KaVo SURGmatic S11 L User manual

Instructions for use
SURGmatic S11 L – 1.009.1010
SURGmatic S11 C – 1.009.1005

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

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
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 ........................................................................................................ 8
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...................................................................................................... 12
4.1 Checking the amount of water ........................................................................................ 12
5 Operation........................................................................................................................... 14
5.1 Attaching the medical device .......................................................................................... 14
5.2 Removing the medical device.......................................................................................... 14
5.3 Inserting the dental bur.................................................................................................. 15
5.4 Removing the dental bur ................................................................................................ 16
5.5 Modification for contra-angle burs ................................................................................... 16
6 Checking for malfunctions and troubleshooting ............................................................... 17
6.1 Check for malfunctions................................................................................................... 17
6.2 Troubleshooting............................................................................................................. 17
6.2.1 Cleaning the spray tube .................................................................................... 17
7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 .............................. 19
7.1 Preparations at the site of use......................................................................................... 19
7.2 Manual Reprocessing ..................................................................................................... 19
7.3 Automated reprocessing................................................................................................. 20
7.3.1 Preliminary cleaning of the spray tube ................................................................ 20
7.3.2 Automated internal and external cleaning and internal and external disinfection...... 20
7.3.3 Automated drying............................................................................................. 21
7.4 Care products and systems - Servicing ............................................................................ 21
7.4.1 Servicing with KaVo Spray................................................................................. 21
7.4.2 Servicing with KaVo QUATTROcare PLUS ............................................................ 22
7.5 Packaging ..................................................................................................................... 22
7.6 Sterilisation................................................................................................................... 23
7.7 Storage ........................................................................................................................ 23
8 Optional aids and consumables......................................................................................... 24
9 Terms and conditions of warranty .................................................................................... 25

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
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
SMARTmatic is a registered trademark of KaVo Dental GmbH.
All other trademarks are property of their respective owners.
KaVo Original Factory Repair
In the event of a repair, please ship your product to the KaVo Original Factory
Repair using www.kavobox.com.
KaVo Technical Service
If you have any technical questions or complaints, please contact the KaVo
Technical Service:
[phone]
[e-mail]
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
CE- mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directives.
Medical device, labelling of medical devices
Sterilisable by steam
Thermodisinfectable
Information on the packaging
Material number

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1 User instructions
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Serial number
UDI symbol
Manufacturer
Note: Please note accompanying documents
Follow the electronic instructions for use
HIBC Code
CE mark for medical devices
EAC conformity mark (Eurasian Conformity)
Medical device, labelling of medical devices
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.
Individual warning notes must be observed in the corresponding chapters.
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.
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8
4Never use the instrument to keep the cheek, tongue or lip at a distance.
4Do not allow the medical device to rotate at eye level.
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.

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2 Safety | 2.3 Technical condition
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2.3 Technical condition
A damaged product or damaged or NOT KaVo original components could injure
patients, users or third parties.
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 (e.g., from dropping)
▪ 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.
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.
4Only use accessories that are equipped with standardised interfaces.
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.
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 Safety | 2.6 Service and repair
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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.
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.

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
3 Description of the product | 3.1 Intended use
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3 Description of the product
SURGmatic S11 L (Mat. no. 1.009.1010)
SURGmatic S11 C (Mat. no. 1.009.1005)
3.1 Intended use
Indications for use:
This medical device is:
▪ Intended for dental treatment only. All other types of use of or modifications
to the product are not permitted and can be hazardous.
▪ The medical device is intended for the following applications: surgical applic-
ation areas, e.g.:
– Setzen eines Implantats
– Knochenaugmentation
– Sinuslift
– Dental extractions
– Implantology
– Oral-Maxillo-Facial Surgery
▪ A medical device according to relevant national statutory regulations.
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:
▪ exclusive use of equipment that is operating correctly.
▪ compliance with the specified intended use.
▪ Protect themselves, patients and third parties from danger.
▪ Contamination by the product must be avoided.

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3 Description of the product | 3.2 Technical Specifications
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3.2 Technical Specifications
Drive speed max. 40,000 rpm
Speed transmission 1 : 1
Identification 1 blue ring
Can be attached to All INTRA (LUX) surgical motors with a
connector in accordance with DIN EN
ISO 3964
Insert Cutter or diamond grinder according
to DIN EN ISO 1797 type 2, for use of
a bur stop cutter and diamond grinder
according to DIN EN ISO 1797 type 1
Also refer to:
5.3 Inserting the dental bur,Page15
3.3 Transportation and storage conditions
CAUTION
Startup after refrigerated storage.
Malfunction.
4Prior to startup, strongly refrigerated products must be allowed to warm up
to a temperature of 20 °C to 25 °C (68 °F to 77 °F).
Temperature: -29°C to +50°C (-20°F to +122°F)
Relative humidity: 5% RH to 85% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture (Keep dry)

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
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.
Patients, users or third parties could be infected by contaminated medical
devices.
4Prior to initial startup and after each use, reprocess the product and ac-
cessories.
WARNING
Dispose of the product in appropriate manner.
Patients, users or third parties could be infected by contaminated medical
devices.
4Reprocess the product and accessories before disposal.
Also refer to:
7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2,Page19
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.
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 spray water ducts and, if necessary, clean spray tubes with the
nozzle needle (Mat. no. 0.410.0931).
4Ensure that the coolant supply is free of air.

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
4 Startup and shut down | 4.1 Checking the amount of water
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4Cool the dental bur via an external supply.
4During surgical interventions, comply with the necessary precautions re-
garding cooling.
4Use physiological, sterile cooling fluid.
4Do not use any other coolants.
4Carefully plug the coolant hose in central position onto the media tube pro-
ceeding in axial direction.

