ems dental产品说明书mode demploi perio flow syst针对的附加安全建议

3/16/20154:43:34 3/16/20154:43:34Caution!Federal(USA)lawrestrictsthisdevicetosalebyorontheorderofadentist. 51 3/16/20154:43:35

3/16/20154:43:35 TECHNICALEMSreservestherighttomodifythetechnique,accessories,

EMS保留随着技术或科学的进步而对技术、附件、套件明或内容进行修改之权利DEAR

ThankyouforbuyinganewEMSproduct.ItmeetsthehighestandsafetyThissystemisforuseindentistrywithEMSAIR-FLOWThisproductmustonlybeusedbyaqualifiedandtrained (dentistordentalhygienist).Thisproductshouldonlybeusedwithpowders dbyEMSforasubgingivalapplication.Thisproductremovethesubgingivalbiofilmduringperiodicperiodontaltreatments.Itslongfinenozzlewasspecificallydevelopedforeasyaccesstotheperiodontalpocket.

新款EMS产品。本系统符合最高的质量和安全标准。本系统用于采用EMSAIR-FLOW装置的牙科诊所中。本产品必须只能由经过培训的合格人员(牙医或牙 员)使用本产品应只与EMS提供的牙粉一同用于龈下清 该产品专门设 3/16/20154:43:35 PLEASEREADTHISBEFOREBEGINNINGThisoperationinstructionsaretoensurethecorrectinstallationanduseofthisproduct.Pleasereadtheseoperationinstructionscarefullyastheyexinallthemostimportantdetailsandprocedures.Pleasepayspecialattentiontothesafetyprecautions.AlwayskeepthisinstructioncloseatTopreventinjurytopeopleanddamagetopro-perty,pleaseheedthecorrespondingdirectives.TheyaremarkedasRiskofRiskofpropertydamageorenvironmentalPleaseUsefuladditionalinformationand

本使用说明旨在确保正确安装和使用本产请仔细阅读这些使用说明，其中包含了所有最重要的详细信息和程序。特别注意安全注意事请始终将本手册放在手为了预防人 和财产损坏，请注意相应的指令。指令的标记下存在人 风注存在损坏财产或危害环境的风请注有用的其他信息和提允 3/16/20154:43:35 AboutthisNotethattheEnglishversionofthismanualisthemasterfromwhichtranslationsderive.Incaseofanydiscrepancy,thebindingversionistheEnglishtext.

关于本手请注意，本手册的译文是根据英文版手册翻译而来 如有任Wedo,ofcourse,providesupportincaseoftechnicalproblems.PleasecalldirectlyyourapprovedEMSrepaircenteroryourdealer.Wewishyoulotsof

们将为您提供支持。请直接致电经批准的EMS维修中心或您的经销希望您使用顺利 3/16/20154:43:35 Generalhintsfor General Preparingfortreatment.....................................4Dryingthesterilizedhandpiece.....................4Nozzleinstallationandhandpiece Usage Wearamaskandeye Powersettingair/powderwaterflowrate Positioningofthesalivapumpandthespeedevacuatorsuction Working PrecautionstobetakenattheendoftheRemovingthenozzleandthe Cleaning,disinfectingand Cleaningthehandpiece Cleaningthehandpiecewith CleaningthehandpiecewithEasy Safety Storingthe Product EMS- Technical

治疗的常规提示一般信治疗预备干燥经过灭菌的洁牙手柄喷嘴安装和手柄连接使用须知佩戴面罩和眼睛防护装置治疗11通过功率设置调节空气/粉末和水流速率11牙泵和高速排空吸嘴的放置13操作技15治疗结束时应注意的事项19取下喷嘴和手柄21清洁 和灭菌23清洁牙手柄线23使用针来清洁手持件25使用EasyClean清洁剂来清洁手持件27灭菌3134产品35产品报废36保修36附件�36客户服 37符38技术数据39故障排除41 3/16/20154:43:35 GENERALHINTSFORGeneralAllpatientssufferingfromperiodontaldiseaseandperi-imThissystemisspeciallymendedPeriodontalmaintenanceofdeeppocketupto10mmfollowingPeriodontalbiofilmImntContra-Thetreatmentofdeepperiodontalpocketscancause PleaseapplyappropriaterestrictionsforthetreatmentofriskPregnancy,breastContagiousPatientsundertreatment(radiotherapy,chimiotherapy,

