Instructon Manual Scaler tps 0123 1 Symbols See Secton 2 Safety Important nformaton for users Can be steam-sterlsed n an autoclave Can be thermo-dsnfected CE mark ndcates that the product comples wth the Medcal Devce Drectve REF. SN Reference number Seral number 1 2 3 Intensty Level 1: low (1/3) Level 2: medum (2/3) Level 3: hgh (3/3) Spray Level 1: 20 40 ml Level 2: 41 50 ml Level 3: max. 60 ml 2 Safety 2.1 Descrpton of rsk levels s used for stuatons n whch a lack of care can endanger patents, users or others. s used for stuatons that can lead to serous njury. 2.2 Safety nstructons Please be sure to observe all of the nformaton n your scaler handpece s operatng nstructons. Ensure that the tp, key and handpece are compatble. Combnatons that do not ft can cause damage.
The type of the nstrument s stated on the tp. MK-dent scaler tps are only ntended for the area of use descrbed (see 3.1 Defnton of purpose). Make sure that the scaler tp s correctly postoned each tme you use t. 3 Product descrpton MK-dent scaler tps combned wth an ultrasonc scaler can be used n a very wde range of areas. 3.1 Defnton of purpose Scalng Removng stans and supragngval scale, removng crowns Perodontcs Scalng and perodontal therapy Endodontcs Preparaton of root canals, rnsng root canals, cleanng root canals, compressng gutta-percha Restoraton Mnmally nvasve cavty preparaton For detals see 7. 3.2 Intended use Ths product should be used exclusvely n complance wth ts defned purpose by expert, traned personnel and n accordance wth the specfcatons, notces and warnngs n these Operatng Instructons. Usng the product n any other way can endanger patents, users or others, and s not allowed. You should check t every tme you use t to make sure t s workng properly. Check the condton of the scaler tp usng MK-dent scaler tp testers (ncluded wth every MK-dent scaler handpece and avalable onlne at www.mk-dent.com/download-center/gebrauchsanwesungen). Please refer to the approprate operatng nstructons for nformaton about how to use the scaler handpeces properly. 4 General nformaton Damage to pulp and tooth Too lttle spray water can cause the nstrument to overheat and lead to njury. Set the water quantty for spray coolng to at least 20 ml/mn, unless stated otherwse. Rsk of nfecton for patents and users due to non-sterle nstruments The nstrument and ts accessores must be prepared n accordance wth these nstructons the frst tme they are used, and after every treatment; see Secton 8 Cleanng and dsnfectng n complance wth ISO 17664. Do not use on any metal or ceramc crowns, or prosthetcs, otherwse you may damage them. 5 Gettng started and usng 5.1 Preparng to get started Check that the scaler handpece and accessores are complete and undamaged. To use a tp, refer to the scaler handpece s operatng nstructons. 5.2 Operaton Before begnnng each treatment, rnse the water-carryng systems for at least two mnutes wthout nstruments on. You should also rnse them for 20 to 30 seconds wth the tp attached after each patent. Rnse out the scaler after every scalng procedure for at least 30 seconds, so that you clean any coarse partcles out of the tp and handpece. Then remove the scaler tp. 6 Use MK-dent scaler handpeces are dstngushed by a lateral radus of movement whch allows to treat the patent very gently. To ensure ths remans the case, always hold the nstrument at a tangent and press t sdeways aganst the surface of the tooth. Placng the scaler tp perpendcular to the tooth durng treatment can damage the tooth. 2
