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Caution!Federal(USA)lawCaution!Federal(USA)lawrestrictsthisproducttosalebyorontheorderofa 1825 5 _ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:2

_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:3 _ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:4 911Air13Power14FuseON/OFF電源開16Foot18Power19Spare sunitswithvariousaccessories.The EMS為設(shè)備提供多種附件。包 中列出了本裝置listshowsexactlywhatyourunit 體包括哪些附件TECHNICAL EMSreservestherighttomodifythe EMS保留隨著技術(shù)或科學(xué)的進(jìn)步而對(duì)技術(shù)、附件accessoriesoperatinginstructionsorcontents 套件操作說(shuō)明或內(nèi)容進(jìn)行修改之權(quán)_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:5DEARThankyouforpurchasingthisnewEMSproduct.ItmeetsthehighestqualityandsafetyTheSwissLithoClast2isap aticurologicallithotripterusedforthefragmentationofurinarytractcalculiinthekidney,ureterandbladder.UseoftheproductiscontraindicatedforpatientswiththeActivebleedingSolitaryfunctioningCreatininegreaterthanorequalto3μgDuringUndertheageofStrictureandobstructionWithanelectricalstimulatorimntede.g.PotentialPotentialcomplicationsassociatedwithfragmentationofurinarytractcalculiby aticenergyStone l_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:6 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)SwissLithoClast2是組合式超聲波和氣動(dòng)泌尿外科碎石機(jī),用于擊碎腎臟、輸尿管和 患有以下疾病的患者使用本產(chǎn)品活動(dòng)性凝血疾病單腎工作肌酸酐大于或等于3μg懷孕未滿18歲管道狹窄和梗阻問(wèn)題植入電刺激器,例如起搏器可 的并發(fā)癥利用氣動(dòng)和/或超聲波能量擊碎泌尿系 伴隨的潛在并發(fā)癥包括穿機(jī)轉(zhuǎn)疼痛/急腹肉眼血堵_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:7PLEASEREADTHISBEFOREBEGINNINGAboutthisThisinstructionmanualdescribes aticlithotripsyapplicationNotethattheEnglishversionofthismanualisthemasterfromwhichtranslationsderive.Incaseofdiscrepancy,thebindingversionistheEnglishTheseoperatinginstructionsaretoensurethecorrectinstallationanduseofthisproduct.Alwayskeepthisinstructioncloseathand.Pleasereadtheseoperatinginstructionscarefullyasthey PleasepayspecialattentiontothesafetyInstructionsconcerningthespecificcomponents(handpieces,probes)areprovidedseparayintherelativeinstructionsforuse.ReadtheinstructionmanualdeliveredwitheachofthecomponentsbeforeusingtheSwissLithoClast2.DonothesitatetocontactyourlocalEMSdealerforfurther_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:8關(guān)于本手本說(shuō)明手冊(cè)介紹了氣動(dòng)碎石應(yīng)用模式請(qǐng)注意,本手冊(cè)的譯文是根據(jù)英文版手冊(cè)翻譯而來(lái) 任 ,應(yīng)以英文版為準(zhǔn)此類操作說(shuō)明旨在確保正確安裝和使用本產(chǎn)品。請(qǐng)始終將本手冊(cè)放在手請(qǐng)仔細(xì)閱讀這些操作說(shuō)明,其中包含了重要的詳細(xì)信息和程序。請(qǐng)?zhí)貏e注意安全注意事項(xiàng)在相關(guān)使用說(shuō)明書中單獨(dú)提供有關(guān)特定組件(設(shè)備、治療手柄、壓縮機(jī))的說(shuō)明。在使SwissLithoClast2前,請(qǐng)閱讀隨每個(gè)組件附帶的說(shuō)明書。請(qǐng)隨時(shí)聯(lián)系當(dāng)?shù)谽MS經(jīng)銷商了解詳情_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:9 Topreventinjurytopeopleanddamagetoproperty,pleaseheedthecorrespondingdirectives.aremarkedasRiskofpatientoruserRiskofdamagetothedeviceorenvironmentalPleaseUsefuladditionalinformationandWewouldbepleasedtoansweryourquestionsorlistentoyoursuggestions.Wedo,ofcourse,provideWewishyoulotsofsuccess!_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:10為了預(yù)防人 和財(cái)產(chǎn)損壞,請(qǐng)注意相應(yīng)的指令。指令的標(biāo)記如下可能會(huì)損壞設(shè)備或破壞環(huán)請(qǐng)注其他有用的信息和提允樂(lè)意解答您的問(wèn)題或聽取您的建議。當(dāng)然,如果遇到技術(shù)問(wèn)題 電經(jīng)批準(zhǔn)的 維修中心或您的經(jīng)銷商希望您使用順利_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:11 ???8Operatingthe.... _d_01_0NSissilsi