适应症有牙周病和种植体周围炎的所有患本系统尤其在以下情况下推荐使用在初步治疗后的深牙周袋（深达10mm）的牙牙周菌膜的清种植牙的清症深牙周袋的治疗可能导致菌血症。处于以下风险情形的患者进行治时，请采用适当的限制条件心内膜妊娠期 喂养接触性传染免疫缺陷（嗜中性白血球减少症、粒性白细胞缺乏症 、血友病患者正在接受治疗（放射治疗、化疗、抗生素治疗2 3/16/20154:43:39 Theairjetandpowdermaycausebreathingdifficulties.Pleaseapplyappropriaterestrictionsforthetreatmentofriskpatients:Patientssufferingfromchronicbronchitisorasthmamustnotbetreatedunderanycircumstanceswiththisproduct. smaybesensitivetothepowder.Ifreactionsareobserved,stopusingtheproductandcompleyremoveThenozzlecannotbeThesingleusenozzlemustbeusedforonesinglepatientonly.Neverreuseanozzlebecausetreatmentwillbeineffectiveandtheriskofemphysemawouldincrease.TheuseofanyotherpowderthantheEMSpowdersforsubgingivalapplicationwouldreducethenozzle'sservicelife.Asaresultthetreatmentwouldeineffectiveandwouldincreasetheriskofemphysema.FormoredetailsabouthowtousetheAIR-FLOWunitsandtheEMSpowder,pleasereadtheiroperationinstructions.

空气喷射及粉末可能导致呼吸。处于以下风险情形的患者进行治疗时，请采用适当的限制条件：任何情况下均不得使用有这种发病倾向的人可能对牙粉过敏。若出现过敏反应，立即不能对喷嘴进行灭菌处理喷嘴必须只用于一个患者。切勿重新使用其它喷嘴，否则治使用非EMS龈下用牙粉的其它任何牙粉将缩短喷嘴的使 。样，将导致治疗无效并会增加肺气肿的风有关如何使用AIR-FLOW设备和EMS牙粉 详情，请参阅使用说明书3 3/16/20154:43:39 DryingthesterilizedFollowingthesterilization,blowtheinteriorofthehandpiecewithcompressedairtopossible4 3/16/20154:43:39 灭菌后，立即用压缩空气吹干手柄内部。

5 3/16/20154:43:39 NozzleinstallationandhandpieceBeforeeachuse,makesurethenozzleiscorrectlyattached:Thenozzlemustbefullyinserted.Donotusethenozzleincaseofdoubtthatpackagesealwasbroken,orthatpackageorproductisdamaged.6 3/16/20154:43:39 喷嘴安装和手柄每次使用前，务必确保喷嘴已正确连接：喷嘴必须完全插入◦若怀疑包装封条破损，或包装或产品损坏时，切勿使用7 3/16/20154:43:39 USAGEWearamaskandeyeApowderjetaccidentallydirectedintotheeyecancausesevereocularinjury.Thereforeitstronglymendedfor stoweareyeprotectionduringTolimittheriskofbacterialorviralinfectionsandinhalationofpowder,wemendtotheandthehygienisttowearasafetyprotectionThecontactlensesorglassesofthepatientmaygetdirtyduringthetreatment.Wemendtotakethemoff.ThePERIO-FLOWnozzleshouldneverbepointedtowardthepatientbefore,duringandafter8 3/16/20154:43:39 若牙粉意外喷入眼中，可能会导致严重眼损伤。因而，强烈建议所有人在治疗过程均佩戴眼防护装置为了降低细菌 以及吸入牙粉的风险，建议牙医和护士佩戴安全防护面罩治疗过程中，患者 眼镜或眼镜可能会被弄脏。建议摘 眼镜或眼镜在操作之前、期间和之后，PERIO-FLOW喷嘴绝对不要朝向患9 3/16/20154:43:39 Rinsingthepatientmouthbeforetreatmentforatleast30secondswithanantbacterialsolutionwillgreatlypreventbacteriadevelopmentduringthetreatment.ApplicationofVaseline®onpatient'slipswillpreventthemingdryandThecottonrollersstoptheflowofsaliva,partthelipsandprotectthe

