KaVo SMARTtorque S609 C User manual

Instructions for use
SMARTtorque S609 C - 1.008.1644
SMARTtorque Mini S605 C - 1.008.1645
SMARTtorque S608 C - 3.001.6560

Distributed by:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
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
3 Product description ............................................................................................................ 8
3.1 Intended use................................................................................................................. 8
3.2 Technical Specifications .................................................................................................. 9
3.3 Transportation and storage conditions.............................................................................. 9
4 Startup and shut-down.......................................................................................................11
4.1 Checking the water quantity ........................................................................................... 11
4.2 Checking the pressures .................................................................................................. 11
5 Operation............................................................................................................................ 13
5.1 Attaching the medical device........................................................................................... 13
5.2 Removing the medical device.......................................................................................... 13
5.3 Inserting the bur or diamond .......................................................................................... 13
5.4 Removing the bur or diamond......................................................................................... 14
6 Troubleshooting ................................................................................................................. 16
6.1 Cleaning the spray nozzle ............................................................................................... 16
7 Processing steps in accordance with ISO 17664 ...............................................................17
7.1 Preparations at the site of use......................................................................................... 17
7.2 Manual processing ......................................................................................................... 17
7.2.1 Manual external cleaning ..................................................................................... 17
7.2.2 Manual external disinfection................................................................................. 18
7.2.3 Manual drying .................................................................................................... 18
7.3 Automated processing.................................................................................................... 18
7.3.1 Automated internal and external cleaning and internal and external disinfection........ 19
7.3.2 Automated drying............................................................................................... 19
7.4 Care products and systems - Servicing............................................................................. 19
7.4.1 Servicing with KaVo Spray................................................................................... 20
7.4.2 Servicing with KaVo QUATTROcare PLUS............................................................... 20
7.5 Packaging ..................................................................................................................... 21
7.6 Sterilization................................................................................................................... 21
7.7 Storage ........................................................................................................................ 22
8 Optional aids.......................................................................................................................23
9 Terms and conditions of warranty .....................................................................................24
Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
Table of contents
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Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
1 User instructions
4 / 26
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
Please direct all questions regarding the product, service and maintenance to
the
KaVo Technical Service:
Toll-free: 1-888-ASK-KAVO (888-275-5286)
Email: [e-mail]
Please refer to the serial number of the product in all inquiries!
For repairs, please contact KaVo Repair Service.
For scheduling or if you have any questions, please contact:
KaVo Repair Service
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Toll-free Direct Customer Service: 1-888-ASK-KAVO (888-275-5286)
Email: [e-mail]
www.kavo.com
General marks and symbols
See Chapter on User Instructions/Hazard Levels
Important information for users and service technicians
Action request
Sterilization parameters
▪ Sterilizer with triple pre-vacuum:
- at least 3 minutes at 135°C (275 °F)
- Drying time: 16 min.
▪ Sterilizer using the gravity method:
- at least 10 minutes at 135°C (275 °F)
- Drying time: 30 min.
▪ Sterilizer using the gravity method:
- at least 60 minutes at 121°C (250 °F)
- Drying time: 15 min.
Thermodisinfectable
Information on the packaging
Catalog number

Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
1 User instructions
Serial number
Legal Manufacturer
CE mark according to Medical Devices Directive EC 93/42
Please note the electronic instructions for use
Caution: Consult instructions for use
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 range)
Protect from moisture (Keep dry)
Fragile, handle with care
HIBC Code
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:
DANGER
In cases which – if not prevented – directly lead to death or severe in-
jury.
WARNING
In cases which – if not prevented – can lead to death or severe injury.
CAUTION
In cases which – if not prevented – can lead to minor or moderate in-
jury.
NOTICE
In cases which – if not prevented – can lead to property damage.
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Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
2 Safety | 2.1 Infection hazard
6 / 26
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 can be infected by contaminated medical de-
vices.
▶Take suitable personal protective measures.
▶Follow the instructions for use of the components.
▶Before initial startup and after each use, process the product and acces-
sories appropriately.
▶Carry out the processing as described in the instructions for use. The proce-
dure has been validated by the manufacturer.
▶If you deviate from this procedure, it is essential to make sure that the pro-
cessing is effective.
▶Process the product and accessories appropriately before disposal.
▶In the case of injury to soft tissue, do not continue treatment in the oral
cavity with instruments driven by compressed air.
2.2 Technical condition
A damaged device or components can injure patients, users and third parties.
▶Use the device and components only if there is no damage on the outside.
▶Check to make sure that the device is working properly and is in satisfac-
tory 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 diamond is not firmly locked in the handpiece
To ensure optimum function and to prevent property damage, please comply
with the following instructions:
▶Service the medical device with care products and systems regularly as de-
scribed in the instructions for use.
▶The 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.

Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
2 Safety | 2.3 Accessories and combination with other equipment
2.3 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.
▶Only use accessories that have been approved for combination with the
product by the manufacturer.
▶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.
2.4 Qualification of personnel
Application of the product by users lacking appropriate medical training can in-
jure the patient, the user or third parties.
▶Make sure that the user has read and comprehends the instructions for use.
▶Only employ the device if the user has the appropriate medical training.
▶Comply with national and regional regulations.
Improper use of the device can lead to burns or injuries.
▶Never touch the handpiece head or handpiece lid to soft tissue.
▶After treatment, place the medical device properly in the cradle without the
tool.
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Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
3 Product description | 3.1 Intended use
8 / 26
3 Product description
SMARTtorque S609 C (Mat. no. 1.008.1644)
SMARTtorque Mini S605 C (Mat. no. 1.008.1645)
SMARTtorque S608 C (Mat. no. 3.001.6560)
The SMARTtorque is a dental handpiece in accordance with 21 CFR § 872.4200
(dental handpiece and accessories).
The SMARTtorque are air-driven dental handpieces, designed exclusively for
use by a trained professional in the field of general dental medicine. The de-
vices are air-driven handpieces that are reusable and ergonomically shaped,
and provided with a fiber optic light system. The devices can be sterilized in a
steam sterilizer (autoclave). Through the tube and the MULTIflex coupling con-
nected to a dental unit, the SMARTtorque handpieces receives the air for high
speed turbine, the cooling water and air for cutting treatment through pouring
holes and light for illumination of the operation area.
3.1 Intended use
Indications for use:
The SMARTtorque is intended for the removal of carious material, reduction of
hard tooth structure, cavity and crown preparations, removal of fillings, pro-
cessing and finishing tooth preparations, restorations, and for polishing teeth.
They may be used by trained professionals in general dental medicine exclu-
sively.
CAUTION
US Federal law restricts this device to sale by or on the order of a
healthcare professional / dentist.
For dental use only.

Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
3 Product description | 3.2 Technical Specifications
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
▪ adhere to the specified intended use
▪ protect himself or herself, the patient and third parties from danger
▪ avoid contamination from the product
3.2 Technical Specifications
S609 C S605 C S608 C
Water consumption > 50 ml/min*
Idle speed 350,000 to 400,000
min-1
350,000 to 450,000
min-1
350,000 to 400,000
min-1
Power/torque > 16 W (0.14 Ncm) > 13 W (0.12 Ncm) > 16 W (0.14 Ncm)
Head size Default Mini Default
Recommended operating
pressure
2 to 3 N
Minimal drive pressure 2.1 bar (30 psi)
Drive pressure 2.1 to 4.2 bar (30 to 61
psi)
2.1 to 4.2 bar (30 to 61
psi)
2.1 to 3.0 bar (30 to 44
psi)
Recommended drive
pressure
2.1 bar (30 psi)
Recommended water
pressure
0.8 to 1.0 bar (12 to 15 psi)
Air consumption 42 Nl/min 41 Nl/min 45 ± 5 Nl/min
*Consumption with water only
Note
The air consumption, idle speed, and power values were determined at a
drive pressure of 2.8 bar (40 psi).
SMARTtorque S609 C and SMARTtorque Mini S605 C:
Can be connected to all Midwest 4-hole connectors.
SMARTtorque S608 C:
Can be connected to all Borden 2-hole connectors.
3.3 Transportation and storage conditions
▶Do not store in a refrigerated environment.
Temperature: -20 °C to +70 °C (-4 °F to +158 °F)
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Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
3 Product description | 3.3 Transportation and storage conditions
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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 (Keep dry)

Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
4 Startup and shut-down | 4.1 Checking the water quantity
4 Startup and shut-down
WARNING
Hazard from non-sterile products.
Infection hazard for dentist and patient.
▶Before first use and after each use, process and sterilize the medical device
and accessories accordingly.
See also:
27 Processing steps in accordance with ISO 17664, Page 17
WARNING
Dispose of the product in the appropriate manner.
Infection hazard.
▶Before disposal, process and sterilize the product and accessories appropri-
ately.
See also:
27 Processing steps in accordance with ISO 17664, Page 17
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.
▶Adjust the water amount for the spray cooling to a minimum of 50 ml/min
(3.1 inch3).
▶Check the spray water channels and clean the spray nozzles with the nozzle
needle Mat. no. 0.410.0921, if needed.
4.2 Checking the pressures
NOTICE
Contaminated or moist compressed air at the compressed air connec-
tion.
Premature wear.
▶Supply dry, clean and uncontaminated compressed air in accordance with
ISO 7494-2 only.
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Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
4 Startup and shut-down | 4.2 Checking the pressures
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SMARTtorque S609 C and SMARTtorque Mini S605 C:
▶Insert the test gauge (Mat. no. 0.411.8731) between hose and medical
device and check the following pressures:
ðDrive pressure, drive pressure recommended, return air pressure, spray
water pressure, and spray air pressure.
SMARTtorque S608 C:
▶Insert the test gauge (Mat. no. 0.411.8731) between hose and medical
device and check the following pressures:
ðDrive pressure, recommended drive pressure and spray water pressure.
See also:
23.2 Technical Specifications, Page 9

Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
5 Operation | 5.1 Attaching the medical device
5 Operation
Note
At the beginning of each workday, the water-conducting systems should be
rinsed for at least 2 minutes (without transmission handpieces being at-
tached) and if there is a risk of contamination from reflux or back suction, the
system may also need to be rinsed for 20-30 seconds after each patient.
5.1 Attaching the medical device
WARNING
Detachment of the medical device during treatment.
A medical device that is not properly locked can release from the hose during
treatment.
▶Before each use, check if the medical device is securely locked onto the
hose by pulling on it.
▶Connect the coupling part of the medical device to the hose proceeding in
clockwise direction.
▶Pull on it to make sure that the medical device is securely attached to the
hose.
Note
The water quantity can be regulated through the coupling or the treatment
centre.
5.2 Removing the medical device
▶Firmly grasp the coupling and pull the medical device off while twisting
slightly.
5.3 Inserting the bur or diamond
Note
Only use carbide burs or diamonds that comply with ISO 1797-1 type 3, are
made of steel or hard metal and meet the following criteria:
- Shaft diameter: 1.59 to 1.60 mm
- Blade diameter: max. 2 mm
SMARTtorque S608 C and SMARTtorque S609 C:
- Overall length: max. 25mm
- Shaft clamping length: min. 11mm
SMARTtorque Mini S605 C:
- Overall length: max. 21mm
- Shaft clamping length: min. 9mm
WARNING
Use recommended dental burs or diamonds only.
Risk of injury.
▶Comply with the instructions for use and the intended use of the bur.
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Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
5 Operation | 5.4 Removing the bur or diamond
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CAUTION
Use of burs with worn or damaged shafts.
Risk of injury, tool may fall out during treatment.
▶Never use burs with damaged or worn shafts.
CAUTION
Danger of injury from bur.
Infections or cuts.
▶Wear gloves or finger guards.
CAUTION
Hazard from defective chucking system.
The bur could fall out and cause injury.
▶Pull on the bur to check if the clamping system works properly and the tool
is firmly clamped. Wear gloves or a finger guard when you check, insert or
remove the bits to prevent injury and infection.
NOTICE
Tool shaft slips inside the chuck due to excessive speed of the tool or
abrupt engagement of the tool.
Property damage to tool shaft and chuck system, reduction of the service life of
tool and chuck system.
▶Do not operate the tool at a higher speed than recommended by the manu-
facturer.
NOTICE
Use of burs with worn or damaged shafts.
Property damage to the chuck system, tool is difficult or impossible to remove
from the chuck system.
▶Do not use burs with damaged or worn shafts.
▶Forcefully press the push-button with your thumb and simultaneously insert
the bur to the limit stop.
▶Check that the bur is securely attached by pulling on it.
5.4 Removing the bur or diamond
WARNING
Hazard from rotating bur.
Cuts, infection and burn injury.
▶Never press the push-button while the bur is rotating.
▶Do not touch the bur while it is rotating!
▶Remove the bur from the contra-angle handpiece after treatment to avoid
injury and infection when putting it away.
NOTICE
Damage to the chucking system.
Property damage
▶Do not press the push-button while the bur is rotating.

Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
5 Operation | 5.4 Removing the bur or diamond
▶After the bur has stopped rotating, firmly press the push-button with your
thumb and simultaneously pull out the bur.
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Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
6 Troubleshooting | 6.1 Cleaning the spray nozzle
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6 Troubleshooting
6.1 Cleaning the spray nozzle
WARNING
Hazard from non-sterile products.
Infection hazard for dentist and patient.
▶Reprocess and sterilize the medical device properly before the next use.
CAUTION
Hazard from insufficient amount of spray water.
Overheating of the medical device and damage to the tooth.
▶Check the spray water channels and clean the spray nozzles with the nozzle
needle Mat. no. 0.410.0921, if needed.

Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
7 Processing steps in accordance with ISO 17664 | 7.1 Preparations at the site of use
7 Processing steps in accordance with ISO 17664
7.1 Preparations at the site of use
WARNING
Hazard from contaminated products.
Contaminated products are associated with an infection risk.
▶Take suitable personal protective measures.
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
▶Process the medical device as soon as possible after treatment.
▶To minimize the risk of infection during processing, always wear protective
gloves.
▶Remove the tool from the medical device.
▶Remove all residual cement, composite or blood immediately.
▶Do not immerse in solutions or the like.
7.2 Manual processing
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
NOTICE
Never process this medical device in an ultrasonic device.
Functional damage and property damage.
▶Clean manually or in a washer disinfector only.
7.2.1 Manual external cleaning
Accessories required:
▪ Tap water
▪ Brush, e.g. medium-hard toothbrush
▶Brush under flowing tap water.
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Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
7 Processing steps in accordance with ISO 17664 | 7.3 Automated processing
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7.2.2 Manual external disinfection
WARNING
Incomplete disinfection.
Infection hazard.
▶Only use disinfection procedures that are verified to be bactericidal, fungici-
dal 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 steril-
izer.
NOTICE
Never disinfect the handpiece with chlorine-containing products.
Functional damage and property damage.
▶Only disinfect in a washer disinfector or manually.
KaVo recommends the following products based on material compatibility. The
microbiological efficacy must be ensured by the disinfectant manufacturer and
proven by an expert opinion.
Approved disinfectants:
▪ CaviWipes and CaviCide made by Metrex
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 in accordance with the instructions of the
disinfectant manufacturer.
▶Comply with the instructions for use of the disinfectant.
7.2.3 Manual drying
▶Clean the outside and inside with compressed air until no drops of water are
visible.
▶Immediately after drying, lubricate the KaVo medical device with care
agents from the KaVo care system.
See also:
27.4 Care products and systems - Servicing, Page 19
7.3 Automated processing
WARNING
Incomplete disinfection.
Infection hazard.
▶Only use disinfection procedures that are verified to be bactericidal, fungici-
dal 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 steril-
izer.

Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
7 Processing steps in accordance with ISO 17664 | 7.4 Care products and systems - Servicing
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
NOTICE
Never disinfect the handpiece with chlorine-containing products.
Functional damage and property damage.
▶Only disinfect in a washer disinfector or manually.
NOTICE
Never process this medical device in an ultrasonic device.
Functional damage and property damage.
▶Clean manually or in a washer disinfector only.
7.3.1 Automated internal and external cleaning and
internal and external disinfection
KaVo recommends washer disinfectors in accordance with ISO 15883-1, which
are operated using alkaline cleaning agents.
▶For program settings as well as cleansers and disinfectants to be used,
please refer to the Instructions for Use of the washer disinfector.
7.3.2 Automated drying
The drying procedure is usually part of the cleaning program of the washer dis-
infector.
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.
7.4 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.
▶Perform regular proper care and servicing.
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Instructions for use SMARTtorque S609 C - 1.008.1644 SMARTtorque Mini S605 C - 1.008.1645 SMARTtorque
S608 C - 3.001.6560
7 Processing steps in accordance with ISO 17664 | 7.4 Care products and systems - Servicing
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Note
KaVo only guarantees that its products will function properly if the care prod-
ucts listed as accessories are used, since these products have been tested for
proper use on our products.
7.4.1 Servicing with KaVo Spray
KaVo recommends servicing the product as part of the processing after each
use, i.e. after each cleaning, disinfection, and before each sterilization.
▶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 once for 1-2 seconds.
Servicing the chuck
KaVo recommends servicing the chucking system once weekly.
▶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 once for 1-2 seconds.
7.4.2 Servicing with KaVo QUATTROcare PLUS
Servicing and cleaning device with expansion pressure for internal cleaning of
inorganic residues and optimum servicing.
KaVo recommends servicing the product as part of the processing after each
use, i.e. after each cleaning, disinfection, and before each sterilization.
▶Remove the tool from the medical device.
▶Service the product in the QUATTROcare PLUS.
See also:
2Instructions for use KaVo QUATTROcare PLUS
Servicing the chuck
KaVo recommends servicing the chuck system once a week using the chuck
servicing program integrated in the device.
Note
Handpieces must be taken off the service couplings before the chuck service
can be started and run.
▶Close the front door and press the chuck service button for at least three
seconds until the spray canister control LED flashes three times consecu-
tively.
ðThe device is in chuck service mode.