4/25/201312:05:12安裝連接7913抽吸控制13氣動(dòng)碎預(yù)脈沖模19脈沖頻率1919激活19LithoVac2121內(nèi)窺鏡23治療建議2525警告3133 和滅菌35準(zhǔn)備和清潔3539更 安全注意事4產(chǎn) 47產(chǎn)品報(bào)廢49保修4949EMS5電磁兼容性59技術(shù)數(shù)據(jù)61_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:13 2_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:45 Clean,disinfectandsterilizeallthecomponentsbeforefirstuseandafterallsubsequentusesasdescribedinthe"ReprocessingInstructions"manual.Assembletheapplicationpartsundersterileconditions.Performfunctiontestingaccordingtotheinstructionsgivenintherespectiveaccessoryoperatinginstructionsmanual.Donotcovertheunit.Leaveaspaceof5cmaroundthedeviceforcooling.

行清潔、和除菌處理。在無(wú)菌條件下組裝應(yīng)用空間,以便進(jìn)行冷3_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 Useonlymedical-quality,drycompressedair,filteredataminimumof5μm.Thissupplyofcompressedaircanbeeither:Thecentralcompressedairsupplysystem(wallAseparateAcylinder(ISOConnectthefootpedalcordtotheunit.PayattentiontotheconnectorBesurethattheconnectorsareperfectlydrybeforemakingtheconnection.Todisconnect,onlytheconnectorsleeve.NeverpullonthecordConnectthepowersupplycordtotheunit.Topreventdamagetotheunit,checkthatitsratedvoltagemeetsthelocallinevoltage.ConnectonlytoaFIprotectedmainssupply(FI=ResidualcurrentToavoidtheriskofelectricshock,thisequipmentmustonlybeconnectedtoasupplymainswithprotectiveearth.NomodificationshallbemadeonthisThemainswitchoftheunitmustbeaccessibleatanyWhenthemainswitchisonthe“0”position,theunitisdisconnectedfromthesupplynetwork.Connecttheequipotentialplugtoothermedicaldevicesused,whenapplicable.4_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56推動(dòng)連接器,直至其卡入到位,將壓縮空氣導(dǎo)管的快速連接器連接至裝僅可使用醫(yī)療級(jí)品質(zhì)的干燥壓縮空氣系統(tǒng),最低以5μm進(jìn)行過(guò)濾。這種壓縮空氣供應(yīng)系統(tǒng)可以是壓縮空氣供應(yīng)系統(tǒng)(壁式插座獨(dú)立壓縮機(jī)氣缸(ISO7396將腳踏開關(guān)連接至裝置。請(qǐng)注意連接器方向 將電源線連接至裝置。為了避免損壞裝置,請(qǐng)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))。 必須能夠隨時(shí)接觸裝置的主開關(guān)當(dāng)主開關(guān)位于"0"位置時(shí),裝置與供電適當(dāng)情況下,將等電勢(shì)插頭連接至用到的其它醫(yī)療設(shè)備5_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 Disposablestonecatcher(providedThedisposableStoneCatcherdeviceisprovidedsterile.Readtheinstructionmanualdeliveredwithitbeforeperforminginstallation.Connecttheshortsiliconetubingendwiththeconicalconnectortotheexternalvacuumsourceandlongsiliconetubingtothelithovaclv3Installarollerclamponthesuctiontubingtoenablecontrolofthesuctionflowindependentlyofthelowerpressure.Thesteriledisposablestonecatcherdevicecannotbe6_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56采石器設(shè)備供貨時(shí)處于無(wú)菌狀態(tài)。