mk-dent HE11 User manual

Instrucon manual
HE11, HE12, HE14, HE15L, HE16L, HE17, HE18
HB12, HB14, HB15L, HB16L
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1 Explanaon of symbols
See chapter 2. Safety
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Important informaon for the user
Product can be sterilized in a steam sterilizer (Autoclave)
Can be used in thermal disinfectors
CE-mark – Conrms that this product fullls all requirements for medical products
REF Reference number
SN Serial number
2 Safety
2.1 Descripon of danger levels
CAUTION
CAUTION
CAUTION is used if a deciency in adequate care may result in an endangering of the paent, the user or others.
WARNING
WARNING
WARNING is used if improper use may result in serious injuries.
2.2 Safety notes
WARNING
WARNING
Risk of injury for the paent and the operator
Concerning damages like irregular running noise, irregular vibraons, an unspecic rise in temperature and/or other defects.
→ Stop operang immediately and contact our service.
WARNING
WARNING
Risk of infecon
In case of an injury of the ssue in the oral area, do not proceed to work with air-operated instruments because of a high risk of
an infecon.

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WARNING
WARNING
Burns due to an increased heat of the head of the instrument
Burns in the oral area may occur due to an increased heat of the head of the instrument.
CAUTION
CAUTION
Accelerated deterioration and dysfunctions due to long term non-usage
→ Before storage, clean, maintain and dry the instrument according to the norm. Store in the
original packing, dry and dustproof.
We recommend an annual check-up and maintenance of the enre spindle system by MK-dent or by MK-dent authorized personnel.
3 Product descripon
This manual can be used for the following MK-dent products:
Turbines of the Eco Line series
2-hole connecon 4-hole connecon 5-hole connecon
Standard head Small head Standard head Small head Mini head Standard head Small head
HE11 - HE12, HE17 HE18 HE14 HE15L HE16L
Turbines of the Basic Line series
4-hole connecon 5-hole connecon
Standard head Mini head Standard head Mini head
HB12 HB14 HB15L HB16L
3.1 Intended purpose
This medical product may only be used in a dental surgery, especially for the following purposes:
Removal of decayed material, preparaons of cavies and crowns, removal of llings.
3.2 Use according to regulaons
This product may only be used for the intended purposes, executed by professionally trained personnel.
The indicaons and warnings in this manual must be considered. This also includes the observing of the processing (see chapter 5 Processing
according to ISO 17664 ) and the valid naonal health and safety regulaons. Any other use may result in an endangering of the paent, the
operator or others and is strictly prohibited. Before each applicaon, the funconality of the instrument must be tested.
3.3 Technical specicaons
Driving pressure (bar) 2.2 - 2.5
Pressure of spray water (bar) 0.8 - 2.5
Pressure of spray air (bar) 1.0 - 4.0
Air consumpon (Nl/min) 40
RPM Standard head/Small head/Mini head 300 000 - 340 000/380 000 - 420 000/380 000 - 420 000
Recommended press-on force (N) 2 - 3
Spray water consumpon (ml/min) according to EN ISO 14457 > 50
Operang noise dB(A) Standard head/Small head/Mini head 65/70/70
3.4 Transport and storage requirements
CAUTION
CAUTION
Dysfunction of the instrument while operating after an overcooled storage
→ Heavily cooled instruments must be warmed to room temperature prior to operang.
For transportaon and storage, please consider the following:
Temperature -20 °C - +70 °C (-4 °F - +158 °F)
Relave humidity 5% - 95%, non-condensing
Air pressure 700 hPa - 1060 hPa (10 psi - 15 psi)
Protect this medical instrument from moisture!
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4 Pung into service and operaon
WARNING
WARNING
Risk of infection for patients and operator due to non-sterile instruments
→ Before the rst and aer each further use the instrument and the aachments must be processed and sterilized as dened in
chapter 5 Processing according to ISO 17664.
WARNING
WARNING
Risk of infections for others at waste disposal
→ Before waste disposal, this medical product has to be processed according to instructions and must at least be sterilized.
CAUTION
CAUTION
Dysfuncons and/or risk of an infecon caused by moist and contaminated compressed air and by contaminated cooling water
→ This product may only be operated with CE-certified dental units or with others certified by actual national guidelines and
with a corresponding supply of water and compressed air according to the valid norms of dental care.
