KaVo SURGmatic S201 C User manual

Instructions for use
SURGmatic S201 L - 1.009.0470
SURGmatic S201 C - 1.009.1100

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
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 ........................................................... 6
2.4 Qualification of personnel................................................................................................ 7
2.5 Service and repair.......................................................................................................... 7
3 Product description ............................................................................................................ 8
3.1 Purpose – Proper use ..................................................................................................... 8
3.2 Technical Specifications S201 L / S201 C.......................................................................... 8
3.3 Transportation and storage conditions.............................................................................. 9
4 Start up and shut down ......................................................................................................10
4.1 Checking the amount of water ........................................................................................ 10
5 Operation............................................................................................................................12
5.1 Inserting the head ......................................................................................................... 12
5.2 Pulling off the head ........................................................................................................ 12
5.3 Attaching the contra-angle handpiece to motor coupling .................................................... 13
5.4 Pulling the contra-angle handpiece off the motor coupling.................................................. 13
5.5 Inserting the milling tool or diamond grinder .................................................................... 13
5.6 Removing the milling tool or diamond grinder................................................................... 14
6 Troubleshooting .................................................................................................................15
6.1 Check for malfunctions................................................................................................... 15
6.2 Troubleshooting............................................................................................................. 15
6.2.1 Cleaning the spray clip and the spray tube ............................................................ 15
7 Reprocessing steps in accordance with ISO 17664 ...........................................................17
7.1 Preparation at the site of use .......................................................................................... 17
7.2 Non-fixing preliminary cleaning of the spray clip and spray tube ......................................... 17
7.3 Manual reprocessing ...................................................................................................... 18
7.3.1 Manual internal and external cleaning and internal and external disinfection ............. 18
7.3.2 Manual drying .................................................................................................... 18
7.4 Automated reprocessing................................................................................................. 18
7.4.1 Automated internal and external cleaning and internal and external disinfection........ 19
7.4.2 Automated drying............................................................................................... 19
7.5 Care products and systems - Servicing............................................................................. 20
7.5.1 Care with KaVo Spray ......................................................................................... 20
7.5.2 Servicing with KaVo QUATTROcare PLUS............................................................... 20
7.5.3 Care with KaVo SPRAYrotor ................................................................................. 21
7.5.4 Servicing with KaVo QUATTROcare ....................................................................... 22
7.6 Packaging ..................................................................................................................... 23
7.7 Sterilisation................................................................................................................... 23
7.8 Storage ........................................................................................................................ 23
8 Tools and consumables ......................................................................................................24
9 Terms and conditions of warranty .....................................................................................25
Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
Table of contents
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Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
1 User instructions
4 / 28
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
KaVo Original Factory Repair
In the event of a repair, please ship your product to the KaVo Original Factory Repair using www.ka-
vobox.com.
KaVo Technical Service
If you have any 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 office personnel.
The section on Commissioning is also intended for service technicians.
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.
Can be steam-sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4
oF)
Thermodisinfectable
Information on the packaging
Material number
Serial number

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
1 User instructions
Legal Manufacturer
CE mark according to Medical Devices Directive EC 93/42
Please note the electronic instructions for use
Note: observe accompanying documents
EAC conformity mark (Eurasian Conformity)
GOST R certification
Transportation and storage conditions
(Temperature range)
Transportation and storage conditions
(Air pressure)
Transportation and storage conditions
(Humidity)
Protect from moisture
Protect from impact
HIBC Code
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 in-
jury.
WARNING
In cases which – if not prevented – could lead to death or severe in-
jury.
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.
5 / 28

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
2 Safety | 2.1 Infection hazard
6 / 28
2 Safety
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.
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 use of the components.
▶Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
▶Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
▶If you deviate from this procedure, it is essential to make sure that the re-
processing is effective.
▶Reprocess the product and accessories appropriately before disposal.
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 Ser-
vice.
▶If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
▪ Dental bur or diamonds is not firmly locked in the handpiece
Observe the following instructions in order to guarantee optimum functioning
and prevent material damage:
▶Service the medical device with care products and systems regularly as de-
scribed in the instructions for use.
▶The device should be cleaned, serviced and stored in a dry location, accord-
ing to instructions, if it will not be used for a longer period.
2.3 Accessories and combination with other equipment
Use of un-authorised accessories or un-authorised modifications of the device
could lead to injury.