請(qǐng)先閱讀隨附的使用說(shuō)明書,然后再進(jìn)行安裝將配有 連接器的短硅膠導(dǎo)管端連接至外部真空源,并將長(zhǎng)硅膠導(dǎo)管連接至lithovaclv3。在吸引管上安裝輥軸夾可啟動(dòng)對(duì)吸 量的控制,與較低的壓力無(wú)關(guān)。不能重新處理無(wú) 采石器設(shè)備7_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 Reusablestonecatcher(ACLPleaserefertotheinstructionsforuseofthereusablestonecatcherACLdeviceforfurtherdetailsonpreparationandoperation.8_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56有關(guān)準(zhǔn)備和操作 詳細(xì)信息,請(qǐng)參閱使用可重用采石器ACL設(shè)備的說(shuō)明9_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56StonecatcherdeviceTheuseofothertubingthantheone dwiththestonecatcherdevicecaneithercreateanpleteocclusionofthetubingintherollerclamp,orthetubingcancollapseduringuse.UseonlythestonecatcherdevicetubingprovidedbyEMS.Thesuctiontube(standardsuctiontubingwith3mlengthand5mminternaldiameter)mustbesterileandsingleuse.Useofatransparenttubingallowsforobservationoffragmenttransporttovisualizeapossibleobstruction.ThistypeofsuctiontubeisavailablefromEMSorcanbeprovidedbythehospital._ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56采石器設(shè)備導(dǎo)導(dǎo)管脫落。僅可使用EMS提供的采石器設(shè)備導(dǎo)管。吸引管(長(zhǎng)度為3m、內(nèi)徑為5mm的標(biāo)準(zhǔn)吸引管)必須處于無(wú)菌狀態(tài),并且只能使用一次。使用透明導(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??梢詮腅MS這種類型的吸引管,也可以_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56OPERATINGTHESuctionSuctionisonlyavailableinconjunctionwiththeLithoVaclv3handpiece.mendationsonsuctionsettingsforlithotripsyusingEMSlv3handpieceandprobesareprovidedseparay.SuctionflowcanbeadjustedbyusingtherollerclamponthesuctionEMSmendsusingtheEMSSwissLithoPump,especiallydesignedforthisapplicationoranothervacuumsourcewithlowerpressurecontrol.Alowerpressureof um-0.4barmustbeusedforallLithoVacsuctiontubesexceptforthe1.6mmtube.Whenusing1.6mmsuctiontubealowerpressureofatleast-0.7barmustgeneratedbytheExcessivesuctioncanimpairtheendoscopicview,collapsetheorgan,ordamagethemucosa.Itistheoperator’sresponsibilitytocontinuouslymonitorthesuctionflowtocheckthatitisopera-tionalandthattheleveloflowerpressureiscorrectly_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56僅當(dāng)與LithoVaclv3治療手柄結(jié)合使用時(shí),才能進(jìn)行抽吸。單獨(dú)提供關(guān)于使用EMSlv3治療手和探針進(jìn)行碎石的抽吸設(shè)置的建議可使用吸引管上的輥軸夾調(diào)節(jié)抽吸流量EMS建議使用專為該應(yīng)用設(shè)計(jì)的EMSSwissLithoPump或其他具有低壓控制功能的真空源。必須為全部LithoVac吸引管(1.6mm導(dǎo)管除外)使用較低壓力,最大值為0.4巴。使用1.6mm吸引管時(shí),泵機(jī)必須產(chǎn)生較低壓力,最小為0.7巴。抽吸壓力過(guò)高可能會(huì)削弱內(nèi)窺鏡可視效果、損傷或破壞粘膜應(yīng)由操作員負(fù)責(zé)持續(xù)抽吸流量,以檢查其可操作性以及設(shè)置的較低壓力水平是否正_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56FragmentsblockedinthelumenoftheLithoVacprobeandthehandpiecemayleadtolossofsuction.Ifblockageoccurs,stoplithotripsytoremovefragmentsfromtheprobeandfromthehandpiecelumenbeforecontinuing.Ifsuctionstopsbecauseofavacuumpumpfailure,recethevacuumpumporuseanvacuumsourcebeforecontinuing_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 ithoac探針和治療手柄內(nèi)腔中堵塞有碎片可能導(dǎo)致抽吸功能喪失。