之间的比例。使用箭头键设置占空比。关仅当占空比设为将超声波脚踏开关按下一半可激活抽吸功能(夹管阀打开) 12/2/20133:40:42 ATICBesurethatthecontrolunitisoffwhileconnectingtheTheStandby/Onbuttonlightwillturnorange5sec.afterturningontheunit.PresstheStandby/Onbuttontostartthecorrespondingmode.Thecumulativenumberofpulsesis yedbrieflywhentheunitisturned 12/2/20133:40:42 确保连接治疗手柄时控制装置关闭。启动装置后,待机/启动按钮灯将变为橙色并持续亮起5秒钟。按下待机/启动按钮可启动相应的模式。装置启动时,会短暂显示累计的脉冲数。 12/2/20133:40:42PulseSelecteithersingleormultiplepulsemodewiththe"Lithomode"PulseWhenthepulsemodeissettomultiple,thefrequencycanbeselectedwiththearrowkeys.Frequencyisadjustableona1Hzto12Hzrange.Thelastsettingofthepulsemodeandfrequencyiskeptinmemoryatpoweroff. aticTherightrotaryknobisusedtoadjustthepaticpowerinpercentfrom0%to100%(in10%increments).Pressthe aticfootpedaltoreleasethe atic 12/2/20133:40:42 1Hz12Hz右侧旋钮用于调节气动功率,范围为0%到100%(增量为10%) 12/2/20133:40:42LITHOVACLV3BesurethatthecontrolunitisoffwhileconnectingtheWhenpaticlithotripsyisusedindividually,thesuctionunitLithoVaclv3withsuctiontubescanbeaddedforasimultaneousevacuationoffragments.Refertothepatichandpieceinstructionmanualfordetails.SuctioniscontrolledwiththesuctioncontrolmanualvalveontheLithoVaclv3 12/2/20133:40:42 确保连接治疗手柄时控制装置关闭。单独使用气动碎石时,可增加配有吸引管的抽吸装置LithoVaclv3,以便同时排空碎片。有关详通过LithoVaclv3治疗手柄上的手动抽吸控制阀来控制抽吸情况。 12/2/20133:40:42ULTRASOUNDAND ATICCOMBINEDLITHOTRIPSYBesurethatthecontrolunitisoffwhileconnectingthehandpiece.Neverconnectapartiallyassembledhandpiece.Connectthepre-assembledultrasonicandp atichandpieces(Refertotheultrasoundhandpiecemanualforhandpiecepreparationandassemblydetailsforcombinationmode). 12/2/20133:40:42 确保连接治疗手柄时控制装置关闭 连接部分组装的治疗手柄( 12/2/20133:40:42 Forpreparationandsettings,refertothechaptersonultrasoundand aticActivatetheultrasoundmodeaswellasthepaticmodeonthecontrolThe"Select"buttontogglesbetweentheadjustmentofthedutycycleandthesettingofthepaticpulsefrequency.Thefunctioninuseisindicatedbyadoteitherinthedutycycledisyorinthefrequencydisy.Thearrowkeysareusedtoadjustthevalues.Pressbothfootpedalstoactivatep aticandultrasoundlithotripsymodewithsuctionsimultaneously( cethefootoverbothpedals).Theindividuallithotripsymodescanbeselectivelycontrolledbypressingonlytherelatedfootpedal(leftforultrasound/rightforp 12/2/20133:40:42 有关准备和设置,请参阅关于超声波和气动碎石的章节。按下两个脚踏开关可同时激活气动和超声波碎石模式(将脚放在两个脚踏开关上)仅按下相关脚踏开关() 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 可能出现探针工作尖隐藏在水肿组织褶皱中的情况。视角为5°到15镜。从EMS 确保气动或超声波探针的工作尖完全插入到内窥镜工作通道时不会超出内窥镜工作尖10到20mm :将0.8mm或1.0mm的气动探针与输尿管镜配合使用时,建议将探针长度调为 需要)。请联系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 使用超和气动(同时或单独)。掉 。 推回。应敲 边角处或边缘处,具体取决于其结构 使其顶住输尿管壁,并使用较低的脉冲速率,这种方式非常有用。可能指示使用转移预防设备(例如Dormia篮)。 