KaVo MASTERmatic LUX M10 L User manual

Instructions for use
MASTERmatic LUX M10 L - 1.009.3570

Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Phone [phone]
Fax [phone]
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com

Table of contents
1User instructions............................................................................................................................................... 5
2Safety............................................................................................................................................................... 6
2.1 Description of safety instructions.............................................................................................................. 6
2.2 Safety instructions.................................................................................................................................... 6
3Product description........................................................................................................................................... 8
3.1 Purpose – Intended use............................................................................................................................ 8
3.2 Technical Specifications........................................................................................................................... 9
3.3 Transportation and storage conditions..................................................................................................... 9
4Start up and shut down................................................................................................................................... 10
4.1 Check the amount of water..................................................................................................................... 10
5Operation........................................................................................................................................................ 11
5.1 Attach the medical device....................................................................................................................... 11
5.2 Remove the medical device.................................................................................................................... 11
5.3 Insert the handpiece or contra-angle handpiece drill bit......................................................................... 11
5.4 Remove the handpiece or contra-angle handpiece drill bit..................................................................... 12
5.5 Conversion for contra-angle handpiece drill bit...................................................................................... 12
6Troubleshooting.............................................................................................................................................. 14
6.1 Check for malfunctions........................................................................................................................... 14
6.2 Troubleshooting...................................................................................................................................... 14
6.2.1 Replacing the O-rings................................................................................................................ 14
6.2.2 Cleaning the spray nozzle......................................................................................................... 14
7Reprocessing steps in accordance with ISO 17664....................................................................................... 16
7.1 Preparations at the site of use................................................................................................................ 16
7.2 Cleaning.................................................................................................................................................. 16
7.2.1 Manual cleaning - external........................................................................................................ 16
7.2.2 Automated external cleaning..................................................................................................... 16
7.2.3 Manual cleaning - internal......................................................................................................... 16
7.2.4 Automated internal cleaning...................................................................................................... 17
7.3 Disinfection............................................................................................................................................. 17
7.3.1 Manual disinfection - external.................................................................................................... 18
7.3.2 Manual disinfection - internal..................................................................................................... 18
7.3.3 Machine disinfection - external and internal.............................................................................. 18
7.4 Drying..................................................................................................................................................... 18
7.5 Care products and systems - Servicing.................................................................................................. 19
7.5.1 Care with KaVo Spray............................................................................................................... 19
7.5.2 Care with the KaVo SPRAYrotor............................................................................................... 19
7.5.3 Servicing with KaVo QUATTROcare 2104 / 2104A.................................................................. 20
7.5.4 Servicing with KaVo QUATTROcare PLUS 2124 A.................................................................. 20
7.5.5 Servicing with KaVo QUATTROcare CLEAN 2140 A................................................................ 21
7.6 Packaging............................................................................................................................................... 22
7.7 Sterilisation............................................................................................................................................. 22
7.8 Storage................................................................................................................................................... 22
8Tools and consumables.................................................................................................................................. 23
Instructions for use MASTERmatic LUX M10 L - 1.009.3570
Table of contents
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9Warranty terms and conditions....................................................................................................................... 24
Instructions for use MASTERmatic LUX M10 L - 1.009.3570
Table of contents
4 / 26

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
1 User instructions |
1 User instructions
Dear User
Congratulations on purchasing this KaVo quality product. By following the instructions
below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
Symbols
Refer to the chapter on Safety/Warning symbol
Important information for users and service technicians
Can be steam-sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4 oF)
Thermodisinfectable
CE-Zeichen (Communauté Européenne). Ein Produkt mit diesem Zeichen
entspricht den Anforderungen der anwendbaren EG-Richtlinie.
Action request
Target group
This document is intended for dentists and their assistants. The section on starting up
is also intended for service technicians.
5 / 26

