KaVo MASTERmatic LUX M25 L User manual

Instructions for use
MASTERmatic LUX M25 L - 1.009.3630
MASTERmatic LUX M05 L - 1.009.3640

Distribution:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Phone: [phone]
Fax: [phone]
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com

Instructions for use MASTERmatic LUX M25 L - 1.009.3630, MASTERmatic LUX M05 L - 1.009.3640
Table of contents
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Table of contents
1 User instructions ............................................................................................................... 4
2 Safety................................................................................................................................. 7
2.1 Infection hazard ............................................................................................................ 7
2.2 Improper use ................................................................................................................ 7
2.3 Technical condition ........................................................................................................ 7
2.4 Accessories and combination with other equipment........................................................... 8
2.5 Qualification of personnel ............................................................................................... 8
2.6 Service and repair ......................................................................................................... 9
3 Description of the product................................................................................................. 10
3.1 Intended use................................................................................................................. 10
3.2 Technical Specifications.................................................................................................. 11
3.3 Transportation and storage conditions ............................................................................. 11
4 Startup and shut down...................................................................................................... 13
4.1 Checking the amount of water ........................................................................................ 13
5 Operation........................................................................................................................... 15
5.1 Attaching the medical device .......................................................................................... 15
5.2 Removing the medical device.......................................................................................... 16
5.3 Inserting the dental bur.................................................................................................. 16
5.4 Removing the dental bur ................................................................................................ 17
6 Checking for malfunctions and troubleshooting ............................................................... 18
6.1 Checking for malfunctions .............................................................................................. 18
6.2 Troubleshooting............................................................................................................. 18
6.2.1 Replacing the O-rings on the motor coupling ....................................................... 18
6.2.2 Changing the water filter................................................................................... 19
7 Reprocessing steps in accordance with ISO 17664 .......................................................... 20
7.1 Preparations at the site of use......................................................................................... 20
7.2 Manual Reprocessing ..................................................................................................... 20
7.2.1 Manual external cleaning................................................................................... 20
7.2.2 Manual internal cleaning.................................................................................... 20
7.2.3 Manual external disinfection .............................................................................. 21
7.2.4 Manual internal disinfection ............................................................................... 21
7.2.5 Manual drying .................................................................................................. 21
7.3 Automated reprocessing................................................................................................. 22
7.3.1 Automated internal and external cleaning and internal and external disinfection...... 22
7.3.2 Automated drying............................................................................................. 22
7.4 Care products and systems - Servicing ............................................................................ 23
7.4.1 Servicing with KaVo Spray................................................................................. 23
7.4.2 Servicing with KaVo QUATTROcare PLUS ............................................................ 23
7.5 Packaging ..................................................................................................................... 24
7.6 Sterilisation................................................................................................................... 24
7.7 Storage ........................................................................................................................ 25
8 Optional aids and consumables......................................................................................... 26
9 Terms and conditions of warranty .................................................................................... 27

Instructions for use MASTERmatic LUX M25 L - 1.009.3630, MASTERmatic LUX M05 L - 1.009.3640
1 User instructions
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1 User instructions
Dear user,
Congratulations on purchasing this KaVo quality product. By following the notes
below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
All other trademarks are property of their respective owners.
KaVo Technical Service
Please direct all questions regarding the product, service and maintenance to
the KaVo Technical Service:
Toll-free: 1-888-KAVOUSA (888-528-6872)
Email: [e-mail]
Please refer to the serial number of the product in all inquiries.
KaVo Repair Service
For repairs, please contact the KaVo Repair Service. For scheduling or if you
have any questions, please contact:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Toll-free Direct Customer Service: 1-888-KAVOUSA (888-528-6872)
Email: [e-mail]
www.kavo.com
Target group
The instructions for use are intended for medical professionals, in particular
dentists and dental practice personnel.
The section on startup is also intended for the service staff.
General marks and symbols
See Chapter on User Instructions/Hazard Levels
Important information for users and service technicians
Action request
Sterilisation parameters
▪ Steriliser with Dynamic-Air-Removal (pre-vacuum) method:
– 3 minutes at 135oC (275 oF)
– Drying time: 16 min.
▪ Steriliser with gravity displacement method:
– 10 minutes at 135oC (275 oF)
– Drying time: 30 min.
▪ Steriliser with gravity displacement method:
– 60 minutes at 121 o (250 oF)
– Drying time: 15 min.
Thermodisinfectable

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1 User instructions
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Information on the packaging
Material number
Serial number
Manufacturer
Note: Please note accompanying documents
Follow the electronic instructions for use
HIBC Code
CE mark for medical devices
Medical device, labelling of medical devices
EAC conformity mark (Eurasian Conformity)
Transportation and storage conditions
(temperature range)
Transportation and storage conditions
(air pressure)
Transportation and storage conditions
(Humidity)
Protect from moisture (Keep dry)
Protect from impact
Original language German
Hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and material damage. The warning notes are designated as
shown below:
HAZARD
In cases which – if not prevented – directly lead to death or severe injury.
WARNING
In cases which – if not prevented – can lead to death or severe injury.