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
2 Safety | 2.4 Qualification of personnel
▶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 ap-
proved by the manufacturer of the product.
▶Use original KaVo spare parts only.
It is not permissible to combine this unit with other heads and bases as this
may lead to injury.
▶The SURGmatic S201 L/ C contra-angle handpiece consists of a base and a
head and must not be combined with other heads or bases.
The lack of control equipment for changing the speed range and the direction of
rotation 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 injure 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.
▶Never touch soft tissue with the handpiece head or instrument cover.
▶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
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:
▶Have the service and testing tasks carried out according to the Medical
Device Operator Ordinance.
▶After servicing, interventions on and repairs of the device and before re-
use, have the service personnel perform safety checks on the device.
▶Following expiry of the warranty, have the tool holding system checked
once a year.
▶KaVo 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.
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Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
3 Product description | 3.1 Purpose – Proper use
8 / 28
3 Product description
S201 L
SURGmatic
SURGmatic S201 L (Mat. no. 1.009.0470)
S201 C
SURGmatic
SURGmatic S201 C (Mat. no. 1.009.1100)
3.1 Purpose – Proper 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 use in the following applications: surgery e.g. placing an im-
plant, bone augmentation, sinus lift, dental extraction, implantology and
oromaxillary and 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 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
▪ to prevent contamination from the product
3.2 Technical Specifications S201 L / S201 C
CAUTION
It is not permissible to combine the unit with other heads / bases.
Risk of injury.
▶The SURGmatic S201 L/ C contra-angle handpiece consists of a base and a
head and must not be combined with other heads or bases.

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
3 Product description | 3.3 Transportation and storage conditions
Drive speed max. 40,000 rpm
Identification 1 green ring
Speed transmission 20 : 1
Torque max. 55 Ncm
With press-button chuck.
Usable with surgical drill bits or burs with inner cooling.
Internal cooling system (acc. Kirschner and Meyer) and external cooling-me-
dium connection.
The contra-angle handpiece can be mounted on all INTRAmatic (LUX) motors
and motors with a connector in accordance with ISO 3964 / DIN 13940.
3.3 Transportation and storage conditions
NOTICE
Startup after refrigerated storage.
Malfunction.
▶Prior 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: -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 / 28

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
4 Start up and shut down | 4.1 Checking the amount of water
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4 Start up and shut down
WARNING
Hazard from contaminated products.
Infection hazard for care provider and patient.
▶Prior to initial commissioning and after each use, reprocess the product and
accessories.
See also:
27 Reprocessing steps in accordance with ISO 17664, Page 17
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
▶Reprocess and sterilise the product and accessories before disposal.
See also:
27 Reprocessing steps in accordance with ISO 17664, Page 17
4.1 Checking 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 amount of 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 tube with the nozzle
needle (Mat. no. 0.410.0931) according to need.
▶Switch off spray-air and spray-water supply on the treatment device.

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
4 Start up and shut down | 4.1 Checking the amount of water
▶Cool the dental bur or diamond grinder via the external and/or internal
feed, if available. The supply can take place individually or via a coupling
piece.
▶During surgical interventions, comply with the necessary precautions re-
garding cooling.
▶Use physiological, sterile cooling fluid.
▶Ensure that the coolant supply is free of air.
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Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
5 Operation | 5.1 Inserting the head
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5 Operation
5.1 Inserting the head
WARNING
Detachment of the medical device during treatment.
If the head is not properly locked in place, it can become detached during
treatment.
▶Do not mount or remove the head while it is rotating. Before each treat-
ment, check that the head is firmly seated and that the clamping ring is
tight.
CAUTION
It is not permissible to combine the unit with other heads / bases.
Risk of injury.
▶The SURGmatic S201 L/ C contra-angle handpiece consists of a base and a
head and must not be combined with other heads or bases.
Note
The head of the SURGmatic S201 L / C contra-angle handpiece should be
taken off the base for reprocessing purposes only.
▶Rotate the clamping ring in the direction of the arrow until it hits the stop
and hold it there.
▶Insert the head to the stop. Make sure that the catches engage properly.
▶Rotate the clamping ring in the direction of the arrow (-> close) and tighten
it.
▶Attach the spray clip.
▶Make sure that the spray clip is securely affixed.
5.2 Pulling off the head
▶Pull the spray clip off.
▶Rotate the clamping ring in the direction of the arrow until it hits the stop
and hold it there.
▶Pull off the medical device.
▶Release the clamping ring.