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 对于每种碎石方式,无论是单独使用还是组合使用,建议以50%到60%的中等功率设置开始进无论是单独使用还是与气动碎石组合使用,在开始时占空比设为100率不应高于7Hz,对于组合应用,建议将气动脉冲频率设为2~3Hz如果使用的占空比小于100%,例如,如果内窥镜程序需要降低通过超声波仪器的抽吸作用,会有 12/2/20133:40:42 SelectionbetweenindividualandcombinedTheSwissLithoClastMasterofferstwomodesoflithotripsy:Ultrasoundlithotripsyandpaticdirectimpactlithotripsy,knownastheSwissLithoClastprinciple.Thesetwolithotripsymodescanoperateincombinationorindividually.Theselectionofthetreatmentmodedependsonthestonelocationandonthestoneproperties.Stonefragmentationtestinghasbeenconductedtoverifythatsimultaneoususeofultrasoundandshockwavepaticlithotripsycanreducethetimeneededforstonefragmentationandevacuation.Insituationswhereitistimeconsumingandhardtofragmentthestonesbyusingultrasoundenergyalone,thesimultaneousapplicationofthepaticprobeguidedthroughtheultrasoundprobecanconsiderablyimprovetheprocess.Thisisparticularlytruewhentreatinghardstones,suchasmonohydratestones.Thecombineduseisnotindicatedwhenthefragmentationprocessworksfinewiththeultrasoundprobealone.Theflowcharacteristicoftheultrasoundprobeislimitedwhenthepaticprobeisinside.Fragmentevacuationismoreefficientwhenthesuctionchanneliskept. 12/2/20133:40:42SwissLithoClastMASTERSwissLithoClast原可以组合或单独操作这两种碎石模式。治疗模式的选择取决 位置以 的属性 击碎测试,以验证同时使用超声波和冲击波气动碎石可缩短碎石和排空所需的时间。在使 度地改善治疗过程。对于治疗硬 如果单独使用超声波探针便可准确进行碎石操作,则无需使用组合式应用。气动探针位于其内部时,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!由于超声波探针可能会使穿孔,而非将其,因此存在损害肾脏粘膜以及位于后方的的风险。整个治疗过程中,使用者必须保持探针工作尖位于内窥镜视野之中(探针工作尖延伸至内窥镜工作尖10-20mm以上的位置)。激活超声波之后 触摸超声波探针。探针的超声波振动可能导致变热和瞬间灼伤在多脉冲模式下使用装置时,请务必频繁(每隔1到2秒)检查碎石进度和探针位置。 12/2/20133:40:42EmptyingofsuctiontubesandstoneRemovethesiliconetubingofthestonecatcherfromthepinchSuckairintoemptythesuctionTiltthestonecatcherinordertoemptythereceptaclebyEliminationorconservationofstonecatcherIffragmentsarenottobekept ysis,disposeofthestonefragmentsperhospitalIfthefragmentsaretobekept,closethereceptaclewiththeyellowtransportclosing 12/2/20133:40:42倾斜放置采石器,通 排空容器如果不需要保留碎片进行分析,应按照医院的规定处 碎片如果要保 碎片,请用黄色透明密封盖封闭容器 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 液清洁本装置。使用擦洗粉或研磨海绵 12/2/20133:40:42 HandpiecesandCleanthefootpedalonlywithanalcohol-based,commerciallyavailable(ethanol,isopropanol),colorlessdisinfectant.Theuseofscouringpowderoranabrasivespongewilldamageitssurface.DisposeofthedisposablestonecatcherFortheothercomponents,pleaserefertorelatedinstruction 12/2/20133:40:42 液清洁脚踏开关。使用擦洗粉或研磨海处 采石器设备 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 备注:如果数字大于9999(秒),会显示小时模式,例如:012h=12小时。如果数字大于999h(小时),会使用指数模式:即,45E3=45x103=45’000备注9999,会使用指数模式例如:56E4=56x104=560’000 12/2/20133:40:42Fuses Disconnectthepowersupplycordatthebackofthe cethefuseswiththosespecifiedonthe teatthebackoftheTestthecontrolunit.Ifthefuse"burns"again,pleasecontactyour 12/2/20133:40:42用设备后侧标志牌上指定 丝进行更换 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和本产品的经销商对由于使用不当,特别是未按照使用说明书进行操作、预备和 在使用本设备之前,请仔细阅读使用说明书。