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1 User instructions
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CAUTION
In cases which – if not prevented – can lead to minor or moderate injury.
CAUTION
In cases which – if not prevented – can lead to material damage.

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2 Safety | 2.1 Infection hazard
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2 Safety
NOTE
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are an integral part of the product and must be read
carefully prior to use and must be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
2.1 Infection hazard
Patients, users or third parties could be infected by contaminated medical
devices.
4Take suitable personal protective measures.
4Follow the instructions for use of the components.
4Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
4Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
4If you deviate from this validated procedure, make sure that the repro-
cessing procedure is effective.
4Reprocess the product and accessories appropriately before disposal.
4In the case of injury to soft tissue, do not continue treatment in the oral
cavity with instruments driven by compressed air.
4Use gloves or a finger guard when you test, insert and remove the dental
bur.
2.2 Improper use
Because the operation with an electric motor involves a higher torque, patients,
users and other people can suffer injuries and serious burns if an instrument is
damaged or used improperly.
4Check the technical condition before each use.
Also refer to:
2.3 Technical condition,Page7
4Never press the push-button during operation of the device.
4Never use the instrument to keep the cheek, tongue or lip at a distance.
4Never touch soft tissue with the handpiece head or instrument cover.
4Do not use the medical device as a light probe.
4Use an appropriate light probe for illumination of the oral cavity or site of
preparation.
4After treatment, place the medical device properly in the cradle without the
tool.
4Do not allow the medical device to rotate at eye level.
During the preparation of abutments, heat transmission can cause thermal
damage to the jawbone.
4During the preparation of abutments, make sure that the preparation times
are short and that there is sufficient cooling.
2.3 Technical condition
If damaged, the device or components could injure patients, users and third
parties.

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2 Safety | 2.4 Accessories and combination with other equipment
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4Only operate devices or components if they show no signs of damage on the
outside.
4Check to make sure that the device is working properly and is in satisfactory
condition before each use.
4Have parts with sites of breakage or surface changes checked by the service
personnel.
4If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
▪ Dental bur is not seated firmly in the handpiece
To ensure optimum function and to prevent property damage, please comply
with the following instructions:
4Service the medical device regularly with care products and systems as de-
scribed in the instructions for use.
4The device should be reprocessed and stored in a dry location, according to
instructions, if it is not to be used for an extended period of time.
Device running hot
High motor torque can lead to severe burn injuries.
4Service motors regularly.
4Do no use any damaged motors.
4Do not use motors for unauthorised purposes.
2.4 Accessories and combination with other equipment
Use of non-authorised accessories or non-authorised modifications of the device
could lead to injury.
4Only use accessories that have been approved for combination with the
product by the manufacturer.
4Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
4Use original KaVo spare parts only.
The lack of control equipment for changing the speed range and the direction of
rotation can lead to injury.
4Control equipment for changing the speed and the direction of rotation must
be present.
4The medical device may only be combined with a treatment centre / control
unit released by KaVo.
4Comply with the Instructions for Use of the treatment centre / control unit.
2.5 Qualification of personnel
Application of the product by users without the appropriate medical training
could injure patients, users or third parties.
4Make sure that the user has read and fully comprehends the instructions for
use.
4Make sure that the user has read and comprehends the national and re-
gional regulations.
4The device may be used only if the user has completed the appropriate
medical training.

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2.6 Service and repair
Repairs, servicing and safety checks may only be performed by trained service
personnel. The following persons are authorised to do this:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorised dealers after the appropriate product
training
Observe all the following items during servicing work:
4Have the service and testing tasks carried out according to the Medical
Device Operator Ordinance.
4After servicing, interventions on and repairs of the device and before re-use,
have the service personnel perform safety checks on the device.
4Following expiry of the warranty, have the tool holding system checked
once a year.
4KaVo recommends specifying in-house service intervals where the medical
device is brought to a professional shop for cleaning, servicing and a func-
tion check. Define the service interval depending on the frequency of use.
As a result of the use of NON-KaVo original spare parts during the repair, parts
such as covers may become undone and injure the patient, user or other
people. This may result in aspiration, swallowing of parts and possibly even a
risk of suffocation.
4Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
NOTE
If a repair is done with NON-KaVo original spare parts, this may constitute a
product modification that leads to the loss of CE conformity. In the event of
damage, the responsibility is with the service company or the operator.
The introduction of a modified product in the market, in which the reasonable
suspicion exists to endanger the safety and health of patients or users, is pro-
hibited by Medical Device Law §4, Abs.1 No. 1 and therefore requires its own
conformity check.

