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 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 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 Product description ........................................................................................................... 10
3.1 Intended use................................................................................................................. 10
3.2 Technical Specifications.................................................................................................. 12
3.3 Transportation and storage conditions ............................................................................. 12
4 Startup and shut-down...................................................................................................... 13
4.1 Checking the water quantity ........................................................................................... 13
5 Operation........................................................................................................................... 15
5.1 Attaching the medical device .......................................................................................... 15
5.2 Removing the medical device.......................................................................................... 15
5.3 Inserting the bur ........................................................................................................... 16
5.4 Remove the bur ............................................................................................................ 17
5.5 Modification for contra-angle burs ................................................................................... 17
6 Checking for malfunctions and troubleshooting ............................................................... 18
6.1 Check for malfunctions................................................................................................... 18
6.2 Troubleshooting............................................................................................................. 18
6.2.1 Cleaning the spray tube .................................................................................... 18
7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 .................................. 20
7.1 Preparations at the site of use......................................................................................... 20
7.2 Manual processing ......................................................................................................... 20
7.3 Automated processing.................................................................................................... 21
7.3.1 Preliminary cleaning of the spray tube ................................................................ 21
7.3.2 Automated internal and external cleaning and internal and external disinfection...... 21
7.4 Care products and systems - Servicing ............................................................................ 22
7.4.1 Servicing with KaVo Spray................................................................................. 22
7.4.2 Servicing with KaVo QUATTROcare PLUS ............................................................ 23
7.5 Packaging ..................................................................................................................... 23
7.6 Sterilization................................................................................................................... 24
7.7 Storage ........................................................................................................................ 24
8 Optional aids and consumables......................................................................................... 25
9 Terms and conditions of warranty .................................................................................... 26

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 in-
structions below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
SURGmatic is a registered trademark of 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 office 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 directive.
Medical device, labeling of medical devices
Sterilizable by steam
Thermodisinfectable
Information on the packaging
Catalog number

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
1 User instructions
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Serial number
UDI symbol
Manufacturer
Attention: Please consult the accompanying documents
Follow the electronic instructions for use
HIBC Code
CE mark for medical devices
EAC conformity mark (Eurasian Conformity)
Medical device, labeling of medical devices
Transportation and storage conditions
(temperature range)
Transportation and storage conditions
(air pressure)
Transportation and storage conditions
(humidity)
Protect from moisture
Protect from impact
Original language German
Hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and property 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.
NOTICE
In cases which – if not prevented – can lead to property 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 a component of the product and must be read care-
fully prior to use and 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 can be infected by contaminated medical de-
vices.
4Take suitable personal protective measures.
4Follow the instructions for use of the components.
4Before initial startup and after each use, process the product and acces-
sories appropriately.
4Carry out the processing as described in the instructions for use. The proce-
dure has been validated by the manufacturer.
4If you deviate from this validated procedure, make sure that the processing
procedure is effective.
4Process the product and accessories appropriately before disposal.
4Use gloves or a finger guard when you test, insert and remove the 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
bur.

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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.
4Use the device and components only if there is no 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 Ser-
vice.
4If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage (e.g. caused by being dropped)
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
▪ 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 with care products and systems regularly as de-
scribed in the instructions for use.
4The product should be processed 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 un-authorized accessories on the device or un-authorized modifications
to the device can 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 facility for changing the speed and the direction of rotation must be
present.
4Comply with the Instructions for Use of the treatment center / control unit.
2.5 Qualification of personnel
Application of the product by users lacking appropriate medical training can in-
jure the patient, the user or third parties.
4Make sure that the user has read and comprehends the instructions for use.
4Make sure that the user has read and comprehends the national and re-
gional regulations.
4Only employ the device if the user has 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 authorized to do this:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorized dealers after the appropriate product
training
Comply with the following items during all servicing work:
4Have the service and testing tasks carried out in accordance with the Medi-
cal Device Operation Ordinance.
4Following expiration of the warranty, have the tool holding system checked
once a year.
4Have the medical device evaluated by a professional shop with regard to its
cleaning, servicing and functional needs according to an in-house service in-
terval. 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 peo-
ple. 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 into the market of a modified product, where there is reason-
able suspicion that the safety and health of patients or users may be jeopar-
dized, is prohibited by the German medical device law §4, section 1 no. 1 and
requires a separate conformity check.

