Instructon manual LBH11, LBH11P 0123 1 Explanaton of symbols See chapter 2. Safety Important nformaton for the user Product can be sterlzed n a steam sterlzer (Autoclave) Can be used n thermal dsnfectors CE-mark Confrms that ths product fulflls all requrements for medcal products REF SN Reference number Seral number 2 Safety 2.1 Descrpton of danger levels s used f a defcency n adequate care may result n an endangerng of the patent, the user or others. s used f mproper use may result n serous njures. 2.2 Safety notes Rsk of njury for the patent and the operator Concernng damages lke rregular runnng nose, rregular vbratons, an unspecfc rse n temperature and/or other defects. Stop operatng mmedately and contact our servce. Rsk of nfecton In case of an njury of the tssue n the oral area, do not proceed to work wth ar-operated nstruments because of a hgh rsk of an nfecton.
Burns due to an ncreased heat of the head of the nstrument Burns n the oral area may occur due to an ncreased heat of the head of the nstrument. Accelerated deteroraton and dysfunctons due to long term non-usage Before storage, clean, mantan and dry the nstrument accordng to the norm. Store n the orgnal packng, dry and dustproof. We recommend an annual check-up and mantenance of the entre spndle system by MK-dent or by MK-dent authorzed personnel. 3 Product descrpton Ths manual can be used for the followng MK-dent products: Contra angle heads of the Basc Lne seres LBH11 LBH11P 3.1 Intended purpose Ths medcal product may only be used n combnaton wth the sutable contra angle body and for the treatment of patents n dental surgeres. 3.2 Use accordng to regulatons Ths product may only be used for the ntended purposes, executed by professonally traned personnel. The ndcatons and warnngs n ths manual must be consdered. Ths also ncludes the observng of the processng (see chapter 5 Processng accordng to ISO 17664) and the vald natonal health and safety regulatons. Any other use may result n an endangerng of the patent, the operator or others and s strctly prohbted. Before each applcaton, the perfect functonalty of the nstrument must be tested. 3.3 Techncal specfcatons LBH11 LBH11P Transmsson/reducton 1:1 1:1 Max. speed 20 000 mn -1 5 000 mn -1 Sutable bodes MK-dent LB11, LB41, contra angle bodes of the NSK EX seres MK-dent LB11, LB41, contra angle bodes of the NSK EX seres Sutable burs/attachments Contra angle burs Snap-on prophy cups Push-button yes no NSK s a regstered trademark. MK-dent does not have any economcal connecton to the company mentoned above. 3.4 Transport and storage requrements Dysfuncton of the nstrument whle operatng after an overcooled storage Heavly cooled nstruments must be warmed to room temperature pror to operatng. For transportaton and storage, please consder the followng: Temperature Relatve humdty Ar pressure -20 C - +70 C (-4 F - +158 F) 5% - 95%, non-condensng 700 hpa - 1060 hpa (10 ps - 15 ps) Protect ths medcal nstrument from mosture! 4 Puttng nto servce and operaton Rsk of nfecton for patents and operator due to non-sterle nstruments Before the frst and after each further use the nstrument must be processed and sterlzed as defned n chapter 5 Processng accordng to ISO 17664. Rsk of nfectons for others at waste dsposal Before waste dsposal, ths medcal product has to be processed accordng to nstructons and must at least be sterlzed. 2
Dysfunctons and/or rsk of an nfecton caused by most and contamnated compressed ar and by contamnated coolng water Ths product may only be operated wth CE-certfed dental unts or wth others certfed by actual natonal gudelnes and wth a correspondng supply of water and compressed ar accordng to the vald norms of dental care. 4.1 Attachng and removng the contra angle head Rsk of njury for the patent due to a separatng of the contra angle head An ncorrectly attached head may loosenwhle operatng. Pror to each treatment check f the head s frmly attached and f the couplng nut s completely tghtened. Head Hold the head as shown n the fgure and nsert t. Tghten up the couplng nut n drecton of the arrow. To remove the head unscrew the couplng nut n opposte drecton and take off the head. Couplng nut 4.2 Inserton and removal of rotatng nstruments (LBH11) Rsk of njury for the patent due to a fallng out of the rotatng nstrument After each nserton of burs check the holdng force of the spndle by pullng on the bur. Rsk of njury due to the use of worn out rotatng nstruments Rotatng nstruments can fall out whle operatng and thus njure the patent. Do not use any rotatng nstruments wth a worn out