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3 Description of the product | 3.1 Intended use
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3 Description of the product
The electrical-driven MASTERmatic handpieces are dental handpieces in accord-
ance with 21 CFR § 872.4200 (dental handpieces and accessories) designed for
use by a trained professional in the field of general dentistry only.
The devices are electrically driven handpieces that are reusable and ergonomic-
ally shaped, and are provided with a fiber optic light system. The dental hand-
pieces can be sterilised in a steam steriliser (autoclave). MASTERmatic hand-
pieces equipped with a handpiece connector in accordance with ISO 3964 are
connected to a treatment unit by means of a hose and the electrical motor and
receive the energy for the gear, cooling water and air for conservative dental
treatment as well as the light for illumination of the operation area through cor-
responding output openings. Burs in accordance with ISO 1797-1 must be used
with the MASTERmatic handpieces. Based on the INTRAmatic connection that
meets the ISO 3964 standard, the MASTERmatic handpieces fit with any elec-
trical dental motor which is produced in accordance to this standard. The MAS-
TERmatic handpieces interact with the patient through a rotating bur with the
patient teeth according to the intended use.
MASTERmatic Contra-angle handpiece M05 L (Mat. no. 1.009.3640)
MASTERmatic Contra-angle handpiece M25 L (Mat. no. 1.009.3630)
3.1 Intended use
Indications for use:
The MASTERmatic LUX M25 L and MASTERmatic LUX M05 L are intended for
the removal of carious material, reduction of hard tooth structure, cavity and
crown preparations, removal of fillings, processing and finishing of tooth prepar-
ations and restorations, and for polishing teeth. They may be used by trained
professionals in general dentistry exclusively.

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3 Description of the product | 3.2 Technical Specifications
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CAUTION
US Federal law restricts this device to sale by or on the order of a
health care professional / dentist.
For dental use only.
Proper use:
According to these regulations, this product may only be used for the described
application by a properly trained user. You need to comply with the following:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these Instructions for use
According to these regulations, the user is required:
▪ to only use equipment that is operating correctly
▪ to comply with the specified intended use
▪ to protect him or herself, the patient and third parties from hazards
▪ to prevent contamination from the product
3.2 Technical Specifications
Drive speed max. 40,000 rpm
Speed transmission 1 : 5
Identification 1 red ring
Spray water pressure 0.8 to 2.0 bar (12 to 29 psi)
Spray air pressure 1.0 to 2.0 bar (15 to 29 psi)
Spray air flow rate min. 1.5 Nl/min (at 2 bar)
Cooling air flow 5.5 to 9.5 Nl/min
Pushbutton chuck Ø 1.6mm
Insert Dental burs and diamond grinders in
accordance with ISO 1797 type 3
Can be attached to All INTRA (LUX) motors and motors
with a connector in accordance with
ISO 3964
3.3 Transportation and storage conditions
4Do not store in a refrigerated environment.
Temperature: -20°C to +70°C (-4°F to +158°F)
Relative humidity: 5% RH to 95% RH absence of condensation

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Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture (Keep dry)

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4 Startup and shut down | 4.1 Checking the amount of water
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4 Startup and shut down
WARNING
Hazard from contaminated products.
Infection hazard to the dentist and patient.
4Prior to initial startup and after each use, reprocess the product and ac-
cessories.
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
4Reprocess the product and accessories before disposal.
Also refer to:
7 Reprocessing steps in accordance with ISO 17664,Page20
Currently applicable packaging law
Dispose of and recycle the packaging appropriately in accordance with current
packaging law, employing waste management / recycling companies. Comply
with the comprehensive return system. KaVo has had its packaging licensed for
this purpose. Please comply with the regional public waste-disposal system.
CAUTION
Damage from soiled and moist cooling air/compressed air.
Contaminated and moist cooling air can cause malfunctions.
4Make sure that the supply of cooling air is dry, clean and uncontaminated
according to ISO 7494-2.
4.1 Checking the amount of water
CAUTION
Overheating of the tooth due to insufficient amount of cooling water.
Insufficient spray water can cause the medical device to overheat and damage
the pulp and tooth.
4Adjust the water flow for the spray cooling to a minimum of 50 mL/min (3.1
inch3).
4Check the spray water channels and if necessary clean the spray nozzles
with the nozzle needle (Mat. no. 0.410.0921).
4Check water filter and replace, if necessary.

