Instruction manual REF HE11, HE12, HE14, HE15L, HE16L, HE17, HE18 HB12, HB14, HB15L, HB16L. 1 Explanation of symbols
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1 Instructon manual HE11, HE12, HE14, HE15L, HE16L, HE17, HE18 HB12, HB14, HB15L, HB16L 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.
2 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: Turbnes of the Eco Lne seres 2-hole connecton 4-hole connecton 5-hole connecton Standard head Small head Standard head Small head Mn head Standard head Small head HE11 - HE12, HE17 HE18 HE14 HE15L HE16L Turbnes of the Basc Lne seres 4-hole connecton 5-hole connecton Standard head Mn head Standard head Mn head HB12 HB14 HB15L HB16L 3.1 Intended purpose Ths medcal product may only be used n a dental surgery, especally for the followng purposes: Removal of decayed materal, preparatons of cavtes and crowns, removal of fllngs. 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 ) 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 functonalty of the nstrument must be tested. 3.3 Techncal specfcatons Drvng pressure (bar) Pressure of spray water (bar) Pressure of spray ar (bar) Ar consumpton (Nl/mn) 40 RPM Standard head/small head/mn head / / Recommended press-on force (N) 2-3 Spray water consumpton (ml/mn) accordng to EN ISO > 50 Operatng nose db(a) Standard head/small head/mn head 65/70/ 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 C (-4 F F) 5% - 95%, non-condensng 700 hpa hpa (10 ps - 15 ps) Protect ths medcal nstrument from mosture!
3 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 and the attachments must be processed and sterlzed as defned n chapter 5 Processng accordng to ISO 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. 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 Preparaton for use Pressure test Place the testng pressure gauge between the coupler and the nstrument to test the followng pressures (see chapter 3.3 Techncal specfcatons): - Drvng pressure - Pressure of returnng ar - Pressure of spray water - Pressure of spray ar Testng the quantty of water Damage to pulpal or teeth A too low quantty of spray water may result n an overheatng of the head of the nstrument and can lead to correspondng njures. Regulate the quantty of the spray water to a mnmum of 50 cm 3 /mn. Check the quantty of water wth a measurng cup. Check the spray water canals. In case of a too low water supply or a clogged nozzle, clean the nozzle wth the enclosed pn. See also chapter 7.1 Cleanng of the spray nozzle. 4.2 Operaton Pror to each workng day, all systems wth water supply have to be rnsed out for at least 2 mnutes, before attachng an nstrument. After each treatment another rnsng process has to be performed for 20 to 30 seconds, especally concernng products that rewnd/retract. 4.3 Attachng the nstrument to the coupler Dysfunctons due to a decouplng of the nstrument whle operatng An nstrument that s not correctly attached to the coupler may loosen whle operatng. Pror to each use check f the nstrument and the coupler are correctly attached by slghtly pullng at the nstrument. Place the nstrument exactly on the tubng coupler and turn n the drecton of the arrow untl t fts properly. Check the proper fttng by slghtly pullng the nstrument n an upward moton. To detach the nstrument hold the tubng coupler and turn the coupler aganst the drecton of the arrow. 4.4 Inserton of rotatng nstruments Rsk of njury for the patent due to a decouplng of the rotatng nstrument Check the holdng force of the spndle by pullng at the bur after each nserton of burs. Rsk of njury for the patent and possble damages of the nstrument Use of other nstruments than those mentoned above. Only use rotatng nstruments that fulfll the requrements mentoned above. Consder the manual for the ntended use of the rotatng nstrument.
4 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 due to ncorrect use. Always use gloves or a fnger protecton. Only use rotatng nstruments made of steel or carbde metal that fulfll the EN ISO requrements and also the followng crtera: Dameter of the shaft Length of the shaft (standard head/small head/mn head) Full nsert lenth of the shaft (standard head/small head/mn head) Dameter of the cutter to mm max. 25/21/19 mm mn. 12/11/9 mm max. 2 mm Press the push-button of the back cap wth your thumb and smultaneously nsert the rotatng nstrument nto the spndle as far as t wll go. Check the proper fttng by slghtly pullng at the bur. Check the holdng force of the spndle at least weekly by usng the measurement tool RT1020 or another devce accordng to ISO The holdng force of the spndle must not be less than 2.5 kg. At a holdng force of less than 3 kg we recommend to replace the cartrdge. 4.5 Removal of rotatng nstruments Rsk of njury due to rotatng nstruments Cuts and damages n the spndle system may occur. Never touch the rotatng nstrument. Do not press the push button of the back cap whle operatng. Remove the rotatng nstrument after each operaton to prevent any knd of njures and nfectons durng storage. After the rotatng nstrument has stopped movng, press the push button of the back cap wth your thumb whle smultaneously pullng out the rotatng nstrument. 5 Processng accordng to ISO 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 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.
5 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 Cleanng the vsble end of the glass rod of dental turbnes wth lght Rsk of scratches due to careless treatment Defects of the glass rod result n a lower lght qualty. Clean the glass rod wth great care. Clean the vsble part of the glass rod wth warm water and soft cloth. Dry wth ar or wth a new soft cloth. Pre-check the glass rod before each use. In case of a damage of the glass rod do not operate and contact your dealer or the MK-dent s repar servce mmedately. 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 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 Mechancal cleanng and dsnfecton of the nteror and the exteror MK-dent recommends thermal dsnfectors that fulfll the EN ISO 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. 5.4 Process of dryng Manual dryng Blow on the nstrument wth compressed ar from the nsde and the outsde untl no vsble drops are left 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.
6 5.5 Mantenance wth the MK-dent Premum Servce Ol LU Cleanng and mantanng the spndle Before each sterlzaton, please follow these steps n the declared order. Please nsert the enclosed dental brush nto the spndle and carefully remove any knd of debrs or resdue by crcular movements wth the brush. Repeat ths process several tmes and clean the brush wth water. Place the enclosed lubrcaton tool LT1014 on the MK-dent Premum Servce Ol can and spray for approxmately 2 seconds. If very unclean, repeat ths process several tmes Lubrcaton of the canal for drve ar MK-dent recommends lubrcatng and mantanng the nstrument after each mechancal cleanng and before each sterlzaton process. 2-hole connecton 4-hole connecton Insert the lubrcaton tool nto the lower end of the nstrument as shown above and spray nto the canal for drve ar for approxmately 2 seconds. Connect the nstrument to 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 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.
7 6.3 Mantenance & servce Inapproprate mantenance or servce may result n dysfunctons and/or deteroraton. Always perform proper mantenance and servce. 7 Removal of dysfunctons 7.1 Cleanng of the spray nozzle Damage to pulpal or teeth A too low quantty of spray water may result n an overheatng of the nstrument and can lead to resultng njures. Check the canals of the spray water regularly and, n case of blockng, clean the spray nozzle wth the enclosed pn. Carefully remove any blockages of the canals of the spray water wth the enclosed pn. 7.2 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 Replacement turbne Eco Lne Replacement turbne Basc Lne Nozzle pn Dental brush for the mantenance of the spndle Holdng-force measurement tool for the spndle Lubrcaton tool for the mantenance of the rotor Lubrcaton tool for the mantenance of the spndle Premum Servce Ol Premum Servce Ol for KaVo QUATTROCARE 9 Warrantes Standard head: HE11, HE12, HE15L, HE17 Small head: HE16L, HE18 Mn head: HE14 Standard head: HB12, HB15L Mn head: HB14, HB16L AC0001 AC0003 RT1020 LT1012 LT1014 LU1011 LU1022 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 a perod of 12 months after purchasng. 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.
8 Manufacturer MK-dent GmbH Echenweg 7b Bargtehede, Germany Tel. +49 (0) Fax +49 (0) Emal: Rev. B/02_2016 Fle: IM_HS_EcoBasc_1_EN_A4.ndd
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