如果出現(xiàn)堵塞的情況,請(qǐng)停止碎石治療,并清除探針和治療手柄內(nèi)腔中的碎片,然后再繼續(xù)進(jìn)行治療。如果抽吸因真空泵故障而停止,請(qǐng)更換真空泵或使用其他真空源,然后再繼續(xù)進(jìn)行碎石_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 ATICBesurethatthecontrolunitisoffwhileconnectingtheTheStandby/ONbuttonlightwillturnorangewhenturningontheunit.PresstheStandby/ONbuttontostart._ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 確保連接治療手柄時(shí)控制裝置關(guān)閉啟動(dòng)裝置后,待機(jī)/啟動(dòng)按鈕燈將變?yōu)槌壬?。按待機(jī)/啟動(dòng)按鈕啟動(dòng)裝置_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56PulseSelecteithersingleormultiplepulsemodewiththepulsemodeselectionPulseWhenthepulsemodeissettomultiple,theleftrotaryknobisusedtoadjustthe aticfrequencyona2Hzto12Hz aticTherightrotaryknobisusedtoadjustthe aticPresstherightorleftfootpedaltoreleasethe atic_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 使用脈沖模式選擇按鈕選擇單脈沖模式或多脈沖模脈沖模式設(shè)為多脈沖模式時(shí),左側(cè)旋鈕用于調(diào)節(jié)氣動(dòng)脈沖頻率,范圍為2Hz到12Hz右側(cè)旋鈕用于調(diào)節(jié)氣動(dòng)功率按右側(cè)或左側(cè)腳踏開關(guān)釋放氣動(dòng)脈沖_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56Besurethatthecontrolunitisoffwhileconnectingthehandpiece.Neverconnectapartiallyassembledhandpiece.Whenusingpaticlithotripsy,thesuctionunitLithoVaclv3withsuctiontubescanbeaddedforasimultaneousevacuationoffragments.RefertothepatichandpieceinstructionmanualforSuctioniscontrolledwiththesuctioncontrolmanualvalveontheLithoVaclv3_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56LITHOVAC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使用氣動(dòng)碎石時(shí),可增加配有吸引管的抽吸裝置LithoVaclv3,以便同時(shí)排出碎片。有關(guān)詳情,參閱氣動(dòng)治療手柄使用說(shuō)明書通過(guò)LithoVaclv3療手柄上的手動(dòng)抽吸控制閥來(lái)控制抽吸情_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56Itmayhappenthattheprobetipishiddeninfoldsoftheedematoustissue.Endoscopeswitha5°to15°viewingangleofferabettervisualizationoftheprobetipinthenearrangeoftheendoscope.Whenusingureteroscopes,itismendedtouseahandpieceguidancetoobtainaproperprobetoendoscopealignmentandtolimittheextensionoftheprobesbeyondtheendoscopetip.GuidingadapterscanbepurchasedfromEMSforthemostcommonmodelsofEnsurethatthetipofthep aticprobedoesnotextendbeyondthetipoftheendoscopebymorethan10to20mmwhenitisfullyinsertedintheRiskofmucosalperforation:whenusinga0.8mmor1.0 aticprobewithanuretero-scope,itismendedtoadjust(ifneeded)thelengthoftheprobetotheendoscopelength.ContacttheEMSaftersalesservicetoadjusttheprobelengthtofitaparticularAdjustingthelengthoftheprobeandusingaguidingadapterwillhelplimitingtheriskofperforationToavoiddamagetotheendoscope,theprobesshouldnottheworkingchannelofthe_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56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的內(nèi)窺鏡可在內(nèi)窺鏡近距范使用輸尿管鏡時(shí),建議使用治療手柄導(dǎo)向裝置將探針與內(nèi)窺鏡正確對(duì)齊,并限制探針超出內(nèi)窺工作尖??蓮?適用于最常見的輸尿管鏡型號(hào)的導(dǎo)向適配器確保氣動(dòng)探針的工作尖完全插入到內(nèi)窺鏡工作通道時(shí)不會(huì)超出內(nèi)窺鏡工作尖10到20mm以上 :將0.8mm或1.0mm的氣動(dòng)探針與輸尿管鏡配合使用時(shí),建議將探針長(zhǎng)度調(diào)為 需要)。請(qǐng)聯(lián)系EMS 調(diào)節(jié)探針長(zhǎng)度并使用導(dǎo)向適配器有助于降低穿孔的風(fēng)險(xiǎn)并可減少能耗(特別是對(duì)于薄型探針)為了避免內(nèi)窺鏡損壞,工作尖仍留在內(nèi)窺鏡工作通道時(shí),不應(yīng)激活探針。