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4 Startup and shut down | 4.1 Checking the amount of water
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5 Operation | 5.1 Attaching the medical device
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5 Operation
WARNING
Rotating dental bur.
Cuts, infection and burn injury.
4Never push the press-button while the dental bur is rotating.
4Do not touch the dental bur while it is rotating.
4Never touch soft tissue with the handpiece head or instrument cover.
4Remove the dental bur from the handpiece after treatment to avoid injury
and infection during storage.
CAUTION
Heat transmission during the preparation of abutments.
Thermal damage to the jawbone.
4During the preparation of abutments, make sure that the preparation times
are short and that there is sufficient cooling.
NOTE
At the beginning of each workday, the water-conducting systems should be
rinsed for at least 2 minutes (without transmission handpieces being at-
tached) and if there is a risk of contamination from reflux or back suction, the
system may also need to be rinsed for 20 to 30 seconds after each patient.
5.1 Attaching the medical device
WARNING
Detaching the medical device during treatment.
A medical device that is not properly locked can detach from the coupling dur-
ing treatment.
4Before each use, check if the medical device is securely locked onto the
coupling.
CAUTION
Connection to the drive motor.
Straight or contra-angle handpiece jams.
4Operate the straight or contra-angle handpiece only with the chuck being
closed.
CAUTION
Removing and attaching the straight or contra-angle handpiece while
the drive motor is rotating.
Damage to the catch pin.
4Never attach or remove the straight or contra-angle handpiece while the
drive motor is rotating.
CAUTION
Pressing the foot switch while attaching or detaching the medical
device.
Property damage to the medical device.
4Do not connect or remove the medical device while pressing the foot switch.

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5 Operation | 5.2 Removing the medical device
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4Lightly spray O-rings on the motor coupling with KaVo Spray.
4Place the medical device on the motor coupling and lock it into place.
4Pull on the medical device to make sure that it is securely affixed to the
coupling.
5.2 Removing the medical device
NOTE
Do not pull the medical device off the motor coupling while holding it by the
instrument head.
4Unlock the medical device from the motor coupling by twisting it slightly and
then pulling it along its axis.
5.3 Inserting the dental bur
NOTE
Only use carbide burs or diamond grinders that comply with ISO 1797 type 3,
are made of steel or hard metal and meet the following criteria:
- Shaft diameter: 1.59 to 1.60 mm (0.0626 in to 0.0629 in)
- Blade diameter: max. 2mm (0.0787 in)
- Overall length M25 L: max. 25mm
- Overall length M05 L: max. 19mm
- Shaft clamping length M25 L: at least 11 mm
- Shaft clamping length M05 L: at least 9 mm
WARNING
Use of unapproved dental burs.
Injury to the patient or damage to the medical device.
4Comply with the instructions for use and the intended use of the dental bur.
4Only use dental burs that do not deviate from the specified data.
CAUTION
Do not use damaged dental burs.
Risk of injury from swallowing a dental bur that falls out.
4Do not use damaged dental burs.
4Do not use dental burs that have been hit.
4Do not use dental burs with adherent soiling.
4Do not use visibly imbalanced dental burs.
CAUTION
Contaminated, sharp-edged dental bur.
Infections or cuts.
4Use gloves or a finger guard when you test, insert and remove the dental
bur.

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5 Operation | 5.4 Removing the dental bur
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CAUTION
Dental bur with damaged, worn or deformed shafts.
Injury hazard, dental bur may fall out during treatment.
4Never use dental burs with damaged, worn or deformed shafts.
CAUTION
Defective chuck system.
Injury hazard, dental bur may fall out during treatment.
4Pull on the dental bur to check if the chuck system works properly and if the
dental bur is firmly clamped.
CAUTION
Dental bur with damaged, worn or deformed shafts.
Material damage to the chuck system, dental bur is difficult or impossible to re-
move from the chuck system.
4Never use dental burs with damaged, worn or deformed shafts.
CAUTION
Dental bur shaft slips inside the chuck due to excessive speed of the
dental bur or abrupt engagement of the dental bur.
Material damage to dental bur shaft and chuck system, reduction of the service
life of dental bur and chuck system.
4Do not operate the dental bur at a higher speed than recommended by the
manufacturer.
4Firmly press the push-button with your thumb and, simultaneously, always
insert the dental bur until it hits the end stop.
4Check if the dental bur is seated securely by pulling on it.
5.4 Removing the dental bur
WARNING
Rotating dental bur.
Cuts, infection and burn injury.
4Never push the press-button while the dental bur is rotating.
4Do not touch the dental bur while it is rotating.
4Never touch soft tissue with the handpiece head or instrument cover.
4Remove the dental bur from the handpiece after treatment to avoid injury
and infection during storage.
CAUTION
Damage to the chucking system.
Material damage.
4Never push the press-button while the dental bur is rotating.
4After the dental bur has stopped rotating, firmly press the push-button
down with your thumb and simultaneously remove the dental bur.