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
5 Operation | 5.3 Attaching the contra-angle handpiece to motor coupling
5.3 Attaching the contra-angle handpiece to motor
coupling
WARNING
Detachment of the medical device during treatment.
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 securely locked onto the motor coupling.
NOTICE
Removing and attaching the straight or contra-angle handpiece while
the drive motor is rotating.
Damage to the driver.
▶Never attach or remove the straight or contra-angle handpiece while the
drive motor is rotating.
▶Lightly spray O-rings on motor coupling with KaVo Spray.
▶Attach the medical device to the motor coupling and turn it until the latch
audibly snaps into place.
▶Pull on the medical device to make sure that it is securely affixed to the
coupling.
5.4 Pulling the contra-angle handpiece off the motor
coupling
▶Unlock the medical device from the motor coupling by twisting it slightly
and then pulling it along its axis.
5.5 Inserting the milling tool or diamond grinder
Note
Only use carbide cutters or diamond drill bits that conform to EN ISO 1797-1
type 1, are made of steel or hard metal, and meet the following criteria:
- Shaft diameter: 2.334 to 2.350 mm
- Overall length: max. 45 mm
- Blade diameter: max. 10 mm
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 cutters or grinders.
Cutters or grinders could fall out during treatment and injure the patient.
▶Never use cutters or grinders with worn shafts.
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Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
5 Operation | 5.6 Removing the milling tool or diamond grinder
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CAUTION
Danger of injury from cutters or grinders.
Infections or cuts.
▶Wear gloves or finger stalls.
CAUTION
Hazard from defective chuck 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. Wear gloves or finger stalls when you
check, insert or remove the insert to prevent injury and infection.
▶Insert the bur or diamond grinder into the segment of the head drive by
twisting the tool slightly, and push it to the end stop. Activate the pushbut-
ton if necessary.
▶Check if the tool is seated securely by pulling on it.
5.6 Removing the milling tool or diamond grinder
WARNING
Hazard from rotating dental bur or diamond grinder.
Lacerations and damage to the chuck system.
▶Do not touch the dental bur or diamond grinder when it is rotating!
▶Do not press the push-button while the dental bur or diamond grinder is ro-
tating!
▶Remove the dental bur/diamond grinder from the contra-angle handpiece
after treatment to avoid injury and infection when putting it away.
▶After the dental bur or diamond grinder has stopped rotating, firmly press
the pushbutton with your thumb and simultaneously pull out the dental bur
or diamond grinder.

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
6 Troubleshooting | 6.1 Check for malfunctions
6 Troubleshooting
6.1 Check for malfunctions
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 Cleaning the spray clip and the spray tube
CAUTION
Hazard from insufficient amount of spray water.
Insufficient spray water can cause the medical device to overheat and damage
the tooth.
▶Check spray water channels and if necessary clean spray tubes with the
nozzle needle (Mat. no. 0.410.0931).
15 / 28

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
6 Troubleshooting | 6.2 Troubleshooting
16 / 28
▶Use the nozzle pin (Mat. no. 0.410.0931) to free the water passage on
the spray clip on both sides.

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparation at the site of use
7 Reprocessing steps in accordance with ISO 17664
7.1 Preparation at the site of use
WARNING
Hazard from contaminated products.
Contaminated products are associated with an infection hazard.
▶Take suitable personal protective measures.
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
▶Reprocess the medical device as soon as possible after treatment.
▶The medical device must be dry when transported to reprocessing.
▶To minimise the risk of infection during reprocessing, always wear protect-
ive gloves.
▶Remove the tool from the medical device.
▶Remove all residual cement, composite or blood immediately.
▶Do not place in solutions or similar substances.
7.2 Non-fixing preliminary cleaning of the spray clip and
spray tube
The non-fixing 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 pin
▪ Brush, e.g. medium-hard toothbrush
▪ Disposable syringe
Note
Before cleaning, take the hose off the spray clip and the contra-angle hand-
piece.
▶Check the patency of the spray clip and spray tube and clean them with the
nozzle pin (Mat. no. 0.410.0931).
▶Rinse the spray clip and spray tube with at least 20 ml demineralised water
using a disposable syringe.
▶If the spray clip and spray tube are not patent after the manual rinsing pro-
cedure, the medical device and/or the spray clip must be replaced.
17 / 28