_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 GeneralIntracorporeallithotripsybyuseofpaticenergyrequiresexperienceandskillinendoscopictechnique.Agoodbalanceofirrigationthroughtheendoscopeversussuctionisimportantforaproperendoscopicview.ExcessiveandbadlytimedflushingshouldbeavoidedinordernottoflushawaytheThestonecanonlybefragmentedifthepaticprobeisindirectcontactwithit.Beforereleasingapulse,touchthestonewiththeprobetipandmoveitslightlytoverifycontact.Duetothepushbackeffect, uretericstonesshouldnotbetreatedfrombelowwiththeprobepositionedinthecenterofthestone.Bestpracticeistopositiontheprobetangentiallyatthestonesothatthelithotripsypulseswillnotpushitback.ThestoneshouldbehitatthecornersorattheedgesdependingonitsItisusefultotreatthestonebypushingitslightlyagainsttheureterwallandworkingwithalowpulserate.Useofastonemigrationpreventiondevice(e.g.Dormiabasket)maybeindicated._ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56使用氣動(dòng)能量進(jìn)行體內(nèi)碎石需要具有內(nèi)窺鏡技術(shù)方面的經(jīng)驗(yàn)和技巧。良好地平衡通過(guò)內(nèi)窺鏡的沖洗流和抽吸壓力對(duì)于獲得正確的內(nèi)窺鏡視圖至關(guān)重要。應(yīng)避免沖洗時(shí)間過(guò)長(zhǎng)和過(guò)短,以免沖不 才會(huì)被擊碎。釋放脈沖之前,用探針工作尖接觸 應(yīng)敲 邊角處或邊緣處,具體取決于其結(jié)構(gòu)治療時(shí),輕輕推 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??赡苤甘臼罐D(zhuǎn)移預(yù)防設(shè)備(例如Dormia籃)_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 lithotripsygeneratesnoheat,thereforenoriskofthermaldamagetosurrounding_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56可以僅使用氣動(dòng)碎石療法直接治療受影響的 ,因?yàn)闅鈩?dòng)碎石不會(huì)產(chǎn)生熱量,因此不存在對(duì)周圍的織造成熱損傷的風(fēng)。_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56GeneraltreatmentItismendedtostartfragmentationatmediumpowersettingsof50%to60%.Theimpulsefrequencyselectionoffersvariouspossibilitiesthankstoadualfootpedalandavariablefrequencyselectorlsng

eO"

121212 2–12Highrange/MultiplepulseMultiplepulse2–12HzSingleimpulsereleaseperLowrange/SinglePulseTheadvantagefortheuseristhatheisableto lychoosebetweenapplicationofalowerorhigherpulserateonhisown,withouthavingtoaskathird(non- topressswitchesonthe_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 建議以50%到60%的中等功率設(shè)置開始進(jìn)行碎石。由于雙腳踏開關(guān)和可變頻率選擇2與12Hz之間進(jìn)行設(shè)置,因此脈沖頻率選擇可提供多種脈沖頻率選左側(cè)腳踏開多脈2–12高范圍/多沖模2–1212(最大對(duì)于用戶來(lái)說(shuō),其優(yōu)勢(shì)在于能夠隨意選擇使用較低脈沖速率還是較高脈沖速率,而不需要讓其他(非無(wú)菌)按動(dòng)設(shè)備上的開關(guān)_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56Dangerofurothelialandmucosalperforation!Duringtheentiretreatment,theusermustkeeptheprobetipsunderendoscopicview(theprobetipisextended10-20mmbeyondtheendoscopetip).Donotapplypressurewiththedistalpartoftheprobesagainsttissuesasdamagetotissuesperforationcouldoccur.UseparticularcautionwiththinTheuser’shandmayhaveatendencytopushforwardundertheinfluenceoftherepeatedpaticpulses.Thistendencymustbecorrectedbytheuserwhowillcontinuouslycontroltherelativepositionoftheprobetoreducerisksofperforations.Whenusingtheunitinmultiplepulsemode,besuretochecktheprogressoffragmentationandtheprobepositiononafrequentbasis(every1to2seconds).Sterilebackup aticlithotripsyprobesmustbeavailableintheeventofaprobefailureIfaprobebreaksdistally,usesterile pstoremoveprobepiecesfromtheurinary_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56存 和粘膜穿孔 !