4.1 Preparaon for use
4.1.1 Pressure test
Place the tesng pressure gauge between the coupler and the instrument to test the following pressures (see chapter 3.3 Technical specicaons):
- Driving pressure
- Pressure of returning air
- Pressure of spray water
- Pressure of spray air
4.1.2 Tesng the quanty of water
WARNING
WARNING
Damage to pulpal or teeth
A too low quanty of spray water may result in an overheang of the head of the instrument and can lead to corresponding
injuries.
→ Regulate the quantity of the spray water to a minimum of 50 cm3/min.
Check the quanty of water with a measuring cup. Check the spray water canals. In case of a too low water supply or a clogged nozzle, clean the
nozzle with the enclosed pin. See also chapter 7.1 Cleaning of the spray nozzle.
4.2 Operaon
Prior to each working day, all systems with water supply have to be rinsed out for at least 2 minutes, before aaching an instrument. Aer
each treatment another rinsing process has to be performed for 20 to 30 seconds, especially concerning products that rewind/retract.
4.3 Aaching the instrument to the coupler
WARNING
WARNING
Dysfuncons due to a decoupling of the instrument while operang
An instrument that is not correctly aached to the coupler may loosen while operang.
→ Prior to each use check if the instrument and the coupler are correctly attached by slightly pulling at the instrument.
 Place the instrument exactly on the tubing coupler and turn in the direcon of the arrow unl it ts properly.
 Check the proper ng by slightly pulling the instrument in an upward moon.
 To detach the instrument hold the tubing coupler and turn the coupler against the direcon of the arrow.
4.4 Inseron of rotang instruments
WARNING
WARNING
Risk of injury for the patient due to a decoupling of the rotating instrument
→ Check the holding force of the spindle by pulling at the bur aer each inseron of burs.
WARNING
WARNING
Risk of injury for the paent and possible damages of the instrument
Use of other instruments than those menoned above.
→ Only use rotating instruments that fulfill the requirements mentioned above.
→ Consider the manual for the intended use of the rotang instrument.
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WARNING
WARNING
Risk of injury due to the use of worn out rotang instruments
Rotang instruments can fall out while operang and thus injure the paent.
→ Do not use any rotang instruments with a worn out sha.
WARNING
WARNING
Risk of injury for the user due to rotang instruments
Cuts and resulng infecons may occur due to incorrect use.
→ Always use gloves or a finger protection.
Only use rotang instruments made of steel or carbide metal that fulll the EN ISO 3823-1 requirements and also the following criteria:
Diameter of the sha 1.591 to 1.599 mm
Length of the sha (standard head/small head/mini head) max. 25/21/19 mm
Full insert lenth of the sha (standard head/small head/mini head) min. 12/11/9 mm
Diameter of the cuer max. 2 mm
 Press the push-buon of the back cap with your thumb and simultaneously insert the rotang instrument into
the spindle as far as it will go.
 Check the proper ng by slightly pulling at the bur.
 Check the holding force of the spindle at least weekly by using the measurement tool RT1020 or another device according to ISO 8325. The
holding force of the spindle must not be less than 2.5 kg. At a holding force of less than 3 kg we recommend to replace the cartridge.
4.5 Removal of rotang instruments
WARNING
WARNING
Risk of injury due to rotang instruments
Cuts and damages in the spindle system may occur.
→ Never touch the rotating instrument.
→ Do not press the push button of the back cap while operating.
→ Remove the rotating instrument after each operation to prevent any kind of injuries and infections during storage.
 Aer the rotang instrument has stopped moving, press the push buon of the back cap with your thumb while
simultaneously pulling out the rotang instrument.
5 Processing according to ISO 17664
5.1 Processing at the locaon of use
WARNING
WARNING
Risk of infection due to non-sterile instruments.
→ Always wear gloves.
 Process the instrument within one hour aer each treatment in order to prevent piling.
 Immediately remove any debris of cement, blood or composite.
 Ensure a dry transport of the instrument to the place of processing.
 Do not put the instrument in any kind of soluon.
5.2 Cleaning
WARNING
WARNING
Dysfunctions due to cleanings in an ultrasonic bath
→ Only clean the instrument as described below.
5.2.1 Manual pre-cleaning
CAUTION
CAUTION
Risk of infection due to multiple uses of dental brushes
→ To prevent cross infections always use a new dental brush for each instrument.
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CAUTION
CAUTION
Insufficient cleaning of the surface and the water- and air pipes
→ In order to ensure a successful cleaning a thorough manual pre-cleaning, even with the small brush, must be done.