6.1 Usng damond-covered scaler tps Damond-covered scaler tps should always be used wth enough water so that they reman cool. Set the water quantty for spray coolng to at least 20 ml/mn. Check the condton of the damond layer before use. A worn damond layer reduces effcency. 7 7.1 Scalng Damond-covered scaler tps should always be used wth enough water so that they reman cool. Set the water quantty for spray coolng to at least 20 ml/mn. Products n ths category: ST01E / ST01ED ST01S / ST01SD Unversal, for removng supragngval calculus. ST03E / ST03ED ST03S / ST03SD ST02E / ST02ED ST02S / ST02SD Unversal, for removng supragngval, nterproxmal calculus. ST04E / ST04ED ST04S / ST04SD For removng coatngs, dental cement and coarse resdue. 7.2 Prosthetcs Products n ths category: ST05E ST05S For removng crowns and brdges. NO NO NO 7.3 Perodontcs Damond-covered scaler tps should always be used wth enough water so that they reman cool. Set the water quantty for spray coolng to at least 20 ml/mn. 3
Products n ths category: ST06E / ST06ED ST06S / ST06SD Precson tp for cleanng and rnsng perodontal pockets. ST07E ST07S Damond-coated precson tp (40µm) for smoothng. YES YES NO ST08E / ST08ED ST08S / ST08SD For meltng gutta-percha (n conjuncton wth an approprate soluton). YES YES NO NO NO NO ST09E ST09S Damond-coated precson tp (40µm) for wdenng the root canal and removng broken fle fragments. YES NO YES ST10E / ST10ED ST10S / ST10SD Cleanng tp for removng shallow calculus. YES YES YES ST11E ST11S Damond-coated tp for removng shallow supragngval calculus. YES YES YES 7.4 Endodontcs Damond-covered scaler tps should always be used wth enough water so that they reman cool. Set the water quantty for spray coolng to at least 20 ml/mn. Products n ths category: YES NO NO ST12E ST12S Endo fle holder wth 120 angle. Recommended for cleanng root canals. For the versatle use of dfferent endo fles wth dameters of 0.7 mm and 0.8 mm. An Endo Torque s needed to attach. YES NO NO ST13E ST13S Endo fle holder wth 95 angle. Recommended for cleanng root canals. For the versatle use of dfferent endo fles wth dameters of 0.7 mm and 0.8 mm. An Endo Torque s needed to attach. YES NO NO ST14E ST14S Endo fle holder wth 180 angle. Recommended for cleanng root canals. For the versatle use of dfferent endo fles wth dameters of 0.7 mm and 0.8 mm. An Endo Torque s needed to attach. 4
ST15E ST15S For removng root treatment resdue durng root treatment. YES YES NO NO NO NO YES NO NO NO NO NO ST16E ST16S Damond-coated precson tp (40µm) for removng excess fll materal durng root treatment. For wdenng and cleanng root canals. ST17E ST17S For removng root treatment resdue durng root treatment. YES NO NO NO NO NO Y YES NO NO NO NO NO Y ST18E ST18S Damond-coated precson tp (40µm) for removng excess fll materal durng root treatment. For wdenng and cleanng root canals. 7.5 Cavty preparaton Damond-covered tps should always be used wth enough water so that they reman cool. Set the water quantty for spray coolng to at least 20 ml/mn. Products n ths category: ST19E ST19S For treatng occlusal cavtes. YES YES NO NO NO NO ST20E ST20S For treatng mesal cavtes. ST21E ST21S For treatng dstal cavtes. ST22E ST22S Instrument wth tp angled 45 to the left. ST23E ST23S Instrument wth tp angled 45 to the rght. EMS and Acteon-Satelec are regstered trademarks. MK-dent has no economc lnks wth the aforementoned companes. 5
8 Cleanng and dsnfectng n complance wth ISO 17664 The scaler handpece and scaler tps, ncludng the MK-dent Prophy Torque and Endo Torque, have to be cleaned and dsnfected after every treatment. 8.1 Preparatons n the place of use Rsk of nfecton through non-sterle nstruments Wear gloves. Clean and dsnfect the nstrument wthn an hour after the treatment. Immedately remove remnants of cement, blood and composte. Take the nstrument for cleanng and dsnfectng when t s dry. 8.2 Cleanng Cleanng n an ultrasonc unt may cause damage Only clean the nstrument as descrbed below. 