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
3 Product description | 3.1 Intended use
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3 Product description
SURGmatic S11 L (Mat. No. 1.009.1010)
SURGmatic S11 C (Mat. No. 1.009.1005)
The electric driven SURGmatic handpieces are dental handpieces in accordance
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 electric driven handpieces that are reusable and ergonomically
shaped, and are provided with a fiber optic light system. The dental handpieces
can be sterilized in a steam sterilizer (autoclave). SURGmatic handpieces
equipped with a handpiece connector in accordance with ISO 3964 are con-
nected to a treatment unit by means of a hose and the electrical motor and re-
ceive 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 SURGmatic handpieces. Based on the INTRAmatic connection that
meets the ISO 3964 standard, the SURGmatic handpieces fit with any electrical
dental motor which is produced in accordance to this standard. The SURGmatic
handpieces interact with the patient through a rotating bur with the patient's
teeth according to the intended use.
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 is designed for the following applications: surgery, e.g.:
– Setting a dental implant
– Bone augmentation
– Sinus lift
– Tooth extraction
– Implantology
– Oral, jaw and facial surgery
▪ A medical device in accordance with the relevant national statutory regula-
tions.
CAUTION
US Federal law restricts this device to sale by or on the order of a
healthcare professional / dentist.
For dental use only.

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3 Product description | 3.1 Intended use
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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
In accordance with these regulations, the user is required to:
▪ Only use equipment that is operating properly.
▪ Comply with the specified intended use.
▪ Protect himself or herself, the patient and third parties from hazards.
▪ Prevent contamination by the product.

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3 Product description | 3.2 Technical Specifications
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3.2 Technical Specifications
Drive speed max. 40,000 rpm
Speed transmission 1 : 1
Labeling 1 blue ring
Can be attached to All INTRA (LUX) surgical motors with a
connector in accordance with ISO
3964
Insert A ISO 1797 type 2 cutter or diamond;
if you use bur stop it is a ISO 1797
type 1 cutter or diamond
Also refer to:
5.3 Inserting the bur,Page16
3.3 Transportation and storage conditions
4Do not store in a refrigerated environment.
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

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
4 Startup and shut-down | 4.1 Checking the water quantity
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4 Startup and shut-down
WARNING
Hazard from contaminated products.
Patients, users or third parties can be infected by contaminated medical de-
vices.
4Prior to initial startup and after each use, process the product and acces-
sories.
WARNING
Dispose of the product in the appropriate manner.
Patients, users or third parties can be infected by contaminated medical de-
vices.
4Process the product and accessories before disposal.
Also refer to:
7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2,Page20
Current packaging law
Dispose of the packaging properly in accordance with the current packaging law
using disposal companies/recycling firms. Comply with the comprehensive re-
turn system. KaVo has had its packaging licensed for this purpose. Please com-
ply with the regional public waste-disposal system.
4.1 Checking the water quantity
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 amount for the spray cooling to a minimum of 50 ml/min
(3.1 inch3).
4Check spray water channels and, if applicable, 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 water quantity
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4Cool the 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
Detachment of the medical device during treatment.
A medical device that is not properly locked can detach from the coupling dur-
ing treatment.
4Before each use, pull on the medical device to make sure that it is securely
locked onto the coupling.
NOTICE
Connection to the drive motor.
Straight or contra-angle handpiece jams.
4Operate the straight or contra-angle handpiece only with the chuck being
closed.
NOTICE
Removing and attaching the straight or contra-angle handpiece while
the drive motor is rotating.
Damage to the driver.
4Never attach or remove the straight or contra-angle handpiece while the
drive motor is rotating.
NOTICE
Pressing the foot switch while attaching or detaching the medical de-
vice.
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.
4Attach the medical device to the motor coupling and turn it until the latch
audibly snaps into place.
4Pull on the medical device to make sure that it is securely affixed to the cou-
pling.
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 bur
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5.3 Inserting the bur
NOTE
Only use carbide burs or diamond burs that conform to ISO 1797 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 bur stop:
- Shaft clamping length: at least 12mm
- Shaft clamping length: max. 22mm
without a bur stop:
- Shaft clamping length: at least 30mm
- Shaft clamping length: max. 44.5mm
WARNING
Use of non-approved burs.
Injury to the patient or damage to the medical device.
4Comply with the instructions for use and the intended use of the bur.
4Only use burs that do not deviate from the specified data.
CAUTION
Contaminated, sharp-edged bur.
Infections or cuts.
4Use gloves or a finger guard when you test, insert and remove the bur.
CAUTION
Bur with damaged, worn or deformed shafts.
Risk of injury, bur may fall out during treatment.
4Never use burs with damaged, worn or deformed shafts.
CAUTION
Defective chuck system.
Risk of injury, bur may fall out during treatment.
4Pull on the bur to check if the chuck system is functioning properly and that
the bur is firmly clamped.
NOTICE
Bur with damaged, worn or deformed shafts.
Property damage to the chuck system, bur is difficult or impossible to remove
from the chuck system.
4Never use burs with damaged, worn or deformed shafts.
NOTICE
Incorrectly clamped bur.
Property damage to the chuck system, bur is difficult or impossible to remove
from the chuck system.
4Never use burs with shortened shafts.
4Never use burs that show recesses, tapering, diamond coding or cutting ge-
ometries in the section corresponding to the clamped length.

