KaVo SMARTmatic PROPHY S19 User manual

Instructions for use
SMARTmatic PROPHY S19 - 1.011.6740
SMARTmatic PROPHY S19 K - 1.011.6741

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

Table of contents
1 User instructions............................................................................................................................................. 4
2 Safety ............................................................................................................................................................. 6
2.1 Infection hazard ..................................................................................................................................... 6
2.2 Technical condition ................................................................................................................................ 6
2.3 Accessories and combination with other equipment.............................................................................. 7
2.4 Qualification of personnel ...................................................................................................................... 7
2.5 Service and repair.................................................................................................................................. 7
3 Description of the product............................................................................................................................... 9
3.1 Intended use .......................................................................................................................................... 9
3.2 Technical Specifications ........................................................................................................................ 10
3.3 Transportation and storage conditions .................................................................................................. 11
4 Startup and shut down.................................................................................................................................... 12
5 Operation........................................................................................................................................................ 13
5.1 Attaching the medical device ................................................................................................................. 13
5.2 Removing the medical device................................................................................................................ 13
5.3 Attach the prophylaxis head .................................................................................................................. 14
5.4 Removing the prophylaxis head ............................................................................................................ 15
6 Checking for malfunctions and troubleshooting.............................................................................................. 16
6.1 Checking for malfunctions ..................................................................................................................... 16
6.2 Troubleshooting ..................................................................................................................................... 16
6.2.1 Replacing the O-rings ............................................................................................................... 16
7 Reprocessing steps in accordance with ISO 17664 ....................................................................................... 17
7.1 Preparations at the site of use ............................................................................................................... 17
7.2 Cleaning................................................................................................................................................. 17
7.2.1 Manual external cleaning .......................................................................................................... 17
7.2.2 Automated external cleaning .................................................................................................... 17
7.2.3 Manual internal cleaning ........................................................................................................... 17
7.2.4 Automated internal cleaning ..................................................................................................... 18
7.3 Disinfection ............................................................................................................................................ 18
7.3.1 Manual external disinfection ..................................................................................................... 18
7.3.2 Manual internal disinfection ...................................................................................................... 19
7.3.3 Automated external and internal disinfection ............................................................................ 19
7.4 Drying .................................................................................................................................................... 19
7.5 Care products and systems - Servicing ................................................................................................. 19
7.5.1 Servicing with KaVo Spray........................................................................................................ 20
7.5.2 Servicing with KaVo SPRAYrotor ............................................................................................. 21
7.5.3 Servicing with KaVo QUATTROcare ........................................................................................ 21
7.5.4 Servicing with KaVo QUATTROcare PLUS ............................................................................. 21
7.6 Packaging .............................................................................................................................................. 22
7.7 Sterilisation ............................................................................................................................................ 23
7.8 Storage .................................................................................................................................................. 23
8 Tools and consumables.................................................................................................................................. 24
9 Terms and conditions of warranty .................................................................................................................. 25
Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
Table of contents
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Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
1 User instructions
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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
KaVo Repair Service
For repairs, please contact your local dealer or the KaVo Repair Service directly:
[phone]
[email protected]
KaVo Technical Service
If you have any questions or complaints, please contact the KaVo Technical service:
[phone]
[email protected]
Target group
This document is intended for dentists and their assistants. The startup section is also
intended for service technicians.
General marks and symbols
Refer to the chapter on Safety/Warning symbol
Important information for users and service technicians
Action request
CE mark (European Community). A product bearing this mark meets the re-
quirements of the applicable EC directive.
Can be steam-sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4 oF)
Thermodisinfectable
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:
DANGER
In cases which – if not prevented – directly lead to death or severe injury.
WARNING
In cases which – if not prevented – could lead to death or severe injury.

Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
1 User instructions
CAUTION
In cases which – if not prevented – could lead to minor or moderate injury.
NOTICE
In cases which – if not prevented – could lead to material damage.
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Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
2 Safety | 2.1 Infection hazard
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2 Safety
The instructions for use are a component of the product and must be read carefully
prior to use and be accessible at all times.
The device may only be used in accordance with the instructions for 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.
▶ Take suitable personal protective measures.
▶ Follow the instructions for using the components.
▶ Before the initial startup and after each use, prepare and sterilise the medical
device and accessories accordingly.
▶ Carry out the cleaning and sterilisation as described in the instructions for use.
The procedure has been validated by the manufacturer.
▶ It is essential to ensure the effectiveness of the cleaning and sterilisation in the
case of deviation in procedure.
▶ Prior to disposal, the product and accessories must be appropriately prepared or
sterilised.
▶ In the case of injury to soft tissue, do not continue treatment in the oral cavity with
instruments driven by compressed air.
▶ Use gloves or finger guard whenever you test, insert, and remove the tool.
2.2 Technical condition
A damaged device or components could injure patients, users and third parties.
▶ Only operate devices or components if they are undamaged on the outside.
▶ Check that the device is working properly and is in satisfactory condition before
each use.
▶ Have parts with sites of breakage or surface changes checked by the Service.
▶ If the following defects occur, stop working and have the service personnel carry
out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
▪ Tool is not seated firmly in the handpiece
Observe the following instructions in order to guarantee optimum functioning and pre-
vent material damage:
▶ Service the medical device with care products and systems regularly as described
in the instructions for use.
▶ The device should be cleaned, serviced and stored in a dry location, according to
instructions, if it will not be used for a longer period.
High torque of micromotors can lead to severe burn injuries.
▶ Service micromotors regularly.
▶ Do no use any damaged motors.

Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
2 Safety | 2.3 Accessories and combination with other equipment
▶ Do not use motors for unauthorised purposes.
2.3 Accessories and combination with other equipment
Use of un-authorised accessories or un-authorised modifications of the device could
lead to injury.
▶ Only use accessories that have been approved for combination with the product
by the manufacturer.
▶ Only use accessories that are equipped with standardised interfaces.
▶ Do not make any modifications to the device unless these have been approved by
the manufacturer of the product.
The lack of control equipment for changing the speed range and the direction of rota-
tion can lead to injury.
▶ Control facility for changing the speed and the direction of rotation must be
present.
▶ The medical device may only be combined with a treatment centre released by
KaVo.
▶ Comply with the Instructions for Use of the treatment centre.
The lack of control equipment for changing the speed range and the direction of rota-
tion can lead to injury.
▶ Control facility for changing the speed and the direction of rotation must be
present.
▶ The medical device may only be combined with a treatment centre released by
KaVo.
▶ Comply with the Instructions for Use of the treatment centre.
2.4 Qualification of personnel
Application of the product by users without the appropriate medical training could in-
jure the patients, the users or third parties.
▶ Make sure that the user has read and understood the instructions for use.
▶ Only employ the device if the user has the appropriate medical training.
▶ Observe national and regional regulations.
The improper use of the device could lead to burns or injuries.
▶ After treatment, place the medical device properly in the cradle without the tool.
2.5 Service and repair
Repairs, servicing and safety checks may only be performed by trained service per-
sonnel. 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 train-
ing
Observe all the following items during servicing work:
▶ Have the service and testing tasks carried out in accordance with the Medical
Product Operator Ordinance.
▶ Following expiry of the warranty, have the tool holding system checked once a
year.
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Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
2 Safety | 2.5 Service and repair
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▶ KaVo recommends specifying in-house service intervals where the medical device
is brought to a professional shop for cleaning, servicing and a function check.
Defined the service interval depending on the frequency of use.

Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
3 Description of the product | 3.1 Intended use
3 Description of the product
SMARTmatic PROPHY S19 (Mat. No. 1.011.6740)
SMARTmatic PROPHY S19 K (Mat. No. 1.011.6741)
3.1 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 can be used
in combination with a polishing tool to support the periodontal treatment by polish-
ing with a rotating tool.
▪ A medical device according to relevant national statutory regulations.
Proper use:
According to these provisions, this medical device 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:
▪ to only use equipment that is operating correctly,
▪ adhere to the specified intended use
▪ to protect him or herself, the patient and third parties from hazards, and
▪ to prevent contamination from the product
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Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
3 Description of the product | 3.2 Technical Specifications
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3.2 Technical Specifications
Drive speed max. 20,000 rpm
Speed transmission 8:1
Cooling air flow 5.5 to 9.5 Nl/min
Prophylaxis heads with a Doriot connector can be inserted. Shaft and/or drive shaft in
accordance with DIN EN ISO 14457 for:
▪ metallic and ceramic materials: Ø2.35 0/-0.016mm.
▪ Plastics: Ø2.35 0/-0.05mm.
Handpiece S19 can be mounted on all INTRAmatic (LUX) motors, and motors with a
connection in accordance with ISO 3964 / DIN 13940.
Handpiece S19 K can be attached to the INTRA Motor 181K.

Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
3 Description of the product | 3.3 Transportation and storage conditions
3.3 Transportation and storage conditions
NOTICE
Startup after refrigerated storage.
Malfunction.
▶ Prior to startup, very cold products must be heated up to a temperature of 20 °C
to 25 °C (68 °F to 77 °F).
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
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4 Startup and shut down
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4 Startup and shut down
WARNING
Hazard from non-sterile products.
Infection hazard for care provider and patient.
▶ Before first use and after each use, sterilise the medical device.
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
▶ Before disposal, reprocess and sterilise the product and accessories appropri-
ately.
NOTICE
Damage from soiled and moist cooling air.
Contaminated and moist cooling air can cause malfunctions.
▶ Make sure that the supply of cooling air is dry, clean, and uncontaminated accord-
ing to EN ISO 7494-2.
NOTICE
Damage to the handpiece caused by spray air and spray water.
Property damage
▶ Un-select spray air and spray water on the supply unit before startup!

Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
5 Operation | 5.1 Attaching the medical device
5 Operation
5.1 Attaching the medical device
CAUTION
Detachment of the medical device during treatment.
Injury or property damage
A medical device that is not properly locked in place can become disconnected from
the motor coupling and fall off.
▶ Carefully pull on the medical device before each treatment to ensure that it is se-
curely locked onto the motor coupling.
NOTICE
Removing and attaching the handpiece while the drive motor is rotating.
Damage to the driver.
▶ Never attach or remove the handpiece while the drive motor is rotating.
▶ Lightly spray O-rings on motor coupling with KaVo Spray.
▶ Attach the handpiece to the motor coupling until it locks into place.
▶ Before each treatment, pull on the medical device to make sure that the hand-
piece is securely seated on the motor coupling.
5.2 Removing the medical device
▶ Unlock the handpiece from the motor coupling in axial direction and remove it, or
pull it off by twisting it slightly.
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Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
5 Operation | 5.3 Attach the prophylaxis head
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5.3 Attach the prophylaxis head
Note
All prophylaxis heads with a Doriot connection can be attached.
The clamping system is designed for drive shafts working in accordance with DIN
EN ISO 14457 for metallic and ceramic materials: Ø2.35 0/-0.016mm and plastic
materials: Ø2.35 0/-0.05mm.
WARNING
Use of unauthorised prophylaxis heads.
Injury to the patient or damage to the medical device.
▶ Comply with the instructions for use and the intended use of the tools.
▶ Only use prophylaxis heads that do not deviate from the specified data.
WARNING
Damaged prophylaxis head.
Injuries.
▶ Check the prophylaxis head for damage before each use.
▶ See the manufacturer's instructions for use.
NOTICE
Rotating prophylaxis head.
Damage to the chucking system.
▶ Never attach or remove the prophylaxis head while the device is rotating!
▶ Attach the prophylaxis head on the handpiece proceeding in axial direction to the
limit stop.
▶ Before the start of treatment, check if the seat is secure by pulling on the head.

Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
5 Operation | 5.4 Removing the prophylaxis head
5.4 Removing the prophylaxis head
▶ Remove the prophylaxis head axially from the handpiece.
CAUTION
Hazard due to incorrectly stored instrument.
Injury and infection from clamped prophylaxis head.
▶ After each treatment, place the instrument properly in the cradle without the pro-
phylaxis head.
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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
Missing or damaged O-rings.
Malfunction and premature failure.
▶ Make sure that all O-rings are on the coupling and are 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 working:
Service the medical device.
▶ When the speed drops or is uneven:
Service the medical device.
▶ An O-ring is missing on the motor coupling:
Replace O-ring.
See also:
2Instructions for use of motor
6.2 Troubleshooting
6.2.1 Replacing the O-rings
CAUTION
Hazard from improper care of the O-rings.
Functional problem or complete failure of the medical device.
▶ Do not use Vaseline or other grease or oil.
Note
The O-rings on the coupling may only be lubricated with a cotton ball wetted with
KaVo Spray.
▶ Press the O-ring between your fingers to form a loop.
▶ Push the O-ring to the front, and remove it.
▶ Insert new O-rings into the grooves.

Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparations at the site of use
7 Reprocessing steps in accordance with ISO 17664
7.1 Preparations at the site of use
WARNING
Hazard from non-sterile 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 prophylaxis head from the medical device
▶ The medical device must be dry when transported to reprocessing.
▶ Do not place in solutions or similar substance.
7.2 Cleaning
NOTICE
Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.
▶ Clean manually or in a washer disinfector only.
7.2.1 Manual external cleaning
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 that are
operated with alkaline cleaning agents.
The validations were conducted with the VARIO-TD program, the cleaning agent
neodisher® MediClean and the neutralisation agent neodisher® Z.
▶ The program settings and cleansers and disinfectants that must be used can be
found in the instructions for use of the thermodisinfector.
▶ In order to prevent negative effects on the KaVo medical device, make sure that
the interior 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 internal cleaning
Validated internal cleaning (removal of residual protein) can be accomplished with
KaVo CLEANspray and KaVo DRYspray.
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Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
7 Reprocessing steps in accordance with ISO 17664 | 7.3 Disinfection
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▶ 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 cleanser
act 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 that are
operated with alkaline cleaning agents.
The validations were conducted with the VARIO-TD program, the cleaning agent
neodisher® MediClean and the neutralisation agent neodisher® Z.
▶ For program settings as well as cleansers and disinfectants to be used, please
refer to the Instructions for Use of the thermodisinfector.
▶ In order to prevent negative effects on the KaVo medical device, make sure that
the interior 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
Incomplete disinfection.
Infection hazard.
▶ Principally, KaVo recommends carrying out an final disinfection of the unpack-
aged item to guarantee the complete disinfection.
NOTICE
Using the disinfectant bath or chlorine-containing disinfectants.
Malfunction and material damage.
▶ Do not disinfect the device in the disinfection bath or with chlorine-containing dis-
infectants.
7.3.1 Manual external disinfection
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

Instructions for use SMARTmatic PROPHY S19 - 1.011.6740 SMARTmatic PROPHY S19 K - 1.011.6741
7 Reprocessing steps in accordance with ISO 17664 | 7.4 Drying
Consumables required:
▪ Cloths for wiping 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 manufacturer.
Note
Follow the instructions for use of the disinfectant.
7.3.2 Manual internal disinfection
The efficacy of manual internal disinfection must be demonstrated by the manufac-
turer 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 with care
agents from the KaVo care system.
7.3.3 Automated external and internal disinfection
KaVo recommends washer disinfectors in compliance with EN ISO 15883-1 that are
operated with alkaline cleaning agents.
The validations were conducted with the VARIO-TD program, the cleaning agent
neodisher® MediClean and the neutralisation agent neodisher® Z.
▶ 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 KaVo medical device, make sure that
the interior 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
longer visible.
Automatic Drying
The drying procedure is usually part of the cleaning programme of the washer disin-
fector.
▶ Follow the instructions for use of the thermodisinfector.
7.5 Care products and systems - Servicing
NOTICE
Improper service and care.
Premature wear and reduced product service life.
▶ Service regularly with suitable agents.
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7 Reprocessing steps in accordance with ISO 17664 | 7.5 Care products and systems - Servicing
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Note
KaVo guarantees the proper function of KaVo products only if the care products lis-
ted as accessories are used, since these were tested for proper use on our
products.
7.5.1 Servicing 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 tool.
▶ Cover the product with the Cleanpac bag.
▶ Plug the product onto the cannula, and press the spray button for one second.
Servicing the chucking system
KaVo recommends cleaning and servicing the chuck system once a week.
▶ Remove the tool, place the spray nipple tip in the opening and spray.
▶ Carry out the servicing according to the instructions in the section, "Servicing with
KaVo Spray".