患者伤口至少30秒钟，这样可以有效 在患者嘴唇上抹上凡士林将防止嘴唇干裂。棉签可防止唾液流出、分开双唇并保护牙床。 3/16/20154:43:39 Powersettingair/powderandwaterflowrate

通过功率设置调节空气/粉末和水流速 NeverusethePERIO-FLOWhandpiecewithoutwaterflow;thiscouldcauselesionsinthetreatmentarea.Startthetreatmentwithwaterflowrateadjustmentcontrolsetatmediumsetting.Thenadjusttheirrigationtoobtainaflowasrequiredfortreatment.Startthetreatmentwiththepowersettingair/powdercontrolto

没有水流时，切勿使用PERIO-FLOW手柄；否则，可能导致治疗区域局部损伤。水流速率调节控制设置在中档时，开始治疗 然后，调节冲洗法以取治疗所需水流功率设置调节空气/粉末控制在最低档时，开始治疗。之后在治疗期 3/16/20154:43:39 PositioningofthesalivapumpandthehighspeedevacuatorsuctionPositionthesalivapumpsuctionnozzleforasublingualUsethelargenozzleofyourhigh-speedevacuatorofyourdentalunittoremoveair/powdermixtureduringtreatment. 3/16/20154:43:39 牙泵和高速排空吸嘴的放放置牙泵吸嘴以进行舌下抽吸治疗过程中，使用本牙科设备的高速排空装置的大喷嘴清除空气/粉末混合物。 3/16/20154:43:39 WorkingThenozzlelengthenablescleaningpocketsover5mmNevertreatwithPERIO-FLOWthepocketsdowntotheapex.Atleast3mmofbonemustbepresenttopreventtheriskofemphysema.AlwaysuseanevacuatorduringInsertthenozzleintotheperiodontalpocket.Thepenetrationdepthdependsonthepocketdepth.Donot thenozzleintothepocketbecausethiscouldhurtsofttissues. 3/16/20154:43:39 操作技喷嘴长度可实现超过5mm深牙周袋的清洁 必须至少出现3mm的牙骨，以防治疗过程中，务必使用排空装置1�将喷嘴插入至牙周袋。其 深度取决于牙周袋的深度。切勿强行将喷嘴插入牙周 3/16/20154:43:39 5 Whenthenozzleisinsertedinthepocket,pressthepedalofyourdevicefor5seconds.EMSpowder/airmixtureconfinedbyawaterjetissprayedintotheperiodontalpocket.Duetothemechanicalactionoftheair,powderandwaterspray,thesubgingivalbiofilmiseliminatedfromtherootsurface.cethenozzleontheedgeofthesulcusandletthesprayactfor5seconds umoneachsideofthetooth(vestibular,lingual,distal).Carryonthetreatmentwithshorttinyrotarymotionsofthe 3/16/20154:43:39 42�下本设备踏板持续5秒之久。将受喷水限制的EMS牙粉/空气物喷入牙周袋中。因空气、粉末和水喷射时产生的机械作用，龈下菌膜即可从压根表面3�将喷嘴置于沟槽边缘，尽可能在牙齿的所有面上（ 3/16/20154:43:39 ReleasethepedalandwaituntilthesprayRemovethenozzlefromthepocketandrepeattheoperationinthenextpocket.Neversprayoutsideperiodontalpockets.Externaloperationacceleratesnozzlewearandcausesamultidirectionalsprayjetwhichcanbeunpleasantforthepatient.