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
2 Safety | 2.1 Description of safety instructions
6 / 26
2 Safety
2.1 Description of safety instructions
Warning symbol
Structure
DANGER
The introduction describes the type and source of the hazard.
This section describes potential consequences of non-compliance.
▶ The optional step includes necessary measures for hazard prevention.
Description of hazard levels
The safety instructions listed here, together with the three levels of danger will help
avert property damage and injury.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to moder‐
ate injuries.
WARNING
WARNING
indicates a hazardous situation that can lead to serious or fatal injury.
DANGER
DANGER
indicates a maximal hazard due to a situation that can directly cause death or fatal
injury.
2.2 Safety instructions
WARNING
Hazard from incorrectly reconditioned products.
An infection hazard exists from contaminated products.
▶ Take suitable personal protective measures.
WARNING
Hazards for the care provider and the patient.
In the case of damage, irregular running noise, excessive vibration, un-typical warm‐
ing or when the cutter or grinder cannot be held.
▶ Do not use further and notify Service.

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
2 Safety | 2.2 Safety instructions
CAUTION
Risk due to incorrectly stored instrument.
Injury and infection caused by chucked cutters or grinders.
Damage to clamping system from dropping the instrument.
▶ After treatment, place the instrument properly in the cradle, without the cutter or
grinder.
CAUTION
Hazard from use as a light probe.
Do not use the device as a light probe since the rotating cutters or grinders can cause
injury.
▶ Use an appropriate light probe for additional illumination of the oral cavity or site
of preparation.
CAUTION
Risks due to lack of control equipment.
Hazards can arise if control equipment is not available for changing the speed and
the direction of rotation.
▶ The dental treatment unit connected must have control equipment for changing
the speed and direction of rotation.
▶ A note is to be included in the documents accompanying the dental treatment
unit, referring to responsibilities arising from safety, reliability and performance.
▶ The medical device may only be combined with a treatment centre released by
KaVo.
CAUTION
Premature wear and malfunctioning from improper storage during long periods of
nonuse.
Reduced product life.
▶ The medical device should be cleaned, serviced and stored in a dry location, ac‐
cording to instructions, before long periods of nonuse.
Note
For safety reasons, we recommend that the tool holder system be checked annually
after the warranty period expires.
The following individuals are authorized to repair and service KaVo products:
▪ Technicians at KaVo branches throughout the world
▪ Technicians specially trained by KaVo
To ensure proper function, the medical device must be set up according to the reproc‐
essing methods described in the KaVo Instructions for Use, and the care products and
care systems described therein must be used. KaVo recommends specifying a service
interval at the dental office for a licensed shop to clean, service and check the func‐
tioning of the medical device. This service interval depends on the frequency of use
and should be adjusted accordingly.
Service may only be carried out by KaVo-trained repair shops using original KaVo re‐
placement parts.
7 / 26

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
3 Product description | 3.1 Purpose – Intended use
8 / 26
3 Product description
MASTERmatic LUX M10 L (Mat. no. 1.009.3570)
3.1 Purpose – Intended use
Indications for use:
This medical device is
▪ intended for dental treatment only. All other types of use or modifications of the
product are not permitted and can be hazardous. The medical device is intended
for the following applications: Removal of carious material, cavity and crown prep‐
arations, removal of fillings, processing of tooth and restoration surfaces.
▪ A medical device according to relevant national statutory regulations.
Proper use:
According to these regulations, this medical device may only be used for the descri‐
bed application by a knowledgeable 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,
▪ adhere to the specified intended use
▪ protect him or herself, the patient and third parties from danger, and
▪ avoid contamination from the product.