本产品只能由具有资质的人员用于指定用途和本手仅可用于预期目的。使用产品之前,请务必认真阅读使用说明书。这一点同样适用于配合本产品使用的任何设备。未遵守操作说明可能会对患者或用户造成严重人身 开始治疗之前,务必检查产品是否损坏。如果附件或装置损坏,则不得再使用,必须予以更换。只使用原厂EMS备件和附件。 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 ,以确保医疗设备的安全操作性。因此,EMS建议定期检查设备和仪 只能由经过批准的EMS 维修中心对产品进行维修。维修或改进后,设备和附件的技术安全 和灭菌处理。请参阅随产品附带 12/2/20133:40:42STORINGOFTHE orstoringatanytime.ShouldyouwishtostoretheproductforanextendedperiodofPacktheproductandallaccessoriesintheoriginalPleaserefertothestorageandtransportconditionsinthe"Technicaldata" 12/2/20133:40:42保存好原厂包装,直至产品完全报废 时随时都可能用到它如果您希望较长时 产品 12/2/20133:40:42 PRODUCTTheproductmustnotbediscardedindomestichouseholdShouldyouwishtodefinitivelydisposetheproduct,pleasecomplywiththeregulationswhichapplyinyourcountry.WasteElectricalandElectronicEquipmentbelongingtocustomerslocatedintheEuropeanUnionmaybeshippedtoEMSforrecyclinginaccordancetotheWEEEregulations.Thecostsofrecycling,exclusiveofshipfees,arecoveredbyEMS.Damagesduetonon-adherencetotheoperatinginstructionsorwearoutofpartsareexcludedfromThewarrantyofyourproductwillbecancelledifyoutrytoopenAccessoriesareavailablefromEMSoranyauthorizeddealers.Pleasecontactyourcustomerservicedirectly.ForsafetyreasonsthisproductmayonlybeusedwithgenuineEMSaccessories.Theuserassumesallrisksofusingthisproductwithnon-genuineaccessoriesorotherwiseinpliancewiththeinstructions 12/2/20133:40:42 不得将本产品当作普通家 处理如果您想彻底将产品报废,请遵照当地 进行处理根据WEEE ,欧盟国家客户的废旧电器可以寄送给EMS进行回收处理。回 由EMS承担。附件可以从EMS或任 的经销商获得。请直接联系您的客户服务基于安全原因,本产品只能使用正品EMS附件。如果配合本产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客户服务请联系您的经销商或EMS维修中心寻求任何保养或维修服务。如果由的第 进行过维修保养或使用非正品零配件,EMS将 担产品的安全责任并 保修失效。最好采用原包装 产品。这样可以防止产品在 过程中损坏。在寄送产品(包括所有附件)之前,请按照操作说明 说明对其进行清洁、 和灭菌。微生物!为保护维修中心人员的健康以及基于运送过程中的安全原因,寄回厂家进行维修或改造的产品和附件必须按照使用手册进行清洁、和灭菌。如果收到的产品附件受到污染,则会拒绝维修。将产品直接寄送到经过批准的EMS维修中心时,请包括经销商的名称以简化处理流程。 12/2/20133:40:42 12/2/20133:40:42 12/2/20133:40:42 Litho 12/2/20133:40:42Litho

丝 12/2/20133:40:42 12/2/20133:40:42 号 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将非EMS指定或销售的附件和线缆用作更换部件可能会造成辐射增加或本产品 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:ClassIIbOperatingPrimaryØ5X20mmT4A250Compressedair3.5to6.5bar(3500to6500Width:360mmDepth:420OperatingTemperature+10°Cto+30°CRelativehumidity30%to75%Atmosphericpressure700hPato1060StorageandtransportTemperature–10°Cto+40°CRelativehumidity10%to95%Atmosphericpressure500hPato1060 12/2/20133:40:42EMSSA,CH-1260SwissLithoClast®Master电源(电压100–240电源(频率50–6050023–26.478约85EN-60601-1:I类应用的零件,BFIP20(IPX8)MDD93/42EEC:IIb类Ø5X20mmT4A2503.5至6.5巴(3500到6500重量:11135mm宽度:360mm深度:42010°C到+30℃相对湿度30%到75%大气压力700hPa到1060hPa 温度-10℃到+相对湿度10%到95%大气压力500hPa至1060hPa 12/2/20133:40:42 TheSwissLithoClastMasterprovid

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