shaft. Rsk of njury for the user due to rotatng nstruments Cuts and resultng nfectons may occur. Always use gloves or a fnger protecton. Danger due to a defectve spndle In case of a defectve spndle, the bur may fall out and cause njures. Check the correct attachng of the spndle by slghtly pullng at the bur. Use gloves or fnger protecton for nsertons and removals of the spndle to prevent njures and nfectons. Only use rotatng nstruments made of steel or carbde metal, that fulfll the EN ISO 1797-1 requrements and also fulfll these crtera: Dameter of the shaft Full length of the shaft 2.334 to 2.350 mm max. 22 mm Press the push-button of the back cap and nsert the rotatng nstrument nto the spndle wth turnng movements. Afterwards release the push-button. Check the proper fttng by slghtly pullng at the bur. To remove the head let the bur come to a full stop. By pressng thepush-button on the back of the head the bur can be released and then be removed. 4.3 Attachng of a snap-on prophy cup (LBH11P) Put the snap-on prophy cup on the bracket at the front of the head. 3
5 Processng accordng to ISO 17664 5.1 Processng at the locaton of use Rsk of nfecton due to non-sterle nstruments. Always wear gloves. Process the nstrument wthn one hour after each treatment n order to prevent plng. Immedately remove any debrs of cement, blood or composte. Ensure a dry transport of the nstrument to the place of processng. Do not put the nstrument n any knd of soluton. 5.2 Cleanng Dysfunctons due to cleanngs n an ultrasonc bath Only clean the nstrument as descrbed below. 5.2.1 Manual pre-cleanng Rsk of nfecton due to multple uses of dental brushes To prevent cross nfectons always use a new dental brush for each nstrument. Insuffcent cleanng of the surface and the water- and ar ppes In order to ensure a successful cleanng a thorough manual pre-cleanng, even wth the small brush, must be done. Tools: - Drnkable water 30 C ± 5 C (86 F ± 10 F) - Brush or soft tooth brush - Dental brush - 50 ml syrnge wthout cannula To pre-clean the nstrument place t under runnng water and carefully brush debrs completely off the surface by usng one of the tools mentoned above. To pre-clean the spndle, please nsert the dental brush n the spndle openng. Carefully remove any resdue and debrs by crcular motons wth the brush. Repeat the process several tmes and each tme clean the dental brush wth water. To pre-clean the water- and ar ppes place the syrnge at the lower end of the handpece and rnse the cavtes at least 5 tmes. 5.3 Dsnfecton The use of dsnfectng baths and/or of chlornated dsnfectants may lead to defects and dysfunctons of the nstrument. Only clean and dsnfect the nstrument n a thermal dsnfector. 5.3.1 Manual dsnfecton of the surface Only use dsnfectants whose mcrobologcal effectveness s ensured by the manufacturer (e.g. VAH/DGHM-regs-traton and CE-mark). Concernng the materal compatblty, only dsnfectants free of aldehyde and based on alcohol may be used. Apply the dsnfectant to a cloth and wpe the nstrument clean. Consder the reactng tme that s set by the manufacturer of the dsnfectant. Follow the manual for the dsnfectant. 5.3.2 Mechancal cleanng and dsnfecton of the nteror and the exteror MK-dent recommends thermal dsnfectors that fulfll the EN ISO 15883-1 requrements and are approved by the manufacturer for the straght- and contra angle, as well as for hgh speed handpeces. The cleanng should be carred out at a mnmum of 55 C (131 F) and for at least 5 mnutes, the dsnfecton at a mnmum of 90 C (194 F) and for at least 5 mnutes (for an A0-value > 3,000). For the cleanng a mld alkalne cleanng agent wth a ph of 9 to 11 s recommended, lke e.g. Neodsher MedClean Forte. For the valdaton of the process see chapter 6.2 Valdaton of the processng. For the nternal cleanng the adaptors specfed by the manufacturer must be used. Repeat the process, f vsble contamnatons stll exst after the treatment n a thermal dsnfector. Before use the nstrument must be dry and free of resdues. To prevent any knd of mparments of the nstrument, make sure after every cycle that the nstrument s dry on the nsde and the outsde. Drectly afterwards use the MK-dent Premum Servce Ol to lubrcate the nstrument. 4