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
3 Product description | 3.2 Technical Specifications
3.2 Technical Specifications
Drive speed max. 40,000 rpm-1
Transmission ratio 1:1
Maximum speed: max. 40,000 rpm-1
Identification 1 blue 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 quantity min. 1.5 Nl/min (at 2 bar)
Cooling air flow 5.5 to 9.5 Nl/min
Handpiece cutters or grinders can be used.
Handpiece cutters or grinders can be used.
The handpiece can be mounted on all INTRAmatic (LUX) motors, and motors with a
connection in accordance with ISO 3964 / DIN 13940.
3.3 Transportation and storage conditions
CAUTION
It is hazardous to start up the medical device after it has been stored strongly refriger‐
ated.
This can cause the medical device to malfunction.
▶ Prior to start-up, very cold products must be heated to a temperature of 20oC to
25oC (68oF to 77oF).
Temperature: -20°C to +70°C (-4°F to +158°F)
Relative humidity: 5% RH to 95% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture
9 / 26

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
4 Start up and shut down | 4.1 Check the amount of water
10 / 26
4 Start up and shut down
WARNING
Hazard from non-sterile products.
Infection hazard for care provider and patient.
▶ Before first use and after each use, prepare and sterilise the medical device and
accessories accordingly.
WARNING
Disposal of the product in the appropriate manner.
Prior to disposal, the product and accessories must be appropriately prepared or
sterilised if this is necessary.
4.1 Check the amount of water
CAUTION
Overheating of the tooth due to insufficient amount of cooling water.
Thermal damage to the dental pulp.
▶ Adjust the water amount for the spray cooling to a minimum of 50 ml/min!
CAUTION
Hazard from insufficient spray water.
Insufficient spray water can cause the medical device to overheat and damage the
tooth.
▶ Check the spray water channels and clean the spray nozzles with the nozzle nee‐
dle Mat. no. 0.410.0921 if necessary.

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
5 Operation | 5.1 Attach the medical device
5 Operation
5.1 Attach the medical device
WARNING
Release of the medical device during treatment.
A medical device that is not properly locked in place can release from the motor cou‐
pling and fall off.
▶ Carefully pull on it before each treatment to ensure that the medical device is se‐
curely locked on the motor coupling.
CAUTION
Connect to the drive motor.
Handpiece blocked.
▶ Only start the handpiece when the chuck is closed.
CAUTION
Removing and attaching the handpiece while the drive motor is rotating.
Damage to the catch.
▶ Never attach or remove the handpiece while the device is rotating!
▶ Lightly spray O-rings on motor coupling with KaVo Spray.
▶ Attach medical device to the motor coupling and turn it until you hear the latch
snap into place.
▶ Pull on the medical device to make sure that it is securely affixed to the coupling.
5.2 Remove the medical device
▶ Unlock the medical device from the motor coupling by twisting it slightly and then
pulling it along its axis.
5.3 Insert the handpiece or contra-angle handpiece drill bit.
Note
Only use handpiece or contra-angle handpiece drills that correspond to ISO 1797-1
type 1 and type 2, are made of steel or hard metal and meet the following criteria:
Shaft diameter: 2.334 to 2.350 mm
with a drill bit stop:
- Shaft clamping length: at least 12 mm
- Overall length: max. 22 mm
without a drill bit stop:
- Shaft clamping length: at least 30 mm
- Overall length: max. 44.5 mm
11 / 26

