mk-dent LBH11P User manual

Instrucon manual
LB41/11P
0123
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 dust-
proof.
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:
Contra angle handpieces of the Basic Line series
LB41/11P (composed of contra angle head LBH11P and contra angle body LB41)
3.1 Intended purpose
This medical product may only be used for the treatment of paents in dental surgeries.
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 perfect
funconality of the instrument must be tested.
3.3 Technical specicaons
LB41
Transmission/reducon 4:1
Max. speed 5 000 min-1
Max. drive speed 20 000 min-1
Label green ring
Suitable contra angle heads MK-dent LBH11, LBH11P, heads of the NSK® EX series
Motor connecon according to ISO 3964/DIN 13940 yes
LBH11P
Transmission/reducon 4:1
Max. speed 5 000 min-1
Max. drive speed 5 000 min-1
Suitable contra angle bodies MK-dent LB11, LB41, contra angle bodies of the
NSK® EX series
Suitable burs Snap-on prophy cups
NSK® is a registered trademark. MK-dent does not have any economical connecon to the company menoned above.
3.4 Transport and storage requirements
CAUTION
CAUTION
Dysfunction of the instrument after a 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 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
→ 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 compressed air according to the valid norms of dental care.
4.1 Aaching and removing the head of the instrument
WARNING
WARNING
Risk of injury for the paent due to a separang of the head of the instrument
An incorrectly aached head may loosen or even fall out.
→ Prior to each treatment check if the head is rmly aached and if the coupling nut is completely ghtened.
 Hold the head as shown in the gure and insert it.
 Tighten up the coupling nut in direcon of the arrow.
 To remove the head unscrew the coupling nut in opposite direction and take off the head.
4.2 Aaching of a snap-on prophy cup
 Put the snap-on prophy cup on the bracket at the front of the head.
4.3 Aaching the instrument to the motor
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.
CAUTION
CAUTION
Damages due to an inseron or a removal of the instrument, while the motor is rotang
Damages to the collector of the motor
→ Never unplug or plug the instrument to the motor, when the motor is rotang!
 Place the instrument exactly on the motor and turn to the back unl the connecon clicks in place.
 Check the proper ng of the instrument on the motor by slightly pulling at the instrument.
 For removal, hold the motor in one hand, while pulling the instrument upwards in a turning moon with the other hand.
Coupling nut
Head

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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.
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 enclosed dental brush in the spindle opening. Carefully loosen/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.
5.3 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.

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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.
5.5 Maintenance with the MK-dent Premium Service Oil LU1011
MK-dent recommends lubricang and maintaining the instrument aer each mechanical cleaning and before each sterilizaon process.
 For the maintenance of the cartridge screw the enclosed lubricaon tool onto the lubricaon can.
 Insert the lubricaon tool into the lower end of the instrument and spray into the canal for drive air for approximately 2 seconds unl the oil
evades the contra angle head.
 Plug the instrument onto 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.
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.
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6.3 Maintenance & service
CAUTION
CAUTION
Inappropriate maintenance or service may result in dysfunctions and/or deterioration.
→ Always perform proper maintenance and service.
7 Storage
 Store the cleaned and sterilized instrument 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
Contra angle body LB41
Contra angle head LBH11P
Lubricaon tool LT1013
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 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 aer MK-dent’s instrucon for use or other manufacturer‘s instrucons are not permied.
The warranty does not usually 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 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_LS_CAH_BASIC_03_EN_RevB