整個(gè)治療過(guò)程中,使用者必須保持探針工作尖位于內(nèi)窺鏡視野之(探針工作尖延伸至內(nèi)窺鏡工作尖10-20mm以上的位置)不得用探針末端對(duì)組織施壓,因?yàn)檫@樣可能會(huì)損傷組織或?qū)е陆M織穿孔。使用細(xì)探針時(shí)應(yīng)格外在重復(fù)發(fā)出的氣動(dòng)脈沖的影響下,使用者的手掌可能有向前推的趨勢(shì)。持續(xù)控制探針相對(duì)位置使用者必須及時(shí)調(diào)整這種趨勢(shì),以降低穿孔的風(fēng)險(xiǎn)隔秒如果治療過(guò)程中探針出現(xiàn)故障,必須可以使用經(jīng)過(guò)滅菌處理的備用氣動(dòng)碎石探針如果探針在遠(yuǎn)端損壞,應(yīng)使用無(wú)菌取物鑷將探針?biāo)槠瑥?中取。_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56EmptyingofsuctiontubesandstoneSuckairintoemptythesuctionTiltthestonecatcherdeviceinordertoemptythereceptaclebyEliminationorconservationofstonecatcherIffragmentsarenottobekept ysis,disposeofthestonefragmentsperhospitalIfthefragmentsaretobekept,closethereceptaclewiththetransportclosing_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56排空吸引管和采石吸入空氣,以排空吸引管傾斜放置采石器設(shè)備,通 排空容器除去或保留采石器內(nèi)容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(qǐng)用透明密封蓋封閉容器_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 CLEANING,DISINFECTINGANDPleaseconformtothemendationsoftheInstructions"manualdeliveredyourproductregardingprocedureofcleaning,packagingandsterilizingofthePleasefollowpresent-dayrulesaboutsterilizationapplicableinyourPreparationandThehousingoftheunitisnotwatertight.Pleaseproceedasfollows:TurnofftheDisconnectthepowersupplyconnector,Disconnecttheairsupplyconnector,Disconnectthefootpedalconnector,DisconnectthehandpieceandattachthecapsontotheCleantheunitonlywithanalcohol-based,commerciallycolorlessdisinfectantisopropanol).Theuseofscouringpowderoranabrasivespongewilldamageitssurface._ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 裝裝置的外殼不防水請(qǐng)按照以下步驟操關(guān)閉設(shè)備斷開電源連接器斷開空氣供應(yīng)系統(tǒng)連接器斷開腳踏開關(guān)連接器斷開治療手柄連接,并將鼻帽連接到連接器上僅可使用市場(chǎng)上銷售 類無(wú) 液(乙醇,異丙醇)清潔本裝置。使用擦洗粉或研磨海會(huì)損壞設(shè)備表_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 Cleanthefootpedalonlywithanalcohol-based,commerciallyavailable,colorlessdisinfectant(ethanol,isopropanol).Theuseofscouringpowderoranabrasivespongewilldamageitssurface.DisposeofthedisposablestonecatcherFortheothercomponents,pleaserefertorelatedinstruction_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56治療手柄和附僅可使用市場(chǎng)上銷售的 類無(wú)色 (乙醇,異丙醇)清潔本裝置。使用擦洗粉或研磨海綿會(huì)損壞設(shè)備表面。處 采石器設(shè)備有關(guān)其他組件,請(qǐng)參閱相關(guān)說(shuō)明手冊(cè)_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 Shouldlegalprovisionsinyourcountrydemandmaintenanceintervals,thesemustbe_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56如果您國(guó)家/地區(qū)的法律條款要求遵守一定 時(shí)間間隔,請(qǐng)務(wù)必遵守_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 cementofDisconnectthepowersupplycordatthebackoftheRecethefuseswiththosespecifiedonthe teatthebackoftheTestthecontrolunit.Ifthefuse"burns"again,pleasecontactyour_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 斷開設(shè)備后側(cè)的電源線用設(shè)備后側(cè)標(biāo)志牌上指定 絲進(jìn)行更換測(cè)試控制裝 。