4�释放脚踏开关，等待，直到喷射停5�从牙周袋上取下喷嘴，在下一个牙周袋中重复上述切勿在牙周袋外面喷射。外部操作可能加速喷嘴磨损，并产生多向喷射，使患者感到不适 3/16/20154:43:39 Precautionstobetakenattheendofthe

治疗结束时应注Immediayaftertreatment,pointthenozzletoasinkandturnoffthedevice.Duringshutoffanairspraywillremoveeventualresiduesofpowderfromtheairchannels.Theautomaticcleaningoftheairsystemisalsoactivatedincaseofpowerfailure.ThisiswhythePERIO-FLOWnozzleshouldneverbepointedtowardthepatientbefore,duringandafteroperation.

关闭过程中，喷射牙粉失效时，空气系统的自动清洁功能也会启动。这就是在操作前、期间和之后，PERIO-FLOW喷嘴绝不可朝向患者的原因所 3/16/20154:43:39 RemovingthenozzleandtheDisconnectthecordandthehandpiecefromtheRemovethenozzleasusermanual. 3/16/20154:43:39 取下喷嘴和手断开手柄线和手柄与本设备的连如图所示取下喷嘴用喷嘴拆除器将喷嘴取下，具体操作请参阅"PERIO-FLOW®喷嘴拆除器"的使用手册 3/16/20154:43:39 CleaningthehandpieceWipethesurfaceofthecordwith70%isopropylalcoholoradisinfectionwipewithprovenFollowcarefullytheinstructionsprovidedbythedisinfectionsolutionmanufacturer. 3/16/20154:43:39 清洁洁牙手柄 3/16/20154:43:39 Cleaningthehandpiecewith Removetheresidualpowderpresentinthetubesbyusingthecleaningneedles.Proceedwithprecautionanddonotuse PleasefollowthemendationsoftheReprocessingInstructionsmanualdeliveredwithyourproductregardingtheproceduresforcleaning,disinfecting,sterilizingandpackingofthecomponents. 3/16/20154:43:39 使用针来清洁手使用清洁针去除管内的残留粉末。清洁过程中一定要 谨慎，不可使用蛮力，因为针很容易破碎。仅可使用制造商所提供的工具。 前使用流 洁牙手 3/16/20154:43:39 CleaningthehandpiecewiththeEasyClean 3/16/20154:43:39 使用EasyCleanEASYCLEAN设计为疏通和辅助清洁EMSAIR-FLOW洁牙手柄 使用EASYCLEAN疏通洁牙手使用装满2ml以上饮用水质量的液体的 取下EASYCLEAN之后，向洁牙手柄内部吹入压缩空气，以去除其中的水分。建议每周或完成15次治疗后进行定期清 3/16/20154:43:39 UncloggingthehandpieceusingtheEASYTogetmore onthepressureuseasmallsyringe(1or2ml)filledwithdrinkwater.InserttheassembledsyringewiththeEASYCLEANintothehandpiecelumina.Pressstronglyifneededandmaintainthepressureuntilthehandpieceisunclogged(itcantake2to5seconds)Thewaterpassingthroughthehandpiecewilldissolvecompleytheremainingpowderinsidetheluminaandensureanoptimalfunction.Afteruncloggingthehandpiece,applytheperiodicalUnclogthehandpiecebefore 3/16/20154:43:39 使用EASYCLEAN疏通洁牙手要获得更大压力，请使用充满饮用水的小号注射器（1或2ml）将装有EASYCLEAN的注射器插入洁牙手柄内腔中 需要）并继续施压，直至洁牙手柄疏通（需要2到5秒）流过洁牙手柄的水将疏通洁牙手柄后，请定期进行清洁请先疏通洁牙手柄，然后 3/16/20154:43:39 Aftersterilizingwithoutasterilizationbag,stainsmayappearontheSystemBox

如果灭菌处理时未使用灭菌包，SystemBox 3/16/20154:43:39 PleasefollowthemendationsoftheReprocessingInstructionsmanualdeliveredwithyourproductregardingtheproceduresforcleaning,disinfecting,sterilizingandpackingofthePuttheaccessoriesinsterilizationbagsorusetheEMSSystemBox.TheSystemBoxallowstheconditioningofthepleaseaskyourdentaldealer.Tomaintainthesterilitywhenstockingtheequipment,youcanputtheSystemBoxinasterilizationbag.the