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
5 Operation | 5.1 Attaching the medical device
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5 Operation
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.
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
CAUTION
Removing the medical device.
Injury hazard from slipping while pulling off the medical device.
4Mind the spray tube when you pull off 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.

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5 Operation | 5.3 Inserting the dental bur
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5.3 Inserting the dental bur
NOTE
Only use carbide burs or diamond burs that conform to DIN EN ISO 1797 type
1 and type 2, are made of steel or hard metal, and meet the following cri-
teria:
- Shaft diameter: 2.334 to 2.350 mm
with a drill bit stop:
- Shaft clamping length: at least 12mm
- Shaft clamping length: max. 22mm
without a drill bit stop:
- Shaft clamping length: at least 30mm
- Shaft clamping length: max. 44.5mm
WARNING
Use of unauthorised 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
Contaminated, sharp-edged dental bur.
Infections or cuts.
4Use gloves or a finger guard when you test, insert and remove the dental
bur.
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.

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5 Operation | 5.4 Removing the dental bur
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CAUTION
Incorrectly clamped dental bur.
Material damage to the chuck system, dental bur is difficult or impossible to re-
move from the chuck system.
4Never use dental burs with shortened shafts.
4Never use dental burs that show recesses, tapering, diamond coding or cut-
ting geometries in the section corresponding to the clamped length.
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.
4Rotate the clamping ring in the direction of the arrow to the bur stop and in-
sert the dental bur into the chuck.
4Turn the clamping ring back into its initial position.
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.
4Do not touch the dental bur while it is rotating.
4Remove the dental bur from the handpiece after treatment to avoid injury
and infection during storage.
4After the dental bur has come to a standstill, turn the clamping ring in the
direction of the arrow as far as the bur stop and remove the dental bur.
4Turn the clamping ring back into its initial position.
5.5 Modification for contra-angle burs
NOTE
When using contra-angle handpiece burs, the handpiece must be converted.
4Open the handpiece chuck.
4Insert the enclosed bur stop in the chuck.
4Press contra-angle bur to bur stop, close clamping ring and check that it is
firmly seated.
4Use the enclosed hook to remove the bur stop.

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6 Checking for malfunctions and troubleshooting | 6.1 Check for malfunctions
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6 Checking for malfunctions and troubleshooting
6.1 Check 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.
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 Cleaning the spray tube
WARNING
Hazard from contaminated products.
Patients, users or third parties could be infected by contaminated medical
devices.
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 spray water ducts and, if necessary, clean spray tubes with the
nozzle needle (Mat. no. 0.410.0931).

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6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting
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4Use the nozzle needle (Mat. no. 0.410.0931) to free the water passage at
the spray tubes.

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.1 Preparations at the site of use
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7 Reprocessing steps in accordance with ISO 17664-1 /
ISO 17664-2
7.1 Preparations at the site of use
WARNING
Hazard from contaminated products.
Patients, users or third parties could be infected by contaminated medical
devices.
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.
4To minimise the risk of infection during reprocessing, always wear protect-
ive gloves.
4Reprocess the medical device right after treatment.
4Remove all residual cement, composite or blood immediately.
4Wipe-disinfect the medical device before transport.
4Remove the dental bur from the medical device.
4Do not place in solutions or similar substances.
CAUTION
Never reprocess the medical device with chloride-containing products.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
KaVo recommends the following products based on the compatibility of the ma-
terials. The microbiological efficacy must be ensured by the disinfectant manu-
facturer and proven by an expert opinion.
Approved disinfectants:
▪ CaviWipes and CaviCide made by Metrex
▪ Mikrozid AF made by Schülke & Mayr (Liquid or wipes)
▪ FD 322 made by Dürr
Consumables required:
▪ Cloths for wiping the medical device.
4Spray the disinfectant on a cloth, then wipe down the medical device and al-
low the disinfectant to act according to the instructions of the disinfectant
manufacturer.
4Follow the instructions for use of the disinfectant.
7.2 Manual Reprocessing
This product is not designed for manual internal and external cleaning and
manual internal and external disinfection.
For effective reprocessing, automated internal and external cleaning as well as
automated internal and external disinfection with a cleaning and disinfection
unit in accordance with EN ISO 15883-1 is required.

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.3 Automated reprocessing
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7.3 Automated 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 the medical device with chloride-containing products.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
CAUTION
Never reprocess this medical device in an ultrasonic cleaner.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
7.3.1 Preliminary cleaning of the spray tube
The preliminary cleaning is a central constituent and must be carried out prior
to the automatic reprocessing.
Accessories required:
▪ Demineralised water 30 °C ± 2 °C (86 °F ± 3.6 °F)
▪ Nozzle needle
▪ Brush, e.g. medium-hard toothbrush
▪ Disposable syringe
4Check the patency of the spray tube and clean the tube using the nozzle
needle (Mat. no. 0.410.0931).
4Rinse the spray tube with at least 20 ml demineralised water using a dispos-
able syringe.
4If the spray tube is not patent after the manual rinsing procedure, the med-
ical device must be replaced.
4Brush the spray tube and hose under running tap water water for at least
20 seconds using a medium-hard toothbrush.
For validated internal cleaning of the media ducts in the cleaning and disinfect-
ing device, preliminary cleaning is required.
7.3.2 Automated internal and external cleaning and
internal and external disinfection
NOTE
Prior to cleaning or disinfection in a washer disinfector, attach the head to an
appropriate shank.
KaVo recommends washer disinfectors in accordance with EN ISO 15883-1,
which are operated using alkaline cleaning agents.