如 ?_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56SAFETYEMSandthedistributorofthisproductacceptnoliabilityfordirectorconsequentialinjuryordamageresultingfromimproperuse,arisinginparticularthroughnon-observanceoftheoperatinginstructions,orimproperpreparationandmaintenance.Readthisinstructionmanualbeforeusingthisdevice.Thisproductmayonlybeappliedforitsintendedusebyqualified nelandfortheapplicationsdescrbedinthismanual.Iftheunitisusedincombinationwithotherinstruments,pleaserefertotheirinstruction.Usefortheintendedpurposeonly.Beforeusingtheproduct,makesuretheoperatinginstructionstheoperatinginstructionsmayresultinthepatientorusersufferingseriousinjuryortheproductbeingRiskofexplosion:donotusethisproductinthepresenceofinfl bleanaestheticsorgases.Thisproductmustbeusedonlybytrainedand Alwaysexaminetheproductfordamagebeforecommencingtreatment.Damagedaccessoriesoradamagedunitmustnotbeusedandmustbereced.UseoriginalEMSsparepartsandaccessories_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56EMS和本產(chǎn)品的經(jīng)銷商對(duì)由于使用不當(dāng),特別是未按照操作說(shuō)明書操作、預(yù)備和 在使用本設(shè)備之前,請(qǐng)仔細(xì)閱讀使用說(shuō)明書。僅可用于預(yù)期目的。使用產(chǎn)品之前,請(qǐng)務(wù)必認(rèn)真閱讀使用說(shuō)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(shuō)明可能會(huì)對(duì)患者或用戶造成嚴(yán)重人身 :不要在有易燃麻醉劑或氣體的地方使用本產(chǎn)品只有經(jīng)過(guò)培訓(xùn)的專業(yè)人員才能使用本產(chǎn)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,則不得繼續(xù)使用,必須予以更換只使用原廠EMS備件和附件_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 Propercareandmaintenancearerequiredtoensuresafeoperationofmedicaldevices.EMSthereforemendsthatdevicesandinstrumentsbecheckedregularlyforproperfunctioningandcompleteness,uponreceiptandpriortoeachapplication,topreventinjurytopatientsandusers.ProductrepairsaretobeexecutedexclusivelythroughanapprovedEMSrepaircenter.Afteranyrepairormodification,thetechnicalsafetyofthedeviceandaccessoriesmustmeetthecorrespondingstandardapplicableforsuchequipment.Eachrepair,modificationortestmustberecordedinareport.Beforeeachuse,alwaysclean,disinfectandsterilizethedifferentpiecesandaccessoriesofthisproduct.Pleaserefertotheinformationprovidedinthe"ReprocessingInstructions"manualdeliveredwithyourproduct.Non-sterilepiecesandaccessoriesmaycausebacterialorviral_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 ,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(guò)批準(zhǔn)的 維修中心對(duì)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)安性必須符合適用于此類設(shè)備的相應(yīng)標(biāo)準(zhǔn)。