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
5 Operation | 5.4 Remove the handpiece or contra-angle handpiece drill bit
12 / 26
WARNING
Use of unauthorised cutters or grinders.
Injury to the patient or damage to the medical device.
▶ Observe the instructions for use and use the cutter or grinder properly.
▶ Only use cutters or grinders that do not deviate from the specified data.
CAUTION
Injury from using worn drill bits or burs.
Drill bits or burs could fall out during treatment and injure the patient.
▶ Never use drill bits or burs with worn shafts.
CAUTION
Injury hazard from cutters or grinders.
Infections or cuts.
▶ Wear gloves or fingerstalls.
CAUTION
Hazard from defective chucking system.
The cutter or grinder could fall out and cause injury.
▶ Pull on the cutter or grinder to check that the chucking system is okay and the
cutter or grinder is securely held. When checking, inserting and removing, use
gloves or a fingerstall to prevent an injury or infection.
▶ Rotate the clamping ring all the way in the direction of the arrow, and insert the
handpiece cutter or grinder into the chuck.
▶ Turn the clamping ring back into its initial position.
▶ Check that the cutter or grinder is seated by pulling on it.
5.4 Remove the handpiece or contra-angle handpiece drill bit
WARNING
Hazard from rotating cutter or grinder.
Lacerations and damage to the chucking system.
▶ Do not touch the cutter or grinder when it is rotating!
▶ Remove the cutter/grinder from the contra-angle handpiece after treatment to
avoid injury and infection when putting it away.
▶ After the cutter or grinder has stopped rotating, turn the clamping ring in the direc‐
tion of the arrow to the stop.
▶ Turn the clamping ring back into its initial position.
5.5 Conversion for contra-angle handpiece drill bit
Note
The handpiece must be converted to use contra-angle handpiece drill bits.
▶ Open the handpiece chuck.
▶ Insert the enclosed drill stop in the chuck.

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
5 Operation | 5.5 Conversion for contra-angle handpiece drill bit
▶ Press the contra-angle drill bit onto the stop, close the clamping ring, and check
for firm seating.
▶ To remove the drill bit stop, use the accompanying hook.
13 / 26

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
6 Troubleshooting | 6.1 Check for malfunctions
14 / 26
6 Troubleshooting
6.1 Check for malfunctions
CAUTION
Missing or damaged O-rings.
Malfunctions and premature failure.
▶ Make sure that all O-rings are on the coupling and undamaged.
CAUTION
Heating of the product.
Burns or product damage from overheating.
▶ Do not use the product if it is irregularly heated.
▶ The medical device is too hot while idling:
Check the amount of cooling air.
▶ The medical device is too hot while working:
Caring for the medical device.
▶ When the speed drops or is uneven:
Caring for the medical device.
▶ An O-ring is missing on the motor coupling:
Replace O-ring.
6.2 Troubleshooting
6.2.1 Replacing the O-rings
CAUTION
Hazard from improper care of the O-rings.
Malfunctions or complete failure of the medical device.
▶ Do not use Vaseline or other grease or oil.
Note
The O-ring on the coupling may only be lubricated with a cotton ball wet with KAVO
spray.
▶ Press the O-ring between your fingers to form a loop.
▶ Shove the O-ring to the front, and remove it.
▶ Insert new O-rings into the grooves.
6.2.2 Cleaning the spray nozzle
CAUTION
Hazard from insufficient spray water.
Overheating of the medical device and damage to the tooth.
▶ Check the spray water channels and clean the spray nozzles with the nozzle nee‐
dle Mat. no. 0.410.0921 if necessary.
▶ Check the water filter and exchange if necessary.

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
6 Troubleshooting | 6.2 Troubleshooting
▶ Use the nozzle needle (Mat. no. 0.410.0921) to free the water passage in the
spray nozzles.
15 / 26

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparations at the site of use
16 / 26
7 Reprocessing steps in accordance with ISO 17664
7.1 Preparations at the site of use
WARNING
Hazard from nonsterile products.
There is a risk of infection from contaminated medical devices.
▶ Take suitable personal protective measures.
▶ Remove all residual cement, composite or blood immediately.
▶ Reprocess the medical device as soon as possible after treatment.
▶ Remove the cutter or grinder from the medical device.
▶ The medical device must be dry when transported for reprocessing.
▶ Do not place it in solutions or the like.
7.2 Cleaning
CAUTION
Malfunctions from cleaning in the ultrasonic unit.
Defects in the device.
▶ Only clean manually or in a thermodisinfector!
7.2.1 Manual cleaning - external
Accessories required:
▪ Tap water 30 oC ± 5 oC (86 oF ± 10 oF)
▪ Brush, e.g. medium-hard toothbrush
▶ Brush off under flowing tap water.
7.2.2 Automated external cleaning
KaVo recommends washer disinfectors in compliance with EN ISO 15883-1, which
are operated using alkaline cleaning agents.
▶ For program settings as well as cleansers and disinfectants to be used, please re‐
fer to the Instructions for Use of the thermodisinfector.
▶ In order to prevent negative effects on the medical device, make sure that the in‐
terior and the exterior of the medical device are dry after completion of the cycle,
and then grease it immediately with servicing agents from the KaVo care system.
7.2.3 Manual cleaning - internal
Validated interior cleaning (residual protein removal) can only be accomplished with
KaVo CLEANspray and KaVo DRYspray.