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5 Operation | 5.4 Remove the bur
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NOTICE
Bur shaft slips inside the chuck due to excessive speed of the bur or
abrupt engagement of the bur.
Property damage to bur shaft and chuck system, reduction of the service life of
bur and chuck system.
4Do not operate the bur at a higher speed than recommended by the manu-
facturer.
4Rotate the clamping ring sleeve in the direction of the arrow to the bur stop
and insert the bur in the chuck.
4Turn the clamping ring back into its initial position.
4Make sure that the bur is seated securely by pulling on it.
5.4 Remove the bur
WARNING
Rotating bur.
Cuts, infection and burn injury.
4Do not touch the bur while it is rotating.
4Remove the bur from the handpiece after treatment to avoid injury and in-
fection during storage.
4After the bur has come to a standstill, turn the clamping ring in the direction
of the arrow to the bur stop and remove the bur.
4Turn the clamping ring back into its initial position.
5.5 Modification for contra-angle burs
NOTE
The handpiece must be converted if you wish to use contra-angle burs.
4Open the handpiece chuck.
4Insert the enclosed bur stop in the chuck.
4Press the contra-angle bur onto the bur stop, close the clamping ring and
make sure that it is firmly seated.
4Use the enclosed hook to remove the bur stop.

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
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.
Burn injury or product damage due to over-heating.
4If the device overheats, stop working and have the service personnel repair
the device.
4If the medical device overheats when exposed to stress, 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
Use of NON-KaVo original spare parts in the repair.
Parts such as covers can become undone and cause injury. Aspiration, swallow-
ing of parts, 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 into the market of a modified product, where there is reason-
able suspicion that the safety and health of patients or users may be jeopar-
dized, is prohibited by the German medical device law §4, section 1 no. 1 and
requires a separate conformity check.
6.2.1 Cleaning the spray tube
WARNING
Hazard from contaminated products.
Patients, users or third parties can be infected by contaminated medical de-
vices.
4Prior to initial startup and after each use, process the product and acces-
sories.
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 channels and, if applicable, clean spray tubes with the
nozzle needle (Mat. No. 0.410.0931).

Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005
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 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.1 Preparations at the site of use
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7 Processing 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 may get infected by contaminated medical de-
vices.
4Take suitable personal protective measures.
WARNING
Sharp bur in the medical device.
Injury hazard from sharp and/or pointed bur.
4Remove the bur.
4To minimize the risk of infection during processing, always wear protective
gloves.
4Process the medical device right after treatment.
4Remove all residual cement, composite or blood immediately.
4Disinfect the medical device by wiping before transport.
4Remove the bur from the medical device.
4Do not immerse in solutions or the like.
NOTICE
Never process the medical device with chloride-containing products.
Malfunction and material damage.
4Process 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
Requisite consumables:
▪ 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 in accordance with the instructions of the disinfec-
tant manufacturer.
4Comply with the instructions for use of the disinfectant.
7.2 Manual processing
This product is not designed for manual internal and external cleaning and
manual internal and external disinfection.
For effective processing, a automated internal and external cleaning as well as
a automated internal and external disinfection with a washer-disinfector in ac-
cordance with ISO 15883-1 is required.