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
7 Reprocessing steps in accordance with ISO 17664 | 7.3 Manual reprocessing
18 / 28
▶Brush the spray clip and spray tube under running tap water water for at
least 20 seconds using a medium-hard toothbrush.
For validated internal cleaning of the spray clip and spray tube in the cleaning
and disinfecting device, preliminary non-fixing cleaning is required.
7.3 Manual reprocessing
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
NOTICE
Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.
▶Clean it in a washer disinfector only.
Note
The spray clip for internal cooling may be additionally cleaned in the ultra-
sonic cleaner.
7.3.1 Manual internal and external cleaning and internal
and external disinfection
Not applicable.
7.3.2 Manual drying
▶Blow off the outside and inside with compressed air until water drops are no
longer visible.
▶Immediately after drying, lubricate the KaVo medical device with care
agents from the KaVo care system.
See also:
27.5 Care products and systems - Servicing, Page 20
7.4 Automated reprocessing
WARNING
Incomplete disinfection.
Infection hazard.
▶Only use disinfection procedures that are verified to be bactericidal, fungi-
cidal and virucidal.
▶If the disinfectants used do not meet these requirements, the process must
be concluded by disinfection of the unit(s) without packaging using a steam
steriliser.

Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
NOTICE
Never disinfect the handpiece with chloride-containing products.
Malfunction and material damage.
▶Only disinfect in the washer disinfector.
NOTICE
Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.
▶Clean it in a washer disinfector only.
Note
The spray clip for internal cooling may be additionally cleaned in the ultra-
sonic cleaner.
For validated internal cleaning of the spray clip and spray tube in the cleaning
and disinfecting device, preliminary non-fixing cleaning is required.
7.4.1 Automated internal and external cleaning and
internal and external disinfection
Note
Prior to cleaning or disinfection in a thermodisinfector, attach the head to an
appropriate shank.
KaVo recommends washer disinfectors according to EN ISO 15883-1, which
are operated using alkaline cleaning agents having a maximum pH value of 10.
The validation was performed in a Miele washer disinfector using the "VARIO-
TD" program, the "neodisher® mediclean" cleaning agent, the "neodisher® Z"
neutraliser, and the "neodisher® mielclear" rinsing agent.
▶For programme settings as well as cleansers and disinfectants to be used,
please refer to the Instructions for Use of the washer disinfector.
▶For the spray clip and spray tube, also use the adapter for external spray
channels.
7.4.2 Automated drying
The drying procedure is normally part of the cleaning programme of the washer
disinfector.
Note
Please comply with the instructions for use of the washer disinfector.
▶In order to prevent impairment of the KaVo medical device, make sure that
the inside and outside of the device is dry after the end of the cycle.
▶Immediately after drying, lubricate the KaVo medical device with care
agents from the KaVo care system.
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Instructions for use SURGmatic S201 L - 1.009.0470 SURGmatic S201 C - 1.009.1100
7 Reprocessing steps in accordance with ISO 17664 | 7.5 Care products and systems - Servicing
20 / 28
7.5 Care products and systems - Servicing
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
CAUTION
Improper service and care.
Risk of injury.
▶Service regularly with suitable agents.
Note
KaVo guarantees the proper function of KaVo products only if the care
products listed as accessories are used, since these were tested for proper
use on our products.
7.5.1 Care with KaVo Spray
Note
Head can be serviced alone or attached to a shank.
KaVo recommends servicing the product after each use, i.e. after each auto-
matic cleaning and before each sterilisation.
▶Remove the tool from the medical device.
▶Cover the medical device with the KaVo CLEANpac bag, and place it on the
corresponding care adapter.
▶Press the spray key for 1 to 2 seconds.
Care of chucking system
KaVo recommends cleaning and servicing the chuck system once a week.
▶Remove the tool from the medical device.
▶Position the tip of the spray nipple in the opening, and apply the spray.
▶Press the spray key for 1 to 2 seconds.
7.5.2 Servicing with KaVo QUATTROcare PLUS
Note
Head can be serviced alone or attached to a shank.
Cleaning and servicing device with expansion pressure for internal cleaning of
inorganic residues and optimum care.
(no validated cleaning of the interior according to German Robert Koch Institute
(RKI) requirements)