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
7 Reprocessing steps in accordance with ISO 17664 | 7.3 Disinfection
▶ Cover the medical device with the KaVo CLEANpac bag, and place it on the cor‐
responding care adapter. Press the spray button three times for 2 seconds each
time. Remove the medical device from the spray attachment and let the cleaner
work for one minute.
▶ Afterwards, rinse for 3-5 seconds with KaVo DRYspray.
See also:
2KaVo CLEANspray / KaVo DRYspray Instructions for Use
Note
KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only avail‐
able in the following countries:
Germany, Austria, Switzerland, Italy, Spain, Portugal, France, Luxembourg, Bel‐
gium, Netherlands, United Kingdom, Denmark, Sweden, Finland and Norway.
In other countries interior cleaning can only be carried out with thermodisinfectors in
accordance with EN ISO 15883-1.
7.2.4 Automated internal cleaning
KaVo recommends washer disinfectors in compliance with EN ISO 15883-1, which
are operated using alkaline cleaning agents.
▶ For programme settings as well as cleansers and disinfectants to be used, please
refer to the Instructions for Use of the washer disinfector.
▶ In order to prevent negative effects on the medical device, make sure that the in‐
terior and the exterior of the medical device are dry after completion of the cycle,
and then grease it immediately with servicing agents from the KaVo care system.
7.3 Disinfection
WARNING
Hazard due to incomplete disinfection.
Principally, KaVo recommends carrying out an final disinfection of the unpackaged
item if complete disinfection cannot be guaranteed without this measure.
CAUTION
Malfunctioning from using a disinfectant bath or chlorine-containing disinfectant.
Defects in the device.
▶ Only disinfect in a washer disinfector or, in unpacked condition, in the autoclave
or manually!
CAUTION
Malfunctioning from using the disinfectant bath or chlorine-containing disinfectants.
Defects in the device.
▶ Do not use an ultrasonic bath.
CAUTION
Never use alkaline or chlorine-containing disinfectants.
The saline solution corrodes the metal parts.
▶ Immediately remove all residue.
17 / 26

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
7 Reprocessing steps in accordance with ISO 17664 | 7.4 Drying
18 / 26
7.3.1 Manual disinfection - external
KaVo recommends the following products based on compatibility of the materials.
The microbiological efficacy must be ensured by the disinfectant manufacturer and
proven by an expert opinion.
▪ Mikrozid AF made by Schülke & Mayr (liquid or cloths)
▪ FD 322 made by Dürr
▪ CaviCide made by Metrex
Consumables required:
▪ Cloths for wiping off the medical device.
▶ Spray the disinfectant on a cloth, then wipe down the medical device and allow
the disinfectant to act according to the instructions of the disinfectant manufactur‐
er.
▶ Follow the instructions for use of the disinfectant.
7.3.2 Manual disinfection - internal
The efficacy of manual internal disinfection must be demonstrated by the manufactur‐
er of the disinfection agent. With KaVo products, use only disinfection agents that
have been released by KaVo, with respect to the compatibility of materials
(e.g. WL-cid / made by ALPRO).
▶ Blow off with compressed air until no water drops are visible.
▶ Immediately after internal disinfection, lubricate the KaVo medical device immedi‐
ately with care agents from the KaVo care system.
7.3.3 Machine disinfection - external and internal
KaVo recommends washer disinfectors in compliance with EN ISO 15883-1, which
are operated using alkaline cleaning agents.
▶ For programme settings as well as cleansers and disinfectants to be used, please
refer to the Instructions for Use of the washer disinfector.
▶ In order to prevent negative effects on the medical device, make sure that the in‐
terior and the exterior of the medical device are dry after completion of the cycle,
and then grease it immediately with servicing agents from the KaVo care system.
7.4 Drying
Manual Drying
▶ Blow off the outside and inside with compressed air until water drops are no lon‐
ger visible.
Automatic Drying
The drying procedure is usually a part of the cleaning program of the thermodisinfec‐
tor.
▶ Follow the instructions for use of the thermodisinfector.