Tools:
- Drinkable water 30 °C ± 5 °C (86 °F ± 10 °F)
- Brush or so tooth brush
- Dental brush
- 50 ml syringe without cannula
 To pre-clean the instrument place it under running water and carefully brush debris completely o the surface by using one of the tools
menoned above.
 To pre-clean the spindle, please insert the dental brush in the spindle opening. Carefully remove any residue and debris by circular moons
with the brush.
 Repeat the process several mes and each me clean the dental brush with water.
 To pre-clean the water- and air pipes place the syringe at the lower end of the handpiece and rinse the cavies at least 5 mes.
5.2.2 Cleaning the visible end of the glass rod of dental turbines with light
CAUTION
CAUTION
Risk of scratches due to careless treatment
Defects of the glass rod result in a lower light quality.
→ Clean the glass rod with great care.
 Clean the visible part of the glass rod with warm water and so cloth.
 Dry with air or with a new so 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 repair
service immediately.
5.3 Disinfecon
CAUTION
CAUTION
The use of disinfecng baths and/or of chlorinated disinfectants may lead to defects and dysfuncons of the instrument.
→ Only clean and disinfect the instrument in a thermal disinfector.
5.3.1 Manual disinfecon of the surface
Only use disinfectants whose microbiological eecveness is ensured by the manufacturer (e.g. VAH/DGHM-regis-traon and CE-mark).
Concerning the material compability, only disinfectants free of aldehyde and based on alcohol may be used.
 Apply the disinfectant to a cloth and wipe the instrument clean.
 Consider the reacng me that is set by the manufacturer of the disinfectant.
 Follow the manual for the disinfectant.
5.3.2 Mechanical cleaning and disinfecon of the interior and the exterior
MK-dent recommends thermal disinfectors that fulll the EN ISO 15883-1 requirements and are approved by the manufacturer for the
straight- and contra angle, as well as for high speed handpieces. The cleaning should be carried out at a minimum of 55°C (131°F) and for
at least 5 minutes, the disinfecon at a minimum of 90°C (194°F) and for at least 5 minutes (for an A0-value > 3,000). For the cleaning a
mild alkaline cleaning agent with a pH of 9 to 11 is recommended, like e.g. Neodisher® MediClean Forte. For the validaon of the process
see chapter 6.2 Validaon of the processing.
 For the internal cleaning the adaptors specied by the manufacturer must be used.
 Repeat the process, if visible contaminaons sll exist aer the treatment in a thermal disinfector.
 Before use the instrument must be dry and free of residues.
 To prevent any kind of impairments of the instrument, make sure aer every cycle that the instrument is dry on the inside and the outside.
 Directly aerwards use the MK-dent Premium Service Oil to lubricate the instrument.
5.4 Process of drying
5.4.1 Manual drying
 Blow on the instrument with compressed air from the inside and the outside unl no visible drops are le.
5.4.2 Mechanical drying
The drying process normally is part of the cleaning process of your thermal disinfector. Please follow the instrucons for your thermal disinfector.
 In case of moisture remaining on the instrument aer the cleaning process, blow with compressed air unl completely dry.

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5.5 Maintenance with the MK-dent Premium Service Oil LU1011
5.5.1 Cleaning and maintaining the spindle
Before each sterilizaon, please follow these steps in the declared order.
 Please insert the enclosed dental brush into the spindle and carefully remove any kind of debris or residue by circular movements with the
brush. Repeat this process several mes and clean the brush with water.
 Place the enclosed lubricaon tool LT1014 on the MK-dent Premium Service Oil can and spray for approximately 2 seconds.
If very unclean, repeat this process several mes.
5.5.2 Lubricaon of the canal for drive air
MK-dent recommends lubricang and maintaining the instrument aer each mechanical cleaning and before each sterilizaon process.
 Insert the lubricaon tool into the lower end of the instrument as shown above and spray into the canal for drive air for approximately 2 seconds.
 Connect the instrument to your treatment unit and let it run for 15 to 20 seconds, so that the surplus lubricant can escape from the instrument.
6 Sterilizaon
The sterilizaon bag has to be big enough for the instrument so that the instrument ts without stretching the bag. Concerning quality
and applicaon, the bag has to fulll all the valid norms and has to be suitable for the sterilizaon process.
 Shrink-wrap each instrument individually into a sterilizaon bag.
6.1 Sterilizaon with a steam sterilizer (Autoclave) according to EN 13060/ISO 17665-1
CAUTION
CAUTION
Damages due to inappropriate maintenance or service may result in dysfunctions and/or deterioration.