每次修理、改進(jìn)或測(cè)試都必須在報(bào)告中進(jìn)行記錄 _ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56STORINGOFTHEKeeptheoriginalpackaginguntiltheproductistobedisposedofpermanently.Itcanbeusedfor orstoringatanytime.ShouldyouwishtostoretheproductforanextendedperiodofProceedasdescrbedinthechapter"Cleaning,disinfectingandPacktheproductandallaccessoriesintheoriginalPleaserefertothestorageandtransportconditionsinthechapter"Technical_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56保存好原廠包裝,直至產(chǎn)品完全報(bào)廢 時(shí)可能使用如果您希望較長(zhǎng)時(shí) 產(chǎn)品 將產(chǎn)品和所有附件放入原廠包裝 _ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56PRODUCTTheproductmustnotbediscardedindomestichouseholdShouldyouwishtodefinitivelydisposeoftheproduct,pleasecomplywiththeregulationswhichapplyinyourcountry.WasteElectricalandElectronicEquipmentbelongingtocustomerslocatedintheEuropeanUnionmayofshipfees,arecoveredbyEMS.Damagesduetonon-adherencetotheoperatinginstructionsorwearoutofpartsareexcludedfromThewarrantyofyourproductwillbecancelledifyoutrytoopenForsafetyreasonsthisproductmayonlybeusedwithgenuineEMSaccessories.Theuserassumesallrisksofusingthisproductwithnon-genuineaccessoriesorotherwiseinpliancewiththeinstructions_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56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(qǐng)遵照當(dāng)?shù)?根據(jù)WEEE ,歐盟國(guó)家客戶的廢舊電器可以寄送給EMS進(jìn)行回收處理?;?由EMS承擔(dān)。附件可以從EMS或任 的經(jīng)銷商獲得。請(qǐng)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件。果配合本產(chǎn)品使用非正品附件或不按照使用_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56EMSPleasecontactyourdealerorEMSrepaircenterforanyservicingorEMSdeclinesresponsibilityforthesafetyofthedeviceanddeclaresthewarrantynullandvoidifserviceorrepairiscarriedoutbyanunauthorizedthirdpartyorifnon-genuinesparepartsareused.Itisbesttoshipyourproductintheoriginalpackaging.ItprotectstheproductagainstdamageBeforedispatchingyourproductincludingallaccessories,pleaseclean,disinfectandsterilizeasdescribedintheoperatinginstructions.Riskoftransmittingmicro-organisms!Toprotectthe neloftherepaircenterandforsafetyreasonsduringtransportandshipment,allproductsandaccessoriesreturnedtothefactoryforrepairorrevisionmustbecleaned,disinfectedandsterilizedinaccordancewiththeinstructionmanual.Repaircanberefusedforproductoraccessoriesreceivedinacontaminatedcondition.WhensendingyourproductdirectlytotheapprovedEMSrepaircenter,pleaseincludethenameofdealertosimplify_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56EMS客戶服務(wù)請(qǐng)聯(lián)系您的經(jīng)銷商或EMS維修中心獲得任何保養(yǎng)或維修服務(wù)。如果由的 進(jìn)行過(guò)維修保養(yǎng)或使用非正品零配件,EMS 擔(dān)產(chǎn)品的安全責(zé)任 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(guò)程中損壞。在寄送產(chǎn)品(包括所有附件)之前,請(qǐng)按照操作說(shuō)明 說(shuō)明對(duì)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(guò)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(cè)進(jìn)行清潔、 和滅菌。如果收到的產(chǎn)品附件受到污染,則會(huì)拒絕維修。將產(chǎn)品直接寄送到經(jīng)過(guò)批準(zhǔn)的EMS 維修中心時(shí),請(qǐng)包括經(jīng)銷商的名稱以簡(jiǎn)化處理流程。_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 _ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 令_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56 _ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56絲_ed_2013_04_NotSwissLithoClast2.indd 4/25/201312:05:56CGOSTRmarkingforproduc

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