5.4 Process of dryng 5.4.1 Manual dryng Blow on the nstrument wth compressed ar from the nsde and the outsde untl no vsble drops are left. 5.4.2 Mechancal dryng The dryng process normally s part of the cleanng process of your thermal dsnfector. Please follow the nstructons for your thermal dsnfector. In case of mosture remanng on the nstrument after the cleanng process, blow wth compressed ar untl completely dry. 5.5 Mantenance wth the MK-dent Premum Servce Ol LU1011 MK-dent recommends lubrcatng and mantanng the nstrument after each mechancal cleanng and before each sterlzaton process. For the mantenance of the cartrdge screw the enclosed lubrcaton tool onto the lubrcaton can. Insert the lubrcaton tool nto the lower end of the nstrument and spray nto the canal for drve ar for approxmately 2 seconds untl the ol evades from the head of the contra angle handpece. Plug the nstrument onto your treatment unt and let t run for 15 to 20 seconds so that the surplus lubrcant can escape from the nstrument. 6 Sterlzaton The sterlzaton bag has to be bg enough for the nstrument so that the nstrument fts wthout stretchng the bag. Concernng qualty and applcaton, the bag has to fulfll all the vald norms and has to be sutable for the sterlzaton process. Shrnk-wrap each nstrument ndvdually nto a sterlzaton bag. 6.1 Sterlzaton wth a steam sterlzer (Autoclave) accordng to EN 13060/ISO 17665-1 Damages due to napproprate mantenance or servce may result n dysfunctons and/or deteroraton. Reduced lfetme of the product Lubrcate the nstrument wth the MK-dent Premum Servce Ol before each sterlzaton. Contact corroson caused by mosture Damages of the product After sterlzaton, mmedately remove the nstrument from the autoclave. Ths medcal product has a temperature resstance of up to max. 135 C (275 F). Only apply the followng sterlzaton process: - Autoclave wth a trple pre-vacuum (recommended): mnmum of 5 mnutes at a mnmum of 134 C (273 F) Pay close attenton to the manufacturer s nstructon. 6.2 Valdaton of the processng The valdaton of the cleanng and of the dsnfecton was carred out wth the devce Mele G 7835 n the programme Varo TD wth the cleanser Neodsher MedClean Forte. Adjustment: - Pre-rnsng for 1 mnute - Cleanng at 55 C (131 F) for 5 mnutes wth a dosage of 0.5% Neodsher MedClean Forte - Neutralzaton - Washng down - Dsnfecton at 90 C (194 F) for 5 mnutes The sterlzaton was valdated wth the devce Tuttnauer EHS 3870 n a fractonal pre-vacuum process at 134 C (273 F) for 5 mnutes. Please note, that the reprocessng procedure performed n your dental offce must be valdated also. For more nformaton on the entre preparaton process download our MK-dent Processng Gude for Hgh- & Low Speed Handpeces from our webste www.mk-dent.com/downloadcenter. 6.3 Mantenance & servce Inapproprate mantenance or servce may result n dysfunctons and/or deteroraton. Always perform proper mantenance and servce. 5
7 Storage Store the cleaned and sterlzed nstruments n a dry, dark and cool place, sheltered from dust and germs. Please pay attenton to the date of expry of the sterlzaton lqud. 8 Tools & spare parts Contra angle head LBH11 LBH11P Lubrcaton tool LT1013 Premum Servce Ol LU1011 Premum Servce Ol for KaVo QUATTROCARE LU1022 9 Warrantes KaVo s a regstered trademark. MK-dent does not have any economcal connecton to the company mentoned above. MK-dent provdes the end user a warranty for proper functon, mmaculate materal and workmanshp for the followng perods of warranty after purchasng: Basc Lne: 12 months Relevant for ths s the nvoce date. In case of justfed complants MK-dent carres out a free repar or a possble free replacement. Ths wll be decded by MK-dent. Other clams of any knd, n partcular damage compensaton are excluded. In the event of default, gross neglgence or ntent, ths shall only apply unless there are compellng legal regulatons. MK-dent s not lable for defects and ther consequences that have arsen whose arsng may be due to natural wear, mproper handlng, mproper cleanng, or mantenance, non-complance wth operatng or manual nstructons, calcnaton or corroson, contamnated ar and water supply or chemcal or electrcal nfluences that are unusual or not permtted accordng to MK-dent s nstructon for use or to other manufacturer s nstructons. The warranty does usually not cover lamps, lght conductors made of glass fbers, glassware, rubber parts and the color fastness of plastc parts. All lablty s excluded f defects or ther consequences arse because of nterventons or modfcatons on the product by the end user or by a thrd party not authorzed by MK-dent. Warranty clams wll only be accepted f the product s submtted wth a proof of purchase n the form of an nvoce or a copy of the delvery note. Dealer, purchase date, model and seral number must be clearly vsble. MANUFACTURER MK-dent GmbH Mare-Cure-Str. 2 D-22941 Bargtehede Phone: +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_LS_KO_002_EN.ndd B/03_2017 6