灭有关组件清洁、灭菌、 和包装的程序，请遵照随产品附带。将附件放在灭菌袋中，或使用EMSSystemBox。SystemBox可提供对附件进行灭菌处理的条件。提供多种配置， 库存设备时，为了保持设备的无菌性，可将SystemBox放入灭菌袋◦如果灭菌处理时未使用灭菌包，SystemBox上可能出现污渍。 3/16/20154:43:39 Dryingandconnectingthesterilized Aftersterilization,moisturemaybepresentinthehandpiece.Blowtheinteriorofthehandpiecewithdrycompressedair.Makesuretheconnectionis 3/16/20154:43:39 烘干并连接已经进行灭菌处理后，洁牙手柄中可能存在潮气。请将干燥的压缩空气吹入洁牙手柄内部。确保连接干燥。 3/16/20154:43:39 SAFETYEMSandthedealerofthisproductacceptnoliabilityfordirectorconsequentialinjuryordamageresultingfromimproperuse,arisinginparticularthroughnon-observanceoftheoperationinstructions,orimproperpreparationandmaintenance.Usefortheintendedpurposeonly:Beforeusingtheproduct,makesurethatyouhavestudiedtheoperationinstructions.Thisalsoappliestoanyequipmentusedwiththisproduct.Failuretoobservetheoperationinstructionsmayresultinthepatientorusersufferingseriousinjuryortheproductbeingdamaged,possiblybeyondrepair.Riskofexplosion:Donotusethisproductinthepresenceofinflbleanaestheticsorgases.Thisproductmustbeusedonlybytrainedand Beforeeachuse,clean,disinfectandsterilizethedifferentpiecesandaccessoriesofthisproduct(nozzlesexcepted).Pleaserefertotheinformationprovidedintheoperationinstructions.Non-sterilepiecesandaccessoriesmaycausebacterialorviralinfections.UseonlythepowdermendedbyEMSforthesubgingivalapplicationwhenthePERIO-FLOWhandpieceisconnectedtotheunit.Anyotherpowdercouldcauseprematurewearofthenozzleandwouldconsequentlyincreasetheriskofemphysemaanddamagetotheunenameleddentine.

EMS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操作、预备和 不当而造成的直接或连带人身 或损坏，概不负责。仅可用于预期目的：使产品之前，请务必先阅读使用说明书的内容。这一点同样适用于配合本产品使用的任何设备。未遵守使用说明可能会对患者或用户造成严重人身 ，或会对产品造成损坏，很可能无法修复。 不要在有易燃麻醉剂或气体的地方使用每次使用前，都应对本产品的各个部件和附件（喷嘴除外）进行清洁、 和灭菌处理。请参阅使用说明书中提供的信息。 灭菌部件和附件可能会造成细菌和 。当PERIO-FLOW手柄连接至本设备时，仅可使用EMS推荐用的牙粉用于龈下。和损害非瓷釉牙质的风险。开始治疗之前，务必检查产品是否损坏。得再使用，必须予以更换。只使用原厂EMS备件和附件。本产品只能由经批准的EMS维修中心进行维修Damagedaccessoriesoradamagedunitmustnotbeusedandmustbereced.UseoriginalEMSsparepartsandaccessoriesonly.HavethisproductexclusivelyrepairedbyanapprovedEMSrepair 3/16/20154:43:39 STORINGTHE Keeptheoriginalpackaginguntiltheproductistobedisposedofpermanently.Youcanuseitforship orstoringatanytime.ShouldyouwishtoputyourproductoutofuseforanextendedofProceedasdescribedinthechapter"Cleaning, disinfectingandPacktheproductandallaccessoriesintheoriginal

如果您希望长时 放闲置产品请按照“清洁 和灭菌”一章中的说明进行操作将产品和所有附件放入原厂包 牙粉不应在邻近热源 Thepowdershouldnotbestoredattheproximityofaheat 3/16/20154:43:39 PRODUCTTheproduct,itsaccessoriesanditspackagingdonotcontainanysubstancesthataredangerousfortheenvironment.Shouldyouwishtodefinitivelydisposetheproduct,pleasecomplywiththeregulationswhichapplyinyourcountry.ThewarrantyisvalidfromthedateofpurchaseofyourproductfortheperiodindicatedintheRegistrationCard.Damagesduetonon-adherencetotheoperationinstructionsorwearofpartsareexcludedfromAccessoriesareavailablefromEMSoranyauthorizeddealers.Pleasecontactyourcustomerservicedirectly.