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
7 Reprocessing steps in accordance with ISO 17664 | 7.5 Care products and systems - Servicing
7.5 Care products and systems - Servicing
WARNING
Sharp cutters or grinders in the medical device.
Risk of injury from sharp and/or pointed cutters or grinders.
▶ Remove cutter or grinder.
CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶ Perform proper care regularly!
Note
KaVo only guarantees that its products will function properly when the care prod‐
ucts are used that are listed as accessories since they were tested for proper use
on our products.
7.5.1 Care with KaVo Spray
KaVo recommends servicing the product as part of the reprocessing after each use,
i.e. after each cleaning, disinfection, and before each sterilisation.
▶ Remove the cutter or grinder.
▶ Cover the product with the Cleanpac bag.
▶ Plug the product onto the cannula, and press the spray button for one second.
Servicing of the clamping chuck
KaVo recommends cleaning and servicing the chuck system once a week.
▶ Remove the cutter or grinder, place the spray nipple tip in the opening and spray.
▶ Carry out the servicing according to the instructions in the section, "Care with Ka‐
Vo Spray".
7.5.2 Care with the KaVo SPRAYrotor
▶ Place the product on the appropriate coupling on the KaVo SPRAYrotor and cov‐
er it with the Cleanpac bag.
▶ Servicing the product.
See also:
2Instructions for use KaVo SPRAYrotor
19 / 26

Instructions for use MASTERmatic LUX M10 L - 1.009.3570
7 Reprocessing steps in accordance with ISO 17664 | 7.5 Care products and systems - Servicing
20 / 26
7.5.3 Servicing with KaVo QUATTROcare 2104 / 2104A
Note
QUATTROcare 2104 / 2104 A is no longer included in the current delivery pro‐
gramme.
Follow-up products:
▶ QUATTROcare PLUS 2124 A
▶ QUATTROcare CLEAN 2140 A
Servicing and cleaning device with expansion pressure for the interior cleaning of inor‐
ganic residues and optimum care.
(no validated cleaning of the interior in accordance with German RKI requirements)
KaVo recommends servicing the product as part of the reprocessing after each use,
i.e. after each cleaning, disinfection, and before each sterilisation.
▶ Remove the cutter or grinder.
▶ Servicing the product.
See also:
2Instructions for use KaVo QUATTROcare 2104 / 2104A
Servicing of the clamping chuck
KaVo recommends cleaning and servicing the chuck system once a week.
See also:
2Instructions for use KaVo QUATTROcare 2104 / 2104A
▶ Remove the cutter or grinder, place the spray nipple tip in the opening and spray.
▶ Subsequently treat with the specified care products and systems.
See also:
2Servicing with KaVo QUATTROcare 2104 / 2104A
7.5.4 Servicing with KaVo QUATTROcare PLUS 2124 A
Servicing and cleaning device with expansion pressure for the interior cleaning of inor‐
ganic residues and optimum care.
(no validated cleaning of the interior in accordance with German RKI requirements)
▶ Remove the cutter or grinder.
▶ Servicing the product in the QUATTROcare PLUS.
See also:
2Instructions for Use KaVo QUATTROcare PLUS 2124 A