8.2.1 Manual cleanng Brush the nstrument under runnng water usng a dsposable toothbrush untl you cannot see any more drt. Remove the scaler tp from the handpece usng the Prophy Torque or the endodontc tp usng the Endo Torque, and rnse all the parts under runnng water. Also rnse the spray hole and thread thoroughly. Use a jet needle to clean the spray channel n the scaler tp so as to remove any potental blockages. Place scaler tp and fttng tool nto a cleanng soluton afterwards (dose: 1%, e.g. neodsher Med Clean Forte) and allow to soak for ten mnutes.. After that, rnse the Prophy Torque and scaler tp usng demneralsed water to remove the cleanng soluton. Blow the parts dry usng compressed ar untl no more drops of water are vsble. 8.3 Dsnfecton 8.3.1 Manual dsnfecton Always use dsnfectants whose mcrobologcal effect s guaranteed by the manufacturer (such as VAH/DGHM regstraton or CE labellng). Rnse the handpece and the tp completely and use a spray to rnse any places that are dffcult to get at. Place all of the parts of the dsassembled handpece and the tp wth ts fttng tool nto the approprate alcohol-based dsnfectant (such as 70% sopropyl alcohol). Allow them to soak n the soluton for ten mnutes. After that, rnse all the parts usng demneralsed water to remove the dsnfectng soluton. 8.3.2 Mechancal cleanng and dsnfecton MK-dent recommends thermo-dsnfectors that meet the requrements of EN ISO 15883-1. Cleanng should be done at at least 55 C (131 F) for at least sx mnutes, and dsnfecton at at least 90 C (194 F) for at least fve mnutes (for A0 value > 3000). For cleanng we recommend a mldly alkalne cleanng agent, ph 9 to 11, such as neodsher Med Clean Forte. For detals of valdatng ths process, see 10 Valdatng cleanng and dsnfectng. Place scaler tps nto a seve. If vsble drt remans after treatment n the thermo-dsnfector, then the process must be repeated. The nstrument must be dry and free of resdue before use. Ensure the nstrument s dry after the end of the cycle, otherwse there mght be adverse effects. 8.4 Dryng 8.4.1 Manual dryng Blow dry the nsde and outsde of the scaler tps and fttng tool usng compressed ar untl no more drops of water are vsble. 8.4.2 Mechancal dryng Dryng should normally be part of your thermo-dsnfector s cleanng cycle. Please refer to your thermo-dsnfector s operatng nstructons. If the nstrument stll shows sgns of mosture after the end of the cycle, blow t usng compressed ar untl t s completely dry. 9 Sterlsaton The sterlsaton bag has to be bg enough for the nstrument so that the packagng s not under tenson. Packagng for tems beng sterlsed has to meet the applcable standards of qualty and use and must be suted to the sterlsaton process. Seal the parts nto a sterlsaton package. 6
9.1 Sterlsaton n an autoclave n complance wth EN 13060/ISO 17665-1 Mosture causes contact corroson Damage to product. Remove the nstrument from the autoclave mmedately after the sterlsaton cycle. The medcal product s resstant to temperatures up to 135 C (275 F). Use the followng sterlsaton procedure: Autoclave wth fractonal pre-vacuum (recommended): mn. 4 mnutes at mn. 132 C (270 F) Refer to the manufacturer s operatng nstructons. 10 Valdatng cleanng and dsnfectng Mechancal cleanng and dsnfectng was valdated usng a WD BHT INNOVA M3 devce and Dr. Wegert neodsher Med Clean Forte cleanng agent. Settngs: - 1 mnute pre-rnsng at 30 C (86 F) - 6 mnutes cleanng at 55 C (131 F) wth a dose of 0.5% neodsher Med Clean Forte - 1 mnute neutralsaton - 1 mnute post-rnsng - 5 mnutes dsnfectng at 90 C (194 F) Mechancal dsnfecton was valdated usng 70% sopropyl alcohol and 10 mnutes of soakng. Sterlsaton was valdated usng a W&H LISA 517 unt wth fractonal pre-vacuum at 132 C (270 F) for 4 mnutes. Please note that the treatment process used at your practce also needs to be valdated. 11 Storage Store treated nstruments n a dry, dark, cool room protected from dust and, as far as possble, from bactera. Please note the expry date of sterlsed tems. 12 Tools Prophy Torque fttng tool SC21KEY Endo Torque fttng tool SC22KEY MANUFACTURER MK-dent GmbH Mare-Cure-Str. 2 D-22941 Bargtehede Tel.: +49 (0)4532 40049 0 Fax: +49 (0)4532 40049 10 Emal: nfo@mk-dent.com Web: www.mk-dent.com Fle: Rev: GA_MK_SC_SH_002_EN.ndd A/05_2017