产品、其附件及包装不含任何对环境有害如果您想彻底将产品报废，请遵照当地 进行处理自 产品之日起，将对产品承担保修责任，保修期为登记卡中说明的年限。由于未遵守使用说明而造成的损坏或零件的正常磨损不在保修附件可以从EMS或任何 的经销商获得。请直接联系您的客户服 3/16/20154:43:39 Shouldyourproductneedadditionalservicingorrepairs,pleasesendittoyourdealerorourapprovedEMSrepaircenter.Inthecaseofnon-authorizedrepairsordamagedduetonon-adherencetotheoperationinstructions,EMSacceptsnoliabilitywhatsoever.Thiswillalsovoidthewarranty.Itisbesttoshipyourproductintheoriginalpackaging.Itprotectsyourproductagainstdamageduringshipment.Beforedispatchingyourproductincludingallaccessories,clean,disinfectandsterilizeasdescribedintheoperationWhensendingyourproductdirectlytotheapprovedEMSrepaircenter,pleaseincludethenameofyourdealer.Thissimplifiesprocessingfor

EMS客户服务如果您的产品需要其他服务或维修，请将产品寄送到您的经销商或经批的EMS维修中心如果擅自维修产品，或因 使用说明而使产品损坏，EMS不承担任何责任。此类行为也将使保修失效。最好采用原包 产品。这样可以防止产品 过程中损坏在寄送产品（包括所有附件）之前，请按照使用说 说明对其进清洁 和灭菌将产品直接寄送到经过批准的EMS维修中心时，请随附经销商名称。这 3/16/20154:43:39 Manufacturer’s制造商标Lot批注意Catalogue类别参Donotre-唯一用Thermal高制造Yearof制造年 Readtheoperation请阅读使用说明Sterilizableatupto135°Cinthe必须在高压灭菌器中以最高135C的温度进行灭CEmarking:Referstodirective93/42EEC,includingEN60601-1andEN60601-1-CE标志：请参阅指令9342EEC，包括EN60601-1和EN60601-1- 3/16/20154:43:39

说EMSEMSSA,CH-1260Nyon,PERIO-+10°Cto30%to75%relativeStorageand-10°Cto10%to95%relativehumidity500hPato1060hPaairpressureEMSSA，CH-1260型PERIO-类别93/42IIa+10℃至+3075和条-10℃至+1095气压500hPa至1060 3/16/20154:43:39 NowatersprayiscomingfromNopowder/airsprayiscomingfromthenozzleandtheWaterleakagebetweencordand

RemovethenozzleandverifythatawaterjetcomesoutfromtheRemoveanyresiduewiththecleaningneedleinbothwater&airCheckthewateradjustmentonyourChecktheconnectionsbetweentheunit,thecordandtheCheckthewaterCheckforpresenceofwateratthecordoutletCheckforpresenceofwateratthesystemconnectoroutletwithoutSendthesystemtoanapprovedEMSrepairRemovethenozzleandverifythepowder/aircomeoutfromRemoveanyresiduewiththecleaningneedleortheEasyCleaninbothwater&airCheckthecompressedairCheckforpresenceofpowder/airatcordoutletportwithoutCheckforpresenceofpowder/airatthesystemconnectoroutletwithoutCheck tyofpowderinyourChangetheSendthesystemtoanapprovedEMSrepairCheckthepositionofthenozzleanditspositionontheCheckforresiduesbetweenthenozzleandtheCheckthatnothingaffectthealignmentoftheChangetheChangetheSendthesystemandthehandpiececordtoancertifiedEMSrepairChecktheconditionofthehandpiececonnec