Reduced lifetime of the product
→ Lubricate the instrument with the MK-dent Premium Service Oil before each sterilizaon.
CAUTION
CAUTION
Contact corrosion caused by moisture
Damages of the product
→After sterilization, immediately remove the instrument from the autoclave.
This medical product has a temperature resistance of up to max. 135°C (275°F).
Only apply the following sterilizaon process:
- Autoclave with a triple pre-vacuum (recommended): minimum of 5 minutes at a minimum of 134°C (273°F)
 Pay close aenon to the manufacturer´s instrucon.
6.2 Validaon of the processing
The validaon of the cleaning and of the disinfecon was carried out with the device Miele® G 7835 in the programme Vario TD with the
cleanser Neodisher® MediClean Forte.
Adjustment:
- Pre-rinsing for 1 minute
- Cleaning at 55°C (131°F) for 5 minutes with a dosage of 0.5% Neodisher® MediClean Forte
- Neutralizaon
- Washing down
- Disinfecon at 90°C (194°F) for 5 minutes
The sterilizaon was validated with the device Tunauer® EHS 3870 in a fraconal pre-vacuum process at 134°C (273°F) for 5 minutes.
Please note, that the reprocessing procedure performed in your dental oce must be validated also.
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2-hole
connecon
4-hole
connecon
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For more informaon on the enre preparaon process download our MK-dent Processing Guide for High- & Low Speed Handpieces
from our website www.mk-dent.com/downloadcenter.
6.3 Maintenance & service
CAUTION
CAUTION
Inappropriate maintenance or service may result in dysfunctions and/or deterioration.
→ Always perform proper maintenance and service.
7 Removal of dysfuncons
7.1 Cleaning of the spray nozzle
WARNING
WARNING
Damage to pulpal or teeth
A too low quanty of spray water may result in an overheang of the instrument and can lead to resulng injuries.
→ Check the canals of the spray water regularly and, in case of blocking, clean the spray nozzle with the enclosed pin.
 Carefully remove any blockages of the canals of the spray water with the enclosed pin.
7.2 Storage
 Store the cleaned and sterilized instruments in a dry, dark and cool place, sheltered from dust and germs.
 Please pay aenon to the date of expiry of the sterilizaon liquid.
8 Tools & spare parts
Replacement turbine Eco Line
Standard head: HE11, HE12, HE15L, HE17
Small head: HE16L, HE18
Mini head: HE14
Replacement turbine Basic Line Standard head: HB12, HB15L
Mini head: HB14, HB16L
Nozzle pin AC0001
Dental brush for the maintenance of the spindle AC0003
Holding-force measurement tool for the spindle RT1020
Lubricaon tool for the maintenance of the rotor LT1012
Lubricaon tool for the maintenance of the spindle LT1014
Premium Service Oil LU1011
Premium Service Oil for KaVo® QUATTROCARE LU1022
KaVo® is a registered trademark. MK-dent does not have any economical connecon to the company menoned above.
9 Warranes
MK-dent provides the end user a warranty for proper funcon, immaculate material and workmanship for a period of 12 months (Basic Line)/18
months (Eco Line) aer purchasing. Relevant for this is the invoice date.
In case of jused complaints MK-dent carries out a free repair or a possible free replacement. This will be decided by MK-dent.
Other claims of any kind, in parcular damage compensaon are excluded. In the event of default, gross negligence or intent, this shall only apply
unless there are compelling legal regulaons.
MK-dent is not liable for defects and their consequences that have arisen whose arising may be due to natural wear, improper handling, improper
cleaning, or maintenance, non-compliance with operang or manual instrucons, calcinaon or corrosion, contaminated air and water supply or
chemical or electrical inuences that are unusual or not permied according to MK-dent’s instrucon for use or to other manufacturer‘s
instrucons.
The warranty does usually not cover lamps, light conductors made of glass bers, glassware, rubber parts and the color fastness of plasc parts.
All liability is excluded if defects or their consequences arise because of intervenons or modicaons on the product by the end user or by a third
party not authorized by MK-dent.
Warranty claims will only be accepted if the product is submied with a proof of purchase in the form of an invoice or a copy of the delivery note.
Dealer, purchase date, model and serial number must be clearly visible.
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MANUFACTURER
MK-dent GmbH
Marie-Curie-Str. 2
D-22941 Bargteheide
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Web: www.mk-dent.com
IFU_MK_HS_H_ECO_BASIC_03_EN_RevB