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6 Checking for malfunctions and troubleshooting | 6.1 Checking for malfunctions
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6 Checking for malfunctions and troubleshooting
6.1 Checking for malfunctions
CAUTION
Overheating of the device.
Burns or product damage from overheating.
4If the device overheats, stop working and have the service personnel repair
the device.
CAUTION
Missing or damaged O-rings.
Malfunction and premature failure.
4Make sure that all O-rings are on the coupling and are undamaged.
4If the medical device overheats while idling, check the cooling air flow.
4If the medical device overheats when exposed to load, the medical device
needs to be serviced.
4When the speed drops or is uneven, the medical device needs to be ser-
viced.
4If there is no O-ring on the motor coupling, replace the O-ring.
Also refer to:
Instructions for use of motor
6.2 Troubleshooting
WARNING
Repair WITHOUT using KaVo original spare parts.
Parts such as the cover can come loose and cause injury. Aspiration, swallowing
of parts and danger of suffocation.
4Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
NOTE
If a repair is done with NON-KaVo original spare parts, this may constitute a
product modification that leads to the loss of CE conformity. In the event of
damage, the responsibility is with the service company or the operator.
The introduction of a modified product in the market, in which the reasonable
suspicion exists to endanger the safety and health of patients or users, is pro-
hibited by Medical Device Law §4, Abs.1 No. 1 and therefore requires its own
conformity check.
6.2.1 Replacing the O-rings on the motor coupling
CAUTION
Improper care of the O-rings.
Malfunction or complete failure.
4Do not use Vaseline or other grease or oil.

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6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting
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NOTE
The O-rings on the coupling may only be lubricated with a cotton ball wetted
with KaVo Spray.
4Press the O-ring between your fingers to form a loop.
4Push the O-ring to the front, and remove it.
4Insert new O-rings into the recesses and spray them with KaVo Spray.
6.2.2 Changing the water filter
WARNING
Hazard from contaminated products.
Infection hazard to the dentist and patient.
4Prior to initial startup and after each use, reprocess the product and ac-
cessories.
CAUTION
Overheating of the tooth due to insufficient amount of cooling water.
Insufficient spray water can cause the medical device to overheat and damage
the pulp and tooth.
4Check water filter and replace, if necessary.
4Check the spray water channels and if necessary clean the spray nozzles
with the nozzle needle (Mat. no. 0.410.0921).
4Unscrew the filter with the wrench (Mat. no. 1.002.0321) and take it out.
4Insert a new filter (Mat. no. 1.002.0271) and screw it in with the wrench.

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7 Reprocessing steps in accordance with ISO 17664
7.1 Preparations at the site of use
WARNING
Hazard from contaminated products.
Contaminated products are associated with an infection hazard.
4Take suitable personal protective measures.
WARNING
Sharp dental bur in the medical device.
Injury hazard from sharp and/or pointed dental bur.
4Remove the dental bur.
4Reprocess the medical device right after treatment.
4To minimise the risk of infection during reprocessing, always wear protect-
ive gloves.
4Remove the dental bur from the medical device.
4Remove all residual cement, composite or blood immediately.
4Do not place in solutions or similar substances.
7.2 Manual Reprocessing
WARNING
Sharp dental bur in the medical device.
Injury hazard from sharp and/or pointed dental bur.
4Remove the dental bur.
CAUTION
Never reprocess this medical device in an ultrasonic cleaner.
Malfunction and material damage.
4Reprocess in a washer disinfector or by hand only.
7.2.1 Manual external cleaning
Accessories required:
▪ Tap water
▪ Brush, e.g. medium-hard toothbrush
4Brush off under flowing tap water.
7.2.2 Manual internal cleaning
This product is not designed for manual internal cleaning.
For effective reprocessing, the inside of the device must be subjected to auto-
mated cleaning in a cleaning